Laparoscopic Cholecystectomy SurgeryNCT06749626
Progressive Relaxation Exercises Applied After Laparoscopic Cholecystectomy Surgery; Pain Intensity, Physiological Parameters, Anxiety and Its Effect on Discharge
A study testing progressive relaxation exercise in people with Laparoscopic Cholecystectomy Surgery, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
INTRODUCTION: Among gastrointestinal system diseases, gallbladder diseases are the most common. As is the case after every surgical intervention, changes occur in the patient's homeostasis after laparoscopic cholecystectomy surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy Surgery
- What is being tested?
- progressive relaxation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Sep 2023to 18 Sep 2024
- 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
- Volunteer to participate in the research,
- No visual or auditory problems,
- Able to speak and understand Turkish,
- No diagnosed psychiatric problems,
- No complications such as bleeding, nausea or vomiting after laparoscopic cholecystectomy surgery,
- Not using patient-controlled analgesia and opioids for postoperative pain control,
- Patients with a pain score ≥4 according to the Visual Comparison Scale will be included.
Who cannot join
- Those who do not volunteer to participate in the research,
- Having visual or auditory problems,
- Those who cannot speak or understand Turkish,
- Having a diagnosed psychiatric problem,
- Complications such as bleeding, nausea and vomiting occur after laparoscopic cholecystectomy surgery,
- Using patient-controlled analgesia and opioids for postoperative pain control,
- Patients with a pain score <4 according to the Visual Comparison Scale will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
INTRODUCTION: Among gastrointestinal system diseases, gallbladder diseases are the most common. As is the case after every surgical intervention, changes occur in the patient's homeostasis after laparoscopic cholecystectomy surgery. Studies have shown that more than half of the patients experience moderate to severe pain in the postoperative period. In addition, postoperative pain negatively affects the patients' quality of life by reducing their comfort levels. Progressive relaxation exercises, one of the cognitive-behavioral techniques, aim to gradually contract and relax the patients' muscles. Progressive relaxation exercises; It provides stabilization in physiological parameters by reducing pain caused by muscle tension and increased sympathetic activity after surgery.
At the end of this initiative, it is anticipated that the patient's comfort and satisfaction will increase, the healing process will accelerate, the duration of hospital stay will decrease and, accordingly, hospital care costs will decrease.
Read more
PURPOSE: The aim of the thesis study is to determine the progressive relaxation exercises applied after laparoscopic cholecystectomy surgery; To evaluate pain intensity, physiological parameters, anxiety and its effect on discharge.
METHOD: Planned as a randomized controlled experimental study, patients who underwent laparoscopic cholecystectomy surgery at Bartın State Hospital General Surgery Clinic were evaluated according to the algorithm created by the computer program (https://www.randomizer.org/) using numbers from 1 to 102. It will be randomly divided into 2 blocks. A two-block randomization will be made, the first block will be determined as the control group and the second block will be determined as the experimental group. There will be 104 patients in total, 52 in each group. In addition to routine treatment, patients in the experimental group will receive progressive relaxation exercises at the 6th and 10th hour after surgery. After the application, the effect of changes on the patients' pain, physiological parameters, anxiety and discharge will be recorded. 'Data Collection Form', 'Visual Comparison Scale (VAS)', 'Physiological Parameters Monitoring Form', 'State-Trait Anxiety Scale' and 'Readiness for Discharge Scale' will be used to collect data. The analysis of the collected data will be evaluated using the SPSS for Windows 22 program.
- Conditions
- Laparoscopic Cholecystectomy Surgery
- Being tested
- progressive relaxation exercise
- Keywords
- pain, anxiety, physiological parameters, laparoscopic cholecystectomy, progressive relaxation exercise, discharge
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive relaxation exerciseOther
Relaxation exercises CD developed by the Turkish Psychologists Association; It consists of muscle exercises, rhythmic breathing and music recital. The CD content, which includes relaxation exercises accompanied by music, was prepared by Psychologist Elif Kabak and voiced by Tülay Bursa. The CD, which includes deep breathing and muscle relaxation exercises, consists of three parts. The first section includes the definition of deep relaxation, the purpose of relaxation exercises and the rules to be considered in exercise practice. In the second part; There are relaxation exercises with audio instructions accompanied by streaming sounds. The third part contains relaxation music without instructions. After the information in the first part of the CD is explained to the patients in the experimental group, the second part, which lasts only approximately 30 minutes, will be administered under the supervision of the researcher. However, since the patients have undergone abdominal surgery, the
| Study group | Role | What they receive |
|---|---|---|
| Group undergoing progressive relaxation exercise after laparoscopic cholecystectomy surgery | Experimental | Progressive relaxation exercises lasting approximately 30 minutes were applied to the patients in the experimental group, accompanied by the researcher, at the 6th hour, when the nonsteroidal anti-inflammatory drug administered by the clinic was half-done, and at the 10th hour after the surgery. Receives: Other: progressive relaxation exercise |
| Group without progressive relaxation exercise after laparoscopic cholecystectomy surgery | No intervention | Patients in the control group were treated only according to the clinical analgesia protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale- VAS
The scale consists of a vertical or horizontal 10 cm straight line and the starting point is 0 and the ending point is 10 cm. The patient is asked to mark where the severity of his pain corresponds to on this line. On the scale, "0" defines the absence of pain and "10" defines the highest unbearable pain.
Measured: For the experimental group, before the progressive relaxation exercise and after the progressive relaxation exercise applied at the 6th and 10th hours, for the control group, before the 6th hour without the progressive relaxation exercise, at the 6th and
State-Trait Anxiety Scale
State Anxiety Scale is a rating scale consisting of 20 items that aims to determine how individuals feel at a certain moment and under conditions. This scale consists of 4-point Likert type answer options; (1) "not at all", (2) "somewhat", (3) "a lot", (4) "completely". After the surgery, the patient is asked to evaluate how he feels "right now" and score the severity of the anxiety states mentioned in each item according to Likert-type expressions. Trait Anxiety Scale is an assessment scale consisting of 20 items that aims to determine how you feel regardless of your current situation. It asks participants to indicate how often they feel anxiety in their general life. The individual is asked to evaluate how he/she "usually" feels by using the following statements on a 4-point Likert-type scale: (1) "almost never", (2) "sometimes", (3) "a lot of the time", (4) "almost always". asked to choose one
Measured: For the experimental group, before the progressive relaxation exercise and after the progressive relaxation exercise applied at the 6th and 10th hours, for the control group, before the 6th hour without the progressive relaxation exercise, at the 6th and
Discharge Readiness Scale
The scale has a total of eight items and four subscales. The first and second questions measure how the patient feels during the day, the third and fourth questions measure his knowledge about discharge, the fifth and sixth questions measure how and to what extent he can continue his daily life at home after discharge, and the seventh and eighth questions measure the support he can receive at home after he is discharged. The average total score obtained from the scale is considered very ready for discharge between 9-10, very ready for discharge between 8-8.9, moderately ready between 7-7.9, and low ready if below 7.
Measured: It will be applied to patients in both groups the day after surgery.
Physiological Parameters Monitoring Form
In the form, patients' systolic and diastolic blood pressure, body temperature, pulse rate, respiratory rate and oxygen saturation are evaluated.
Measured: For the experimental group, before the progressive relaxation exercise and after the progressive relaxation exercise applied at the 6th and 10th hours, for the control group, before the 6th hour without the progressive relaxation exercise, at the 6th and
Data Collection Form
It was prepared in line with the literature information scanned by the researcher and consists of two parts. In the first part, it is about evaluating the sociodemographic characteristics of the patient; It includes age, education level, height-weight, marital status, profession, working status, chronic diseases, constantly used medications and smoking. In the second part, it is about evaluating the clinical characteristics of the patient; It includes questions evaluating the presence of previous surgery, the duration of the surgery, the presence and type of analgesia administered after the surgery, and the date of hospitalization and discharge.
Measured: The Data Collection Form will be filled out at least 1 hour before the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start23 Sep 2023
- Primary completion17 Sep 2024
- Study completion18 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Cholecystectomy SurgeryStudies 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
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buse Dinçer, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749626
- Sponsor's protocol ID
- BartınU- SBF- BD- 01
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not want IPD to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Relaxation Exercises Applied After Laparoscopic Cholecystectomy Surgery; Pain Intensity, Physiological Parameters, Anxiety and Its Effect on Discharge
- ClinicalTrials.gov ID
- NCT06749626
- Acronym / sponsor ID
- BartınU- SBF- BD- 01
- Conditions
- Laparoscopic Cholecystectomy Surgery
- Keywords
- pain, anxiety, physiological parameters, laparoscopic cholecystectomy, progressive relaxation exercise, discharge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 23 Sep 2023 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 27 Dec 2024 (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.
INTRODUCTION: Among gastrointestinal system diseases, gallbladder diseases are the most common. As is the case after every surgical intervention, changes occur in the patient's homeostasis after laparoscopic cholecystectomy surgery. Studies have shown that more than half of the patients experience moderate to severe pain in the postoperative period. In addition, postoperative pain negatively affects the patients' quality of life by reducing their comfort levels. Progressive relaxation exercises, one of the cognitive-behavioral techniques, aim to gradually contract and relax the patients' muscles. Progressive relaxation exercises; It provides stabilization in physiological parameters by reducing pain caused by muscle tension and increased sympathetic activity after surgery.
At the end of this initiative, it is anticipated that the patient's comfort and satisfaction will increase, the healing process will accelerate, the duration of hospital stay will decrease and, accordingly, hospital care costs will decrease.
PURPOSE: The aim of the thesis study is to determine the progressive relaxation exercises applied after laparoscopic cholecystectomy surgery; To evaluate pain intensity, physiological parameters, anxiety and its effect on discharge.
METHOD: Planned as a randomized controlled experimental study, patients who underwent laparoscopic cholecystectomy surgery at Bartın State Hospital General Surgery Clinic were evaluated according to the algorithm created by the computer program (https://www.randomizer.org/) using numbers from 1 to 102. It will be randomly divided into 2 blocks. A two-block randomization will be made, the first block will be determined as the control group and the second block will be determined as the experimental group. There will be 104 patients in total, 52 in each group. In addition to routine treatment, patients in the experimental group will receive progressive relaxation exercises at the 6th and 10th hour after surgery. After the application, the effect of changes on the patients' pain, physiological parameters, anxiety and discharge will be recorded. 'Data Collection Form', 'Visual Comparison Scale (VAS)', 'Physiological Parameters Monitoring Form', 'State-Trait Anxiety Scale' and 'Readiness for Discharge Scale' will be used to collect data. The analysis of the collected data will be evaluated using the SPSS for Windows 22 program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group undergoing progressive relaxation exercise after laparoscopic cholecystectomy surgery | Experimental | Other: progressive relaxation exerciseProgressive relaxation exercises lasting approximately 30 minutes were applied to the patients in the experimental group, accompanied by the researcher, at the 6th hour, when the nonsteroidal anti-inflammatory drug administered by the clinic was half-done, and at the 10th hour after the surgery. |
| Group without progressive relaxation exercise after laparoscopic cholecystectomy surgery | No intervention | –Patients in the control group were treated only according to the clinical analgesia protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteer to participate in the research,
- No visual or auditory problems,
- Able to speak and understand Turkish,
- No diagnosed psychiatric problems,
- No complications such as bleeding, nausea or vomiting after laparoscopic cholecystectomy surgery,
Key exclusion criteria (7 listed)
- Those who do not volunteer to participate in the research,
- Having visual or auditory problems,
- Those who cannot speak or understand Turkish,
- Having a diagnosed psychiatric problem,
- Complications such as bleeding, nausea and vomiting occur after laparoscopic cholecystectomy surgery,
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 exerciseRelaxation exercises CD developed by the Turkish Psychologists Association; It consists of muscle exercises, rhythmic breathing and music recital. The CD content, which includes relaxation exercises accompanied by music, was prepared by Psychologist Elif Kabak and voiced by Tülay Bursa. The CD, which includes deep breathing and muscle relaxation exercises, consists of three parts. The first section includes the definition of deep relaxation, the purpose of relaxation exercises and the rules to be considered in exercise practice. In the second part; There are relaxation exercises with audio instructions accompanied by streaming sounds. The third part contains relaxation music without instructions. After the information in the first part of the CD is explained to the patients in the experimental group, the second part, which lasts only approximately 30 minutes, will be administered under the supervision of the researcher. However, since the patients have undergone abdominal surgery, the | Other | Group undergoing progressive relaxation exercise after laparoscopic cholecystectomy surgery |
Primary outcome
Visual Analog Scale- VAS
Time frame: For the experimental group, before the progressive relaxation exercise and after the progressive relaxation exercise applied at the 6th and 10th hours, for the control group, before the 6th hour without the progressive relaxation exercise, at the 6th and
The scale consists of a vertical or horizontal 10 cm straight line and the starting point is 0 and the ending point is 10 cm. The patient is asked to mark where the severity of his pain corresponds to on this line. On the scale, "0" defines the absence of pain and "10" defines the highest unbearable pain.
State-Trait Anxiety Scale
Time frame: For the experimental group, before the progressive relaxation exercise and after the progressive relaxation exercise applied at the 6th and 10th hours, for the control group, before the 6th hour without the progressive relaxation exercise, at the 6th and
State Anxiety Scale is a rating scale consisting of 20 items that aims to determine how individuals feel at a certain moment and under conditions. This scale consists of 4-point Likert type answer options; (1) "not at all", (2) "somewhat", (3) "a lot", (4) "completely". After the surgery, the patient is asked to evaluate how he feels "right now" and score the severity of the anxiety states mentioned in each item according to Likert-type expressions. Trait Anxiety Scale is an assessment scale consisting of 20 items that aims to determine how you feel regardless of your current situation. It asks participants to indicate how often they feel anxiety in their general life. The individual is asked to evaluate how he/she "usually" feels by using the following statements on a 4-point Likert-type scale: (1) "almost never", (2) "sometimes", (3) "a lot of the time", (4) "almost always". asked to choose one
Discharge Readiness Scale
Time frame: It will be applied to patients in both groups the day after surgery.
The scale has a total of eight items and four subscales. The first and second questions measure how the patient feels during the day, the third and fourth questions measure his knowledge about discharge, the fifth and sixth questions measure how and to what extent he can continue his daily life at home after discharge, and the seventh and eighth questions measure the support he can receive at home after he is discharged. The average total score obtained from the scale is considered very ready for discharge between 9-10, very ready for discharge between 8-8.9, moderately ready between 7-7.9, and low ready if below 7.
Physiological Parameters Monitoring Form
Time frame: For the experimental group, before the progressive relaxation exercise and after the progressive relaxation exercise applied at the 6th and 10th hours, for the control group, before the 6th hour without the progressive relaxation exercise, at the 6th and
In the form, patients' systolic and diastolic blood pressure, body temperature, pulse rate, respiratory rate and oxygen saturation are evaluated.
Data Collection Form
Time frame: The Data Collection Form will be filled out at least 1 hour before the surgery.
It was prepared in line with the literature information scanned by the researcher and consists of two parts. In the first part, it is about evaluating the sociodemographic characteristics of the patient; It includes age, education level, height-weight, marital status, profession, working status, chronic diseases, constantly used medications and smoking. In the second part, it is about evaluating the clinical characteristics of the patient; It includes questions evaluating the presence of previous surgery, the duration of the surgery, the presence and type of analgesia administered after the surgery, and the date of hospitalization and discharge.
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 27 Dec 2024.
- Individual participant dataSharing planned: No. I do not want IPD to be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Laparoscopic Cholecystectomy Surgery, run by Bartın Unıversity 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 7 inclusion and 7 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 27 Dec 2024. 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?
Visual Analog Scale- VAS (time frame: For the experimental group, before the progressive relaxation exercise and after the progressive relaxation exercise applied at the 6th and 10th hours, for the control group, before the 6th hour without the progressive relaxation exercise, at the 6th and). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2024.