PainNCT05850897
The Effect of Foot Massage on Anxiety, Pain and Comfort Level
A study testing Masaj in people with Pain and Anxiety, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Aim and objectives:The aim of this study is to examine the effect of foot massage on reducing pain and anxiety and increasing the comfort level in patients undergoing laparoscopic cholecystectomy. Design:The study is a randomized controlled experimental study with a pretest posttest control group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Masaj
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Who volunteered to participate in the study,
- those who are 18 years of age or older,
- Without communication difficulties and mental disabilities related to vision, hearing and speech,
- Hypertension problem has been controlled,
- Blood pressure measurement does not need to be performed on an outpatient basis,
- Any complications after surgery (bleeding, nausea, vomiting, etc.) that did not occur,
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- Application of cholecystectomy surgery,
- Having a pain assessment score of 4 and above after surgical intervention,
- For patients in the experimental group; infectious disease on the skin, local infection, open lesion/wound, scar tissue, edema,hematoma, thrombophlebitis, deep vein thrombosis, lymphangitis, coagulation disorder, varicose veins, osteoporosis, osteomyelitis, hepatitis, inflammatory and degenerative joint diseases, advanced neuropathy due to diabetes, on the toes deformity, November, who has not recently experienced fractures, dislocations, ruptures of muscle fibers, tendons or fascia,
- Analgesic is not applied before the first attempt, which is planned to be applied after the operation,
- Any medication, etc. without substance abuse,
- No chronic pain in any part of the body,
- All patients who are not pregnant will be included in the sample.
Who cannot join
- Any complications such as severe bleeding, nausea, vomiting develop after surgical intervention.,
- Patient-controlled analgesia (HKA) is applied for pain control after surgical intervention
- Patients who have at least one drain placed at the surgical site are excluded from the sample, as this may affect the level of pain he will be released.
- Termination Criteria: The individual feels uncomfortable during the application or to leave the study if he wants, the work will be terminated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Foot Massage Applied Before and After Cholecystectomy Surgery on Anxiety, Pain and Comfort Level
Aim and objectives:The aim of this study is to examine the effect of foot massage on reducing pain and anxiety and increasing the comfort level in patients undergoing laparoscopic cholecystectomy.
Design:The study is a randomized controlled experimental study with a pretest posttest control group.
Methods:This study will be carried out in Niğde Ömer Halisdemir University Training and Research Hospital General Surgery Clinic. Participants were divided into massage group and control group. Vital signs of the massage group will be taken 2 hours before the operation and Surgical Anxiety Scale will be applied to adult patients (n=40). At this stage, the patient's both feet will be massaged for a total of 20 minutes, 10 minutes each. Vital signs and anxiety status of the patients will be evaluated 30 minutes after the procedure. Postoperative vital signs, pain severity, anxiety and comfort level will be evaluated and after the evaluation, a foot massage will be applied to both feet of the patient for 10 minutes, for a total of 20 minutes. Vital signs and pain levels of the patients will be evaluated at the 5th, 30th, 60th, 90th and 120th minutes after the massage, and their comfort and anxiety levels will be evaluated at the 30th minute. The same data will be collected from patients in the control group (n=40) without foot massage. Data will be collected from Patient Descriptive Information Form, Vital Signs Follow-up Form, Surgical Anxiety Scale for Adult Patients, Perianesthesia Comfort Scale, Numerical Pain Scale.will be used.
Read the detailed description
The study is a randomized controlled experimental study with pre-test post-test control group.The independent variable of the study is foot massage application, the dependent variables are preoperative anxiety level, postoperative pain severity, vital signs (blood pressure, pulse, number of breaths, body temperature, oxygen saturation), anxiety level and comfort level.The research will be conducted at the General Surgery Clinic of Niğde Ömer Halisdemir University Training and Research Hospital.Patients admitted to the General Surgery Clinic for Laparocopic Cholecystectomy surgery after being admitted to the service: The anamnesis form is filled out, the file containing the examinations is prepared,the hunger condition is questioned, the necessary preparations are made for the patient to go to the surgery and the transfer to the operating room is ensured. After the operation; vital signs are checked in postoperative care. The treatment protocol steps are applied in the clinic. Within these steps: I . Usually 2000cc mayi is prepared (LR, 5% Dextrose,0.9% NaCl) II. Antibiotics are administered according to the form specified at the doctor's request (Cefazol or Desefin 2 x 1 V.b.). III. Analgesics are applied according to the patient's condition and the patient's prescription (Oxamen, Tilcotil, Dolantin, Dichlorone, Voltaren, Novalgine) A power analysis was performed to determine the number of people to be included in the research. The strength of the test was calculated with the G*Power 3.1 program. Similar references have been made in the relevant literature. According to the mean and standard deviation values of the Perianesthesia Comfort Scale (PCS) and Numerical Pain Scale (NPS) of the study, the sample size was calculated as 14 people for PPE values and 76 people for PPE values. The study should reach 76 people, including 38 people for each group at the 95% power, 5% significance level and 0.768 effect size. Considering the decrease in the number of patients, it is aimed to recruit a total of 80 people, 40 for each group, to the study.
It was taken by randomization according to the order of arrival in order to avoid bias in the people who will be included in the study.Randomization table "https://www.random.org " it was created using the address. To Investigate the received subjects were matched with the randomization table according to the order of arrival and divided into groups impartially.
Criteria for Inclusion in the Research:
- Who volunteered to participate in the study,
- who is 18 years of age or older,
- Without communication difficulties and mental disabilities related to vision, hearing and speech,
- The hypertension problem has been brought under control,
- Blood pressure measurement does not need to be performed on an outpatient basis,
- Any complications after surgery (bleeding, nausea, vomiting, etc.) that did not occur,
- Performing cholecystectomy surgery,
- Having a pain assessment score of 4 and above after surgical intervention,
- For patients in the experimental group; infectious disease, local infection, open lesion/wound, scar tissue, edema on the skin,hematoma, thrombophlebitis, deep vein thrombosis, lymphangitis, coagulation disorder, varicose veins, osteoporosis, osteomyelitis.
Exclusion Criteria:
After the surgical procedure, severe bleeding, nausea, vomiting, such as any developing complications,
- Patient-controlled analgesia (HKA) is applied for pain control after surgical intervention
- Patients who have at least one drain placed at the surgery site are excluded from the sample, as it may affect the pain level will be released hepatitis, inflammatory and degenerative joint diseases, advanced neuropathy due to diabetes, in the toes who has not experienced deformity, recent fracture, dislocation, rupture of November muscle fiber, tendon or fascia,
- No analgesic applied before the first attempt planned to be applied after surgery,
- Any medicine, etc. non-substance abuse,
- No chronic pain in any area of the body, • All patients who are not pregnant will be included in the scope of the sample
Termination Criteria:
During the application, the individual feels uncomfortable or leaves the study the work will be terminated if requested.
Data Collection Tools:
A two-part Patient Identification Information Form, Life Findings, Follow-up Form, Surgical Anxiety Scale for Adult Patients, Perianesthesia Comfort Scale, and Numerical Pain Scale will be used to collect the data.
Introductory Patient Information Form:
I of this form prepared by the researcher in accordance with the relevant literature.In the section; age, gender, height, weight, educational level, marital status, occupation, smoking and alcohol use and methods of coping with pain, II. In the section, there are questions that question situations such as the location, nature of pain, the use of analgesics.
Collection of Data:
The subjects included in the study were matched with the randomization table according to the order of arrival and divided into intervention and control groups impartially. From these separated groups, the intervention group will be given routine clinical treatment and standard nursing care, as well as foot massage, while the control group will not be given any treatment, routine clinical treatment and standard nursing care will be provided.
Applications to be Made to the Intervention Group:
Foot massage applied to intervention group patients is about this it will be carried out in accordance with the information received in the course by the researcher who has received training and has a certificate.
Vaseline or liquid glycerin recommended by the massage instructor to facilitate hand movements during massage it will be made using. Information about the procedure to patients who meet the criteria for admission to the study on the day of the operation oral and written permissions will be obtained using the Informed Voluntary Consent form. Patient Information Form the scales will be filled in and introduced. Routine treatment applied to the intervention group in the clinic before and after surgery,standard nursing care and foot massage; will be applied. The intervention group's vital signs 2 hours before surgery the findings will be taken and the Surgical Anxiety Scale For Adult Patients will be applied to this group. From the scale evaluation then, foot massage will be applied to each foot for a total of 20 minutes, including 10 minutes.
Vital signs will be taken 30 minutes after the massage application is completed and the anxiety level will be evaluated with the Surgical Anxiety Scale for Adult Patients. The application of postoperative scales and foot massage will be performed 3 hours after the operation, the patients' vital signs will be taken and the pain severity will be evaluated with a Numerical Pain Scale. Simultaneously, the patients' comfort will be evaluated using the Perianesthesia Comfort Level Scale and their anxiety levels will be evaluated using the Surgical Anxiety Scale. After the evaluation, foot massage will be performed on each foot for a total of 20 minutes from 10 minutes. Foot massage will be applied to patients with a pain severity score of 4 and above. After the massage, taking into account the literature information, 5., 30., 60., 90. and 120. the severity of pain in minutes and vital signs it will be evaluated. Anxiety and comfort levels are 30. it will be evaluated per minute. Analgesics applied during discharge and usage amounts will be recorded.
Intervention Group Massage Protocol:
The neck, waist and knee parts of the patients are supported and the semi-fowler or supine position is given to the patients in bed.
- It is necessary for the practitioner to bring the hands to the appropriate temperature by washing them and to apply with short nails.
- The practitioner passes to the patient's feet, bringing the patient's feet to the chest level of the person applying the position is given and eye contact is made with the patient during the application.
- Thumb and finger movements, stroking, rubbing and squeezing movements technique in foot massage application is used. During the adjustment of the pressure intensity, the physical structure of the person, age, etc. characteristics are taken into account. Deep, strong and slow pressure movements in order to relieve and relieve pain, light, fast, progressive pressure movements are stimulating it is applied for the purpose of being. During the application, the active hand applies pressure and the passive hand uses two hands to support the foot the hand is used at the same time.
- The intervention begins by rubbing and warming the feet. After the heating process, first of all, more than one application.it starts with the right foot, which has a nerve end zone and sensitivity, then moves to the left foot.
- The foot heating process time is about 5 minutes, and the foot heating process maneuvers are called "Achilles tendon stretching, wrist relaxation, walking the thumbs of both hands on the sole of the foot and laundry tightening methods are used".
- The pituitary gland and hypothalamus reflex points on the big toe are massaged with caterpillar movement. The same process it is also applied to the other fingers respectively.
- In the form of a worm walk with thumbs from top to bottom and from bottom to top to spinal cord reflex points massage is performed.
- Massage is performed on the intestinal reflex point and adrenal glands reflex points for approximately 3 minutes.
- To the solar plexus area (sympathetic neural networks in the abdominal cavity area to send a warning to the entire body the biggest one) is massaged. Stay in this area by applying a light pressure massage for about 2-3 minutes.
- The inner and outer parts of the foot are patted in a balancing manner. This patting movement on both feet in a light and rhythmic way it is applied and the massage is finished with these movements
Applications to be Made to the Control Group:
The control group that meets the criteria for admission to the study will be informed about the procedure before the surgery on the day of the surgery and oral and written permissions of this group will be obtained using the Informed Voluntary Consent form. The scales will be introduced by filling out the Patient Information Form. The control group vital signs will be taken 2 hours before the operation and Surgical Anxiety Scale For Adult Patients in this group will be applied. No massage application will be performed after the scale evaluation; intervention after waiting until the massage application in the group (a total of 20 minutes) and the rest period (30 minutes), vital the findings will be taken again and the anxiety level will be evaluated with the Surgical Anxiety Scale for Adult Patients. When the patient expresses that he has pain after surgery, the Numerical Pain Scale and the severity of pain with vital signs, anxiety and the comfort level will be evaluated. Waiting for the duration of foot massage performed to the intervention group; 5., 30., 60., 90. and 120. the severity of pain and vital signs will be evaluated in minutes. 30. anxiety and comfort level per minute it will be evaluated. Analgesics applied during discharge and usage amounts will be recorded
- Being tested
- Masaj
- Keywords
- Cholessystectomy, Foot massage, Comfort
- 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.
MasajOther
Appropriate position is given to the patients. Thumb and finger movements, patting, rubbing and squeezing techniques are used in foot massage. During training, the active hand applies pressure, while the passive hand uses both hands to support the foot. The intervention begins with rubbing and warming the feet. The duration of the foot warming process is approximately 5 minutes, and after the foot warming maneuvers, the methods of moving the thumbs of both hands towards the soles of the feet and spinning the laundry are used. The inner and outer parts of the foot are patted in a balanced way. This caressing movement on both feet is done with these movements in a light and rhythmic way and the massage is completed. Data will be obtained with Patient Descriptive Information Form, Vital Signs Follow-up Form, Surgical Anxiety Scale for Adult Patients, Perianesthesia Comfort Scale, Numerical Pain Scale.
| Study group | Role | What they receive |
|---|---|---|
| Massage Group | Experimental | Appropriate position is given to the patients. Thumb and finger movements, patting, rubbing and squeezing techniques are used in foot massage. During training, the active hand applies pressure, while the passive hand uses both hands to support the foot. The intervention begins with rubbing and warming the feet. The duration of the foot warming process is approximately 5 minutes, and after the foot warming maneuvers, the methods of moving the thumbs of both hands towards the soles of the feet and spinning the laundry are used. The inner and outer parts of the foot are patted in a balanced way. This caressing movement on both feet is done with these movements in a light and rhythmic way and the massage is completed. Data will be obtained with Patient Descriptive Information Form, Vital Signs Follow-up Form, Surgical Anxiety Scale for Adult Patients, Perianesthesia Comfort Scale, Numerical Pain Scale. Receives: Other: Masaj |
| Control Group | No intervention | Massage will not be applied to the control group; intervention scales will be applied by taking vital signs after waiting until the massage application in the group (20 minutes in total) and the rest period (30 minutes). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perianesthesia Comfort Scale
PCS consisting of 24 items and before the individual's surgery, it is a 6-point Likert-type scale that questions their general thoughts and feelings about the process during and after. The scale scoring varies between 1 and 6 points Dec, the scale questions are scored as 1= "I Strongly Disagree" 6= "I Strongly Agree".The highest total score of PCS is 144 and the lowest total score is 24.
Measured: Two days
Secondary outcomes (1)
Numerical Pain Scale
This scale, which aims to determine the severity of pain, aims to explain the patient's pain with numbers. It starts with the absence of pain on numerical scales (0) and reaches up to the level of unbearable pain (10).It is preferred due to the fact that it is an understandable and easily applied scale used by researchers at international and national levels to facilitate the identification of patients' pain severity, facilitate scoring and reduce pain.
Measured: Two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start30 Apr 2024
- Primary completion1 Jun 2024
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesibe Sultan ÇINAROĞLU, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850897
- Sponsor's protocol ID
- *SBU,SR,NSBÇ-44*
- Status last verified
- Dec 2024
- First submitted
- 17 Apr 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Massage Applied Before and After Cholecystectomy Surgery on Anxiety, Pain and Comfort Level
- ClinicalTrials.gov ID
- NCT05850897
- Acronym / sponsor ID
- *SBU,SR,NSBÇ-44*
- Keywords
- Cholessystectomy, Foot massage, Comfort
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 9 May 2023 (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.
Aim and objectives:The aim of this study is to examine the effect of foot massage on reducing pain and anxiety and increasing the comfort level in patients undergoing laparoscopic cholecystectomy.
Design:The study is a randomized controlled experimental study with a pretest posttest control group.
Methods:This study will be carried out in Niğde Ömer Halisdemir University Training and Research Hospital General Surgery Clinic. Participants were divided into massage group and control group. Vital signs of the massage group will be taken 2 hours before the operation and Surgical Anxiety Scale will be applied to adult patients (n=40). At this stage, the patient's both feet will be massaged for a total of 20 minutes, 10 minutes each. Vital signs and anxiety status of the patients will be evaluated 30 minutes after the procedure. Postoperative vital signs, pain severity, anxiety and comfort level will be evaluated and after the evaluation, a foot massage will be applied to both feet of the patient for 10 minutes, for a total of 20 minutes. Vital signs and pain levels of the patients will be evaluated at the 5th, 30th, 60th, 90th and 120th minutes after the massage, and their comfort and anxiety levels will be evaluated at the 30th minute. The same data will be collected from patients in the control group (n=40) without foot massage. Data will be collected from Patient Descriptive Information Form, Vital Signs Follow-up Form, Surgical Anxiety Scale for Adult Patients, Perianesthesia Comfort Scale, Numerical Pain Scale.will be used.
Detailed description
The study is a randomized controlled experimental study with pre-test post-test control group.The independent variable of the study is foot massage application, the dependent variables are preoperative anxiety level, postoperative pain severity, vital signs (blood pressure, pulse, number of breaths, body temperature, oxygen saturation), anxiety level and comfort level.The research will be conducted at the General Surgery Clinic of Niğde Ömer Halisdemir University Training and Research Hospital.Patients admitted to the General Surgery Clinic for Laparocopic Cholecystectomy surgery after being admitted to the service: The anamnesis form is filled out, the file containing the examinations is prepared,the hunger condition is questioned, the necessary preparations are made for the patient to go to the surgery and the transfer to the operating room is ensured. After the operation; vital signs are checked in postoperative care. The treatment protocol steps are applied in the clinic. Within these steps: I . Usually 2000cc mayi is prepared (LR, 5% Dextrose,0.9% NaCl) II. Antibiotics are administered according to the form specified at the doctor's request (Cefazol or Desefin 2 x 1 V.b.). III. Analgesics are applied according to the patient's condition and the patient's prescription (Oxamen, Tilcotil, Dolantin, Dichlorone, Voltaren, Novalgine) A power analysis was performed to determine the number of people to be included in the research. The strength of the test was calculated with the G*Power 3.1 program. Similar references have been made in the relevant literature. According to the mean and standard deviation values of the Perianesthesia Comfort Scale (PCS) and Numerical Pain Scale (NPS) of the study, the sample size was calculated as 14 people for PPE values and 76 people for PPE values. The study should reach 76 people, including 38 people for each group at the 95% power, 5% significance level and 0.768 effect size. Considering the decrease in the number of patients, it is aimed to recruit a total of 80 people, 40 for each group, to the study.
It was taken by randomization according to the order of arrival in order to avoid bias in the people who will be included in the study.Randomization table "https://www.random.org " it was created using the address. To Investigate the received subjects were matched with the randomization table according to the order of arrival and divided into groups impartially.
Criteria for Inclusion in the Research:
- Who volunteered to participate in the study,
- who is 18 years of age or older,
- Without communication difficulties and mental disabilities related to vision, hearing and speech,
- The hypertension problem has been brought under control,
- Blood pressure measurement does not need to be performed on an outpatient basis,
- Any complications after surgery (bleeding, nausea, vomiting, etc.) that did not occur,
- Performing cholecystectomy surgery,
- Having a pain assessment score of 4 and above after surgical intervention,
- For patients in the experimental group; infectious disease, local infection, open lesion/wound, scar tissue, edema on the skin,hematoma, thrombophlebitis, deep vein thrombosis, lymphangitis, coagulation disorder, varicose veins, osteoporosis, osteomyelitis.
Exclusion Criteria:
After the surgical procedure, severe bleeding, nausea, vomiting, such as any developing complications,
- Patient-controlled analgesia (HKA) is applied for pain control after surgical intervention
- Patients who have at least one drain placed at the surgery site are excluded from the sample, as it may affect the pain level will be released hepatitis, inflammatory and degenerative joint diseases, advanced neuropathy due to diabetes, in the toes who has not experienced deformity, recent fracture, dislocation, rupture of November muscle fiber, tendon or fascia,
- No analgesic applied before the first attempt planned to be applied after surgery,
- Any medicine, etc. non-substance abuse,
- No chronic pain in any area of the body, • All patients who are not pregnant will be included in the scope of the sample
Termination Criteria:
During the application, the individual feels uncomfortable or leaves the study the work will be terminated if requested.
Data Collection Tools:
A two-part Patient Identification Information Form, Life Findings, Follow-up Form, Surgical Anxiety Scale for Adult Patients, Perianesthesia Comfort Scale, and Numerical Pain Scale will be used to collect the data.
Introductory Patient Information Form:
I of this form prepared by the researcher in accordance with the relevant literature.In the section; age, gender, height, weight, educational level, marital status, occupation, smoking and alcohol use and methods of coping with pain, II. In the section, there are questions that question situations such as the location, nature of pain, the use of analgesics.
Collection of Data:
The subjects included in the study were matched with the randomization table according to the order of arrival and divided into intervention and control groups impartially. From these separated groups, the intervention group will be given routine clinical treatment and standard nursing care, as well as foot massage, while the control group will not be given any treatment, routine clinical treatment and standard nursing care will be provided.
Applications to be Made to the Intervention Group:
Foot massage applied to intervention group patients is about this it will be carried out in accordance with the information received in the course by the researcher who has received training and has a certificate.
Vaseline or liquid glycerin recommended by the massage instructor to facilitate hand movements during massage it will be made using. Information about the procedure to patients who meet the criteria for admission to the study on the day of the operation oral and written permissions will be obtained using the Informed Voluntary Consent form. Patient Information Form the scales will be filled in and introduced. Routine treatment applied to the intervention group in the clinic before and after surgery,standard nursing care and foot massage; will be applied. The intervention group's vital signs 2 hours before surgery the findings will be taken and the Surgical Anxiety Scale For Adult Patients will be applied to this group. From the scale evaluation then, foot massage will be applied to each foot for a total of 20 minutes, including 10 minutes.
Vital signs will be taken 30 minutes after the massage application is completed and the anxiety level will be evaluated with the Surgical Anxiety Scale for Adult Patients. The application of postoperative scales and foot massage will be performed 3 hours after the operation, the patients' vital signs will be taken and the pain severity will be evaluated with a Numerical Pain Scale. Simultaneously, the patients' comfort will be evaluated using the Perianesthesia Comfort Level Scale and their anxiety levels will be evaluated using the Surgical Anxiety Scale. After the evaluation, foot massage will be performed on each foot for a total of 20 minutes from 10 minutes. Foot massage will be applied to patients with a pain severity score of 4 and above. After the massage, taking into account the literature information, 5., 30., 60., 90. and 120. the severity of pain in minutes and vital signs it will be evaluated. Anxiety and comfort levels are 30. it will be evaluated per minute. Analgesics applied during discharge and usage amounts will be recorded.
Intervention Group Massage Protocol:
The neck, waist and knee parts of the patients are supported and the semi-fowler or supine position is given to the patients in bed.
- It is necessary for the practitioner to bring the hands to the appropriate temperature by washing them and to apply with short nails.
- The practitioner passes to the patient's feet, bringing the patient's feet to the chest level of the person applying the position is given and eye contact is made with the patient during the application.
- Thumb and finger movements, stroking, rubbing and squeezing movements technique in foot massage application is used. During the adjustment of the pressure intensity, the physical structure of the person, age, etc. characteristics are taken into account. Deep, strong and slow pressure movements in order to relieve and relieve pain, light, fast, progressive pressure movements are stimulating it is applied for the purpose of being. During the application, the active hand applies pressure and the passive hand uses two hands to support the foot the hand is used at the same time.
- The intervention begins by rubbing and warming the feet. After the heating process, first of all, more than one application.it starts with the right foot, which has a nerve end zone and sensitivity, then moves to the left foot.
- The foot heating process time is about 5 minutes, and the foot heating process maneuvers are called "Achilles tendon stretching, wrist relaxation, walking the thumbs of both hands on the sole of the foot and laundry tightening methods are used".
- The pituitary gland and hypothalamus reflex points on the big toe are massaged with caterpillar movement. The same process it is also applied to the other fingers respectively.
- In the form of a worm walk with thumbs from top to bottom and from bottom to top to spinal cord reflex points massage is performed.
- Massage is performed on the intestinal reflex point and adrenal glands reflex points for approximately 3 minutes.
- To the solar plexus area (sympathetic neural networks in the abdominal cavity area to send a warning to the entire body the biggest one) is massaged. Stay in this area by applying a light pressure massage for about 2-3 minutes.
- The inner and outer parts of the foot are patted in a balancing manner. This patting movement on both feet in a light and rhythmic way it is applied and the massage is finished with these movements
Applications to be Made to the Control Group:
The control group that meets the criteria for admission to the study will be informed about the procedure before the surgery on the day of the surgery and oral and written permissions of this group will be obtained using the Informed Voluntary Consent form. The scales will be introduced by filling out the Patient Information Form. The control group vital signs will be taken 2 hours before the operation and Surgical Anxiety Scale For Adult Patients in this group will be applied. No massage application will be performed after the scale evaluation; intervention after waiting until the massage application in the group (a total of 20 minutes) and the rest period (30 minutes), vital the findings will be taken again and the anxiety level will be evaluated with the Surgical Anxiety Scale for Adult Patients. When the patient expresses that he has pain after surgery, the Numerical Pain Scale and the severity of pain with vital signs, anxiety and the comfort level will be evaluated. Waiting for the duration of foot massage performed to the intervention group; 5., 30., 60., 90. and 120. the severity of pain and vital signs will be evaluated in minutes. 30. anxiety and comfort level per minute it will be evaluated. Analgesics applied during discharge and usage amounts will be recorded
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage Group | Experimental | Other: MasajAppropriate position is given to the patients. Thumb and finger movements, patting, rubbing and squeezing techniques are used in foot massage. During training, the active hand applies pressure, while the passive hand uses both hands to support the foot. The intervention begins with rubbing and warming the feet. The duration of the foot warming process is approximately 5 minutes, and after the foot warming maneuvers, the methods of moving the thumbs of both hands towards the soles of the feet and spinning the laundry are used. The inner and outer parts of the foot are patted in a balanced way. This caressing movement on both feet is done with these movements in a light and rhythmic way and the massage is completed. Data will be obtained with Patient Descriptive Information Form, Vital Signs Follow-up Form, Surgical Anxiety Scale for Adult Patients, Perianesthesia Comfort Scale, Numerical Pain Scale. |
| Control Group | No intervention | –Massage will not be applied to the control group; intervention scales will be applied by taking vital signs after waiting until the massage application in the group (20 minutes in total) and the rest period (30 minutes). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Who volunteered to participate in the study,
- those who are 18 years of age or older,
- Any complications after surgery (bleeding, nausea, vomiting, etc.) that did not occur,
- Any medication, etc. without substance abuse,
- All patients who are not pregnant will be included in the sample.
Key exclusion criteria (4 listed)
- Any complications such as severe bleeding, nausea, vomiting develop after surgical intervention.,
- Patient-controlled analgesia (HKA) is applied for pain control after surgical intervention
- Patients who have at least one drain placed at the surgical site are excluded from the sample, as this may affect the level of pain he will be released.
- Termination Criteria: The individual feels uncomfortable during the application or to leave the study if he wants, the work will be terminated.
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 |
|---|---|---|
| MasajAppropriate position is given to the patients. Thumb and finger movements, patting, rubbing and squeezing techniques are used in foot massage. During training, the active hand applies pressure, while the passive hand uses both hands to support the foot. The intervention begins with rubbing and warming the feet. The duration of the foot warming process is approximately 5 minutes, and after the foot warming maneuvers, the methods of moving the thumbs of both hands towards the soles of the feet and spinning the laundry are used. The inner and outer parts of the foot are patted in a balanced way. This caressing movement on both feet is done with these movements in a light and rhythmic way and the massage is completed. Data will be obtained with Patient Descriptive Information Form, Vital Signs Follow-up Form, Surgical Anxiety Scale for Adult Patients, Perianesthesia Comfort Scale, Numerical Pain Scale. | Other | Massage Group |
Primary outcome
Perianesthesia Comfort Scale
Time frame: Two days
PCS consisting of 24 items and before the individual's surgery, it is a 6-point Likert-type scale that questions their general thoughts and feelings about the process during and after. The scale scoring varies between 1 and 6 points Dec, the scale questions are scored as 1= "I Strongly Disagree" 6= "I Strongly Agree".The highest total score of PCS is 144 and the lowest total score is 24.
1 secondary outcome
Numerical Pain Scale
Time frame: Two days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- 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.
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 Masaj in people with Pain and Anxiety, run by Saglik Bilimleri Universitesi 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 13 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 11 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?
This study is still under way. Results are not available in the source record yet.
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?
Perianesthesia Comfort Scale (time frame: Two days). 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 11 Dec 2024.