Postoperative PainNCT04731428
Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain, Anxiety in Colorectal Cancer Surgery
A study testing Progressive Relaxation Exercise in people with Postoperative Pain and Nursing Caries, run by YASEMİN ÖZHANLI at 1 site in Turkey (Türkiye).
Trial summary
This research was carried out as an pre-test/post-test control group experimental design study in order to determine the effect of progressive relaxation exercises on the level of vital sign, pain and anxiety underwent who laparoscopic surgery for colorectal cancer in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Nursing Caries, Anxiety
- What is being tested?
- Progressive Relaxation Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2018to 10 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years or over,
- Consenting to participate in the study with verbal and written declaration after being informed,
- Being scheduled for elective laparoscopic colorectal cancer surgery,
- Not participating in another randomized controlled study simultaneously.
Who cannot join
- Having a health problem that will alter cortisol release,
- Preoperative and postoperative unconsciousness,
- Having a psychiatric problem,
- Having a disease that requires corticosteroid therapy,
- Developing any complications during the operation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Istanbul Medical Faculty Hospital
Istanbul, 34000
About this study
Official title: The Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain and Anxiety in Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Study
This research was carried out as an pre-test/post-test control group experimental design study in order to determine the effect of progressive relaxation exercises on the level of vital sign, pain and anxiety underwent who laparoscopic surgery for colorectal cancer in patients. This research data was collected between March 2018 and May 2019. The research was carried out with 63 patients (experiment group= 31, control group= 32) who underwent elective laparoscopic colorectal surgery in a general surgery clinic of a university hospital in Istanbul and in accordance with the research criteria. Patients in the experiment group were taught breathing exercises in the preoperative period and on the 1st, 2nd and 3rd day after surgery then, progressive relaxation exercise that lasted 15 minutes was applied to the group. Pain (Short McGill Pain Scale) and anxiety (STAI-S Scale) levels of both groups were evaluated in the preoperative and postoperative period. The patient's vital signs, oxygen saturation and serum cortisol level parameters were measured in the same time interval before and after the relaxation exercise. Significance was evaluated at p <0.05 and p<0,001 levels in the analysis of the data. Prior to the study, the consent of the institution and ethics committee, written and verbal patient consent were obtained.
Read the detailed description
The universe of the study consisted of patients with colorectal cancer who were admitted to Istanbul University, Istanbul Faculty of Medicine, General Surgery Clinics for treatment between March 2018 and May 2019 and who would undergo laparoscopic surgery.The research was planned as a randomized controlled experimental study. Block randomization method was to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program(https://www.randomizer.org/) was used. Randomization done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list.Research data will be collected in a hospital's general surgery ward between March 2018 and May 2019. The independent variable of the study is Progressive Relaxation Exercise.The dependent variables of the study are physiological parameters, pain, anxiety and serum cortisol. In the research, "Individual Characteristics Form" and "Patient Follow-up Form" prepared by the researcher in line with the literature will be used as data collection tools.
- Conditions
- Postoperative Pain, Nursing Caries, Anxiety
- Being tested
- Progressive Relaxation Exercise
- Keywords
- Progressive relaxation exercise, Colorectal cancer surgery, Pain, Anxiety, Nursing care
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Relaxation ExerciseBehavioural
Progressive Relaxation Exercise involves stretching sixteen muscle groups while breathing in sequentially, relaxing while exhaling. Exercise can be from head to toe or from foot to head. In order for the technique to be effective, it is important to have affective (music, etc.) and visual aids. During the exercise, the patient should complete the processes of perceiving the tension in his body, maintaining control and getting into a state of relaxation. After the patient is informed about the exercise, the person starts with breathing exercises. A deep but relaxing breath is taken from the nose, and lips are given by contracting simultaneously with relaxation. During this application, the patient keeps contracting the muscle group that he exercises for 10 seconds; the nurse provides the patient to notice the temperature / warming felt in the muscle group.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Relaxation Exercise | Experimental | In individuals with normal daily circadian rhythms, cortisol levels peak at 8:00 AM, followed by a constantly declining daily cycle throughout the day. Therefore, it is important to collect blood samples taken for the measurement of serum cortisol levels approximately at the same time. Venous blood samples (3 ml) were obtained from the upper arm at 06:45 AM to evaluate the baseline and 45 minutes after Progressive Relaxation Exercise at 08:00. Vital signs and oxygen saturation were assessed at 6:30 AM before Progressive Relaxation Exercise and at 07:20 AM 5 minutes after Progressive Relaxation Exercise. Measurements were performed in the morning on the day of surgery and on postoperative days 1, 2, and 3. Receives: Behavioral: Progressive Relaxation Exercise |
| Standard Care | No intervention | In the control group, no application made during and after the surgical intervention, and routine treatment and care applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative pain severity
Pain severity assessment with Short Form McGill Pain Questionnaire In the first part, pain intensity is evaluated as 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain In the second part, the pain felt is evalauted using the Visuel Analog Scale (VAS).0-10; 0- No Pain, 10- Worst pain In the third part, the total pain intensity is measured with a 6-point Likert-type assessment. (0=no pain, 1=mild, 2=annoying , 3=troublesome, 4=miserable, 5=unbearable pain) Pain assessment for the experimental group Preoperative pain assessment of the experimental group was made before applying the progressive relaxation exercise. This evaluation was made 2 hours before surgery (6.30 am).
Pain assessment for the control group Preoperative pain assessment of the control group was made 2 hours before the operation in order to ensure the equivalence between the groups (6.30 am).
Measured: Preoperative pain assessment of the groups was made 2 hours before surgery.
Preoperative anxiety severity
Anxiety severity with Spielberger's State and Trait Anxiety Inventory State Anxiety Subscale are specified by choosing one of the options "1) not at all, 2) somewhat, 3) moderately so, and 4) very much so" according to the severity of such experiences.
Anxiety assessment for the experimental group Preoperative anxiety assessment of the experimental group was made before applying the progressive relaxation exercise. This evaluation was made 2 hours before surgery (6.30 am).
Anxiety assessment for the control group Preoperative anxiety assessment of the control group was made 2 hours before the operation in order to ensure the equivalence between the groups (6.30 am).
Measured: Preoperative anxiety assessment of the groups was made 2 hours before surgery.
Preoperative systolic and diastolic blood pressure (mmHg) (1st. assessment)
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device.
For experimental group The first evaluation was made before applying the progressive relaxation exercise(6.30 am).
For the control group The first evaluation was made 6.30am.
Measured: In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 2 hours before surgery.
Preoperative pulse rate (heart rate per minute) (1st. assessment)
Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter.
For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30 am).
For the control group The first evaluation was made 6.30am.
Measured: In the preoperative period, the pulse rate was evaluated 2 hours before surgery.
Preoperative respiratory rate (respiratory per minute) (1st. assessment)
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute.
For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am).
For the control group The first evaluation was made 6.30am.
Measured: In the preoperative period, respiratory rate was evaluated 2 hours before surgery.
Preoperative body temperature (Celcius) (1st. assessment)
Body temperature (Celcius)assessment was made with a digital thermometer. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am).
For the control group The first evaluation was made 6.30am.
Measured: In the preoperative period, body temperature was evaluated 2 hours before surgery
Preoperative oxygen saturation (SpO2) (1st. assessment)
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am).
For the control group The first evaluation was made 6.30am.
Measured: In the preoperative period, oxygen saturation was evaluated 2 hours before surgery.
Preoperative serum cortisol levels (1st. assessment)
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory.
For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.45 am).
For the control group The first evaluation was made 6.45am.
Measured: In the preoperative period, serum cortisol levels assessment of the groups was made 2 hours before surgery.
Use of analgesic (See Table 1)(in the first 24 hours after surgery)
In this section, dose (mg) of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 0 Opioid NSAİ Other
Measured: Analgesic consumption of the patients was recorded in the first 24 hours after surgery.
Preoperative systolic and diastolic blood pressure (mmHg) (2nd. assessment)
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device.
For experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.).
For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Measured: In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 1 hour before surgery.
Preoperative pulse rate (heart rate per minute) (2nd. assessment)
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute.
For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.).
For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Measured: In the preoperative period, the pulse rate was evaluated 1 hour before surgery.
Preoperative respiratory rate (respiratory per minute) (2nd. assessment)
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute.
For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.).
For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Measured: In the preoperative period, respiratory rate was evaluated 1 hour before surgery.
Preoperative body temperature (Celcius) (2nd. assessment)
Body temperature (Celcius)assessment was made with a digital thermometer. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.).
For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Measured: In the preoperative period, body temperature was evaluated 1 hour before surgery.
Preoperative oxygen saturation (SpO2) (2nd. assessment)
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.).
For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Measured: In the preoperative period, oxygen saturation was evaluated 1 hour before surgery.
Preoperative serum cortisol levels (2nd. assessment)
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory.
For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 45 minutes after the application (8.00am.).
For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 8.00am.
Measured: In the preoperative period, serum cortisol levels assessment of the groups was made 1 hour before surgery.
Use of analgesic (See Table 1)(postoperative 1st. day)
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Doses (mg) Postoperative 1 Opioid NSAİ Other
Measured: Analgesic consumption of the patients was recorded in the postoperative 1st. day.
Use of analgesic (See Table 1)(postoperative 2nd day)
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 2 Opioid NSAİ Other
Measured: Analgesic consumption of the patients was recorded in the postoperative 2nd. day.
Use of analgesic (See Table 1)(postoperative 3rd day)
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 3 Opioid NSAİ Other
Measured: Analgesic consumption of the patients was recorded in the postoperative 3rd. days.
Secondary outcomes (20)
Postoperative pain severity
Pain severity assessment with Short Form McGill Pain Questionnaire
For the experimental group The pain assessment of the experimental group in the postoperative period was made on the 3rd day after surgery. This evaluation was made 1 hour after the progressive relaxation exercise on the 3rd postoperative day (8.30 am).
For the control group Postoperative pain assessment of the control group was made on the 3rd day after surgery.
Postoperative pain assessment of the control group was made on the 3rd day after surgery. Post-operative pain assessment of the control group was performed at the same time (8.30 am) to ensure intergroup equivalence.
Measured: Postoperative pain assessment of the groups was made postoperative 3rd. day.
Postoperative anxiety severity
Anxiety severity with Spielberger's State and Trait Anxiety Inventory State Anxiety Subscale are specified by choosing one of the options "1) not at all, 2) somewhat, 3) moderately so, and 4) very much so" according to the severity of such experiences.
Anxiety assessment for the experimental group The anxiety assessment of the experimental group in the postoperative period was made on the 3rd day after surgery. This evaluation was made 1 hour after the progressive relaxation exercise on the 3rd postoperative day (8.30 am).
Anxiety assessment for the control group Postoperative anxiety assessment of the control group was made on the 3rd day after surgery.
Postoperative anxiety assessment of the control group was made on the 3rd day after surgery. Post-operative anxiety assessment of the control group was performed at the same time (8.30 am) to ensure intergroup equivalence.
Measured: Postoperative anxiety assessment of the groups was made postoperative 3rd. day.
Postoperative systolic and diastolic blood pressure (mmHg) (1st. assessment)
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device.
For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Measured: Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 1st. day.
Postoperative systolic and diastolic blood pressure (mmHg) (2nd. assessment)
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device.
For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Measured: Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 2nd. day.
Postoperative systolic and diastolic blood pressure (mmHg) (3rd. assessment)
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device.
For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Measured: Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 3rd. day.
Postoperative pulse rate (heart rate per minute) (1st. assessment)
Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter.
For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Measured: Pulse rate (heart rate per minute) evaluation was made on postoperative 1st. day.
Postoperative pulse rate (heart rate per minute) (2nd. assessment)
Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter.
For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Measured: Pulse rate (heart rate per minute) evaluation was made on postoperative 2nd. day.
Postoperative pulse rate (heart rate per minute) (3rd. assessment)
Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter.
For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Measured: Pulse rate (heart rate per minute) evaluation was made on postoperative 3rd. day.
Postoperative respiratory rate (respiratory per minute) (1st. assessment)
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute.
For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Measured: Respiratory rate (respiratory per minute) evaluations was made on postoperative 1st. day.
Postoperative respiratory rate (respiratory per minute) (2nd. assessment)
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute.
For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Measured: Respiratory rate (respiratory per minute) evaluations was made on postoperative 2nd. day.
Postoperative respiratory rate (respiratory per minute) (3rd. assessment)
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute.
For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Measured: Respiratory rate (respiratory per minute) evaluations was made on postoperative 3rd. day.
Postoperative body temperature (celcius) (1st. assessment)
Body temperature (celcius)assessment was made with a digital thermometer. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Measured: Body temperature (0C) evaluation was made on postoperative 1st. day.
Postoperative body temperature (celcius) (2nd. assessment)
Body temperature (celcius)assessment was made with a digital thermometer. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Measured: Body temperature (0C) evaluation was made on postoperative 2nd. day.
Postoperative body temperature (celcius) (3rd. assessment)
Body temperature (celcius)assessment was made with a digital thermometer. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Measured: Body temperature (0C) evaluation was made on postoperative 3rd. day.
Postoperative oxygen saturation (SpO2) (1st. assessment)
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Measured: Oxygen saturation (SpO2) evaluation was made on postoperative 1st. day.
Postoperative oxygen saturation (SpO2) (2nd. assessment)
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Measured: Oxygen saturation (SpO2) evaluation was made on postoperative 2nd. day.
Postoperative oxygen saturation (SpO2) (3rd. assessment)
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Measured: Oxygen saturation (SpO2) evaluation was made on postoperative 3rd. day.
Postoperative serum cortisol levels (1st. assessment)
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory.
For the experimental group The first day evaluation was made 45 minutes after applying the progressive relaxation exercise (8.00 am).
For the control group The first day evaluation was made 8.00 am. Progressive relaxation exercise wasn't applied because of was control group.
Measured: In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 1st. day.
Postoperative serum cortisol levels (2nd. assessment)
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory.
For the experimental group The second day evaluation was made 45 minutes after applying the progressive relaxation exercise (8.00 am).
For the control group The second day evaluation was made 8.00 am. Progressive relaxation exercise wasn't applied because of was control group.
Measured: In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 2nd. day.
Postoperative serum cortisol levels (3rd. assessment)
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory.
For the experimental group The third day evaluation was made 45 minutes after applying the progressive relaxation exercise (8.00 am).
For the control group The third day evaluation was made 8.00 am. Progressive relaxation exercise wasn't applied because of was control group.
Measured: In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 3rd. day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start15 Mar 2018
- Primary completion30 May 2019
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Study
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- YASEMİN ÖZHANLI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YASEMİN ÖZHANLI, Kocaeli University
- Investigators
- Nuray Akyüz, Assoc. Prof., Study director, Istanbul University - CerrahpasaYasemin Özhanlı, PhD, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731428
- Sponsor's protocol ID
- 2018/141525
- Other IDs
- 2018
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozhanli Y, Akyuz N. The Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain and Anxiety Levels of Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Study. J Perianesth Nurs. 2022 Apr;37(2):238-246. doi: 10.1016/j.jopan.2021.08.008. Epub 2021 Dec 10.
PubMed 34903440
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain and Anxiety in Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04731428
- Acronym / sponsor ID
- 2018/141525
- Conditions
- Postoperative Pain, Nursing Caries, Anxiety
- Keywords
- Progressive relaxation exercise, Colorectal cancer surgery, Pain, Anxiety, Nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- YASEMİN ÖZHANLIUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research was carried out as an pre-test/post-test control group experimental design study in order to determine the effect of progressive relaxation exercises on the level of vital sign, pain and anxiety underwent who laparoscopic surgery for colorectal cancer in patients. This research data was collected between March 2018 and May 2019. The research was carried out with 63 patients (experiment group= 31, control group= 32) who underwent elective laparoscopic colorectal surgery in a general surgery clinic of a university hospital in Istanbul and in accordance with the research criteria. Patients in the experiment group were taught breathing exercises in the preoperative period and on the 1st, 2nd and 3rd day after surgery then, progressive relaxation exercise that lasted 15 minutes was applied to the group. Pain (Short McGill Pain Scale) and anxiety (STAI-S Scale) levels of both groups were evaluated in the preoperative and postoperative period. The patient's vital signs, oxygen saturation and serum cortisol level parameters were measured in the same time interval before and after the relaxation exercise. Significance was evaluated at p <0.05 and p<0,001 levels in the analysis of the data. Prior to the study, the consent of the institution and ethics committee, written and verbal patient consent were obtained.
Detailed description
The universe of the study consisted of patients with colorectal cancer who were admitted to Istanbul University, Istanbul Faculty of Medicine, General Surgery Clinics for treatment between March 2018 and May 2019 and who would undergo laparoscopic surgery.The research was planned as a randomized controlled experimental study. Block randomization method was to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program(https://www.randomizer.org/) was used. Randomization done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list.Research data will be collected in a hospital's general surgery ward between March 2018 and May 2019. The independent variable of the study is Progressive Relaxation Exercise.The dependent variables of the study are physiological parameters, pain, anxiety and serum cortisol. In the research, "Individual Characteristics Form" and "Patient Follow-up Form" prepared by the researcher in line with the literature will be used as data collection tools.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Progressive Relaxation Exercise | Experimental | Behavioral: Progressive Relaxation ExerciseIn individuals with normal daily circadian rhythms, cortisol levels peak at 8:00 AM, followed by a constantly declining daily cycle throughout the day. Therefore, it is important to collect blood samples taken for the measurement of serum cortisol levels approximately at the same time. Venous blood samples (3 ml) were obtained from the upper arm at 06:45 AM to evaluate the baseline and 45 minutes after Progressive Relaxation Exercise at 08:00. Vital signs and oxygen saturation were assessed at 6:30 AM before Progressive Relaxation Exercise and at 07:20 AM 5 minutes after Progressive Relaxation Exercise. Measurements were performed in the morning on the day of surgery and on postoperative days 1, 2, and 3. |
| Standard Care | No intervention | –In the control group, no application made during and after the surgical intervention, and routine treatment and care applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18 years or over,
- Consenting to participate in the study with verbal and written declaration after being informed,
- Being scheduled for elective laparoscopic colorectal cancer surgery,
- Not participating in another randomized controlled study simultaneously.
Key exclusion criteria (5 listed)
- Having a health problem that will alter cortisol release,
- Preoperative and postoperative unconsciousness,
- Having a psychiatric problem,
- Having a disease that requires corticosteroid therapy,
- Developing any complications during the operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Relaxation ExerciseProgressive Relaxation Exercise involves stretching sixteen muscle groups while breathing in sequentially, relaxing while exhaling. Exercise can be from head to toe or from foot to head. In order for the technique to be effective, it is important to have affective (music, etc.) and visual aids. During the exercise, the patient should complete the processes of perceiving the tension in his body, maintaining control and getting into a state of relaxation. After the patient is informed about the exercise, the person starts with breathing exercises. A deep but relaxing breath is taken from the nose, and lips are given by contracting simultaneously with relaxation. During this application, the patient keeps contracting the muscle group that he exercises for 10 seconds; the nurse provides the patient to notice the temperature / warming felt in the muscle group. | Behavioural | Progressive Relaxation Exercise |
Primary outcome
Preoperative pain severity
Time frame: Preoperative pain assessment of the groups was made 2 hours before surgery.
Pain severity assessment with Short Form McGill Pain Questionnaire In the first part, pain intensity is evaluated as 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain In the second part, the pain felt is evalauted using the Visuel Analog Scale (VAS).0-10; 0- No Pain, 10- Worst pain In the third part, the total pain intensity is measured with a 6-point Likert-type assessment. (0=no pain, 1=mild, 2=annoying , 3=troublesome, 4=miserable, 5=unbearable pain) Pain assessment for the experimental group Preoperative pain assessment of the experimental group was made before applying the progressive relaxation exercise. This evaluation was made 2 hours before surgery (6.30 am). Pain assessment for the control group Preoperative pain assessment of the control group was made 2 hours before the operation in order to ensure the equivalence between the groups (6.30 am).
Preoperative anxiety severity
Time frame: Preoperative anxiety assessment of the groups was made 2 hours before surgery.
Anxiety severity with Spielberger's State and Trait Anxiety Inventory State Anxiety Subscale are specified by choosing one of the options "1) not at all, 2) somewhat, 3) moderately so, and 4) very much so" according to the severity of such experiences. Anxiety assessment for the experimental group Preoperative anxiety assessment of the experimental group was made before applying the progressive relaxation exercise. This evaluation was made 2 hours before surgery (6.30 am). Anxiety assessment for the control group Preoperative anxiety assessment of the control group was made 2 hours before the operation in order to ensure the equivalence between the groups (6.30 am).
Preoperative systolic and diastolic blood pressure (mmHg) (1st. assessment)
Time frame: In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 2 hours before surgery.
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device. For experimental group The first evaluation was made before applying the progressive relaxation exercise(6.30 am). For the control group The first evaluation was made 6.30am.
Preoperative pulse rate (heart rate per minute) (1st. assessment)
Time frame: In the preoperative period, the pulse rate was evaluated 2 hours before surgery.
Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30 am). For the control group The first evaluation was made 6.30am.
Preoperative respiratory rate (respiratory per minute) (1st. assessment)
Time frame: In the preoperative period, respiratory rate was evaluated 2 hours before surgery.
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am). For the control group The first evaluation was made 6.30am.
Preoperative body temperature (Celcius) (1st. assessment)
Time frame: In the preoperative period, body temperature was evaluated 2 hours before surgery
Body temperature (Celcius)assessment was made with a digital thermometer. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am). For the control group The first evaluation was made 6.30am.
Preoperative oxygen saturation (SpO2) (1st. assessment)
Time frame: In the preoperative period, oxygen saturation was evaluated 2 hours before surgery.
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am). For the control group The first evaluation was made 6.30am.
Preoperative serum cortisol levels (1st. assessment)
Time frame: In the preoperative period, serum cortisol levels assessment of the groups was made 2 hours before surgery.
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.45 am). For the control group The first evaluation was made 6.45am.
Use of analgesic (See Table 1)(in the first 24 hours after surgery)
Time frame: Analgesic consumption of the patients was recorded in the first 24 hours after surgery.
In this section, dose (mg) of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 0 Opioid NSAİ Other
Preoperative systolic and diastolic blood pressure (mmHg) (2nd. assessment)
Time frame: In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 1 hour before surgery.
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device. For experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Preoperative pulse rate (heart rate per minute) (2nd. assessment)
Time frame: In the preoperative period, the pulse rate was evaluated 1 hour before surgery.
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Preoperative respiratory rate (respiratory per minute) (2nd. assessment)
Time frame: In the preoperative period, respiratory rate was evaluated 1 hour before surgery.
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Preoperative body temperature (Celcius) (2nd. assessment)
Time frame: In the preoperative period, body temperature was evaluated 1 hour before surgery.
Body temperature (Celcius)assessment was made with a digital thermometer. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Preoperative oxygen saturation (SpO2) (2nd. assessment)
Time frame: In the preoperative period, oxygen saturation was evaluated 1 hour before surgery.
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Preoperative serum cortisol levels (2nd. assessment)
Time frame: In the preoperative period, serum cortisol levels assessment of the groups was made 1 hour before surgery.
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 45 minutes after the application (8.00am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 8.00am.
Use of analgesic (See Table 1)(postoperative 1st. day)
Time frame: Analgesic consumption of the patients was recorded in the postoperative 1st. day.
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Doses (mg) Postoperative 1 Opioid NSAİ Other
Use of analgesic (See Table 1)(postoperative 2nd day)
Time frame: Analgesic consumption of the patients was recorded in the postoperative 2nd. day.
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 2 Opioid NSAİ Other
Use of analgesic (See Table 1)(postoperative 3rd day)
Time frame: Analgesic consumption of the patients was recorded in the postoperative 3rd. days.
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 3 Opioid NSAİ Other
20 secondary outcomes
Postoperative pain severity
Time frame: Postoperative pain assessment of the groups was made postoperative 3rd. day.
Postoperative anxiety severity
Time frame: Postoperative anxiety assessment of the groups was made postoperative 3rd. day.
Postoperative systolic and diastolic blood pressure (mmHg) (1st. assessment)
Time frame: Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 1st. day.
Postoperative systolic and diastolic blood pressure (mmHg) (2nd. assessment)
Time frame: Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 2nd. day.
Postoperative systolic and diastolic blood pressure (mmHg) (3rd. assessment)
Time frame: Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 3rd. day.
Postoperative pulse rate (heart rate per minute) (1st. assessment)
Time frame: Pulse rate (heart rate per minute) evaluation was made on postoperative 1st. day.
Postoperative pulse rate (heart rate per minute) (2nd. assessment)
Time frame: Pulse rate (heart rate per minute) evaluation was made on postoperative 2nd. day.
Postoperative pulse rate (heart rate per minute) (3rd. assessment)
Time frame: Pulse rate (heart rate per minute) evaluation was made on postoperative 3rd. day.
Postoperative respiratory rate (respiratory per minute) (1st. assessment)
Time frame: Respiratory rate (respiratory per minute) evaluations was made on postoperative 1st. day.
Postoperative respiratory rate (respiratory per minute) (2nd. assessment)
Time frame: Respiratory rate (respiratory per minute) evaluations was made on postoperative 2nd. day.
Postoperative respiratory rate (respiratory per minute) (3rd. assessment)
Time frame: Respiratory rate (respiratory per minute) evaluations was made on postoperative 3rd. day.
Postoperative body temperature (celcius) (1st. assessment)
Time frame: Body temperature (0C) evaluation was made on postoperative 1st. day.
Postoperative body temperature (celcius) (2nd. assessment)
Time frame: Body temperature (0C) evaluation was made on postoperative 2nd. day.
Postoperative body temperature (celcius) (3rd. assessment)
Time frame: Body temperature (0C) evaluation was made on postoperative 3rd. day.
Postoperative oxygen saturation (SpO2) (1st. assessment)
Time frame: Oxygen saturation (SpO2) evaluation was made on postoperative 1st. day.
Postoperative oxygen saturation (SpO2) (2nd. assessment)
Time frame: Oxygen saturation (SpO2) evaluation was made on postoperative 2nd. day.
Postoperative oxygen saturation (SpO2) (3rd. assessment)
Time frame: Oxygen saturation (SpO2) evaluation was made on postoperative 3rd. day.
Postoperative serum cortisol levels (1st. assessment)
Time frame: In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 1st. day.
Postoperative serum cortisol levels (2nd. assessment)
Time frame: In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 2nd. day.
Postoperative serum cortisol levels (3rd. assessment)
Time frame: In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 3rd. day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Derived from this study: PubMed 34903440Ozhanli Y, Akyuz N. The Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain and Anxiety Levels of Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Study. J Perianesth Nurs. 2022 Apr;37(2):238-246. doi: 10.1016/j.jopan.2021.08.008. Epub 2021 Dec 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuray Akyüz, Assoc. Prof. study director
Istanbul University - Cerrahpasa
Yasemin Özhanlı, PhD study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Relaxation Exercise in people with Postoperative Pain and Nursing Caries, run by YASEMİN ÖZHANLI at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative pain severity (time frame: Preoperative pain assessment of the groups was made 2 hours before surgery.). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04731428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.