Kidney Transplant; ComplicationsNCT06394245
Progressive Relaxation Exercises for Kidney Donors
A study testing Progressive muscle exercises in people with Kidney Transplant; Complications and Muscle Relaxation, run by Fenerbahce University.
Trial summary
Complex emotions and other possible changes associated with agreeing to enroll after laparoscopic donor nephrectomy may cause living donors to experience anxiety, increase in perceived pain temperature, or last longer after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant; Complications, Muscle Relaxation
- What is being tested?
- Progressive muscle exercises
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 15 Jun 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
- Volunteering to participate in the study Literate and knowing the native language
Who cannot join
- Chronic pain history Patients who developed complications during surgery
About this study
Official title: Determining the Effect of Progressive Relaxation Exercises on Postoperative Pain in Laparoscopic Living Kidney Donors
Complex emotions and other possible changes associated with agreeing to enroll after laparoscopic donor nephrectomy may cause living donors to experience anxiety, increase in perceived pain temperature, or last longer after surgery.
Purpose: The purpose of using this method is to determine the effect of progressive relaxation exercises on postoperative pain in laparoscopic living kidney donors.
Method: This randomized controlled single-blind study will conduct with 63 patients (study group = 31, control group = 32) who met the care inclusion criteria and underwent laparoscopic living donor nephrectomy in the transplantation service of a private hospital in Istanbul. The sample size and power of the study were calculated with power analysis (G*Power 3.1). The data will obtain in the study will evaluate in a computer environment through the SPSS 22.0 statistical program. The data of the research will combine with the patient information formula, postoperative patient follow-up and evaluation formula, Visual Pain Scale (VAS), PCA and total demand and delivery of boluses and additional analgesic procedures. This study was conducted in accordance with CONSORT.
Read the detailed description
According to 2021 data, 62% of kidney transplants in the world are performed from cadavers. In Turkey, due to the low number of cadaver organ donations, living kidney transplants are more common (91.17%). Although laparoscopic donor nephrectomy is a minimally invasive technique that offers less pain, better cosmetic results and lower morbidity rates worldwide, living kidney donors experience postoperative pain that hinders postoperative recovery and creates anxiety and fear in some. Lack of direct benefit to the individual, fear of losing the healthy kidney and death after surgery, complex feelings about accepting the transplant, and other possible complications may cause living donors to experience post-operative anxiety, increased perceived pain intensity, or prolonged duration. Furthermore, although acute postoperative pain is an expected outcome after most elective surgeries, including donor nephrectomy, it has been recognized that inadequately treated postoperative acute pain can develop into chronic pain, which is often misdiagnosed and neglected. While this rate was 5.7% after laparoscopic living donor nephrectomy in the study by In one study it was 41% in the study . These conditions may negatively affect the return to normal life and the patients' quality of life. This pain in donors is tried to be managed with opioid and non-opioid medications, social support and ambulation. These efforts have proven challenging, as the subjective nature of pain perception further complicates the ability to achieve satisfactory pain control. Additionally, studies have indicated that certain patient comorbidities and social factors may cause an increase in patients' pain perception.Progressive relaxation exercise (PGE) is a type of exercise that provides tension and relaxation of a large muscle group, developed 1920. In the literature, it is stated that PGE application makes it easier for the individual to cope with pain due to reasons such as reducing muscle tension, anxiety and stress effects, reducing blood pressure, heart rate, lactic acid production, increasing concentration and positive thoughts by regulating the activity of the nervous system, suppressing negative thoughts, and diverting attention. stated. When we look at the literature, there are almost no studies discussing non-pharmacological methods to prevent or reduce pain in donors, which is thought to be mostly psychosomatic. RCTs using standardized relaxation protocols are needed to provide further evidence on this topic. In the light of this information, the aim of this study is to determine the effect of progressive relaxation exercises on postoperative pain in laparoscopic living kidney donors.
- Being tested
- Progressive muscle exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive muscle exercisesOther
The initiative was made with the Turkish Psychologists Association's Progressive Relaxation Exercises audio recorded. PGE consists of a recording of breathing exercises and progressive muscle stretching exercises, with music in the background that will relax the patient. The first part of the recordings takes approximately 10 minutes. It continues and includes information about the definition of relaxation exercise, its purpose, benefits and points to consider when starting the exercises, correct breathing in the appropriate position and what the environment should be like. The second part consists of how to contract and relax certain muscles in our body, which takes approximately 25-30 minutes, and the steps to exit this process after the relaxation session is over.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | All sampled patients will administer STAI-1 and then VAS before relaxation exercises. Pain levels will be evaluated by applying VAS again. VAS and STAI will applie again to all patients at discharge. 400 mg contramol in 100 cc SF at 5cc/hour continues on the first day after surgery by PCA (Patient control analgezia). The total number of boluse administrations and additional analgesic requirements of the patients will record by PCA after the application during the day. After the implementation of the PMR exercise protocol, no side effects or signs of discomfort will observe in the patients. In the hospital where the study will conduct, if patients can tolerate it, they are routinely mobilized for 8 hours after surgery and are fed there 6 hours later. Patients in the experimental and control groups will evaluate in terms of postoperative mobilization and oral feeding initiation times. Receives: Other: Progressive muscle exercises |
| Control Group | No intervention | Patients in the control group will not receive any special intervention, only routine care. After data will collect from the patients in the control group, they will be informed that they can do progressive muscle relaxation exercises whenever they want. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothesis
Performing progressive relaxation exercises after donor nephrectomy will reduce the postoperative VAS pain score in patients.
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 posted1 May 2024
- Study start15 May 2024 (estimated)
- Primary completion25 May 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
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 Kidney Transplant; ComplicationsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ogr. Uyesi Naile, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394245
- Sponsor's protocol ID
- 2020 (2020/45)
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akinci N. Effect of progressive muscle relaxation on postoperative pain in laparoscopic living kidney donors: a randomized controlled trial. BMC Surg. 2025 Sep 24;25(1):410. doi: 10.1186/s12893-025-03187-y.
PubMed 40993691
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Progressive Relaxation Exercises on Postoperative Pain in Laparoscopic Living Kidney Donors
- ClinicalTrials.gov ID
- NCT06394245
- Acronym / sponsor ID
- 2020 (2020/45)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 25 May 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 1 May 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.
Complex emotions and other possible changes associated with agreeing to enroll after laparoscopic donor nephrectomy may cause living donors to experience anxiety, increase in perceived pain temperature, or last longer after surgery.
Purpose: The purpose of using this method is to determine the effect of progressive relaxation exercises on postoperative pain in laparoscopic living kidney donors.
Method: This randomized controlled single-blind study will conduct with 63 patients (study group = 31, control group = 32) who met the care inclusion criteria and underwent laparoscopic living donor nephrectomy in the transplantation service of a private hospital in Istanbul. The sample size and power of the study were calculated with power analysis (G*Power 3.1). The data will obtain in the study will evaluate in a computer environment through the SPSS 22.0 statistical program. The data of the research will combine with the patient information formula, postoperative patient follow-up and evaluation formula, Visual Pain Scale (VAS), PCA and total demand and delivery of boluses and additional analgesic procedures. This study was conducted in accordance with CONSORT.
Detailed description
According to 2021 data, 62% of kidney transplants in the world are performed from cadavers. In Turkey, due to the low number of cadaver organ donations, living kidney transplants are more common (91.17%). Although laparoscopic donor nephrectomy is a minimally invasive technique that offers less pain, better cosmetic results and lower morbidity rates worldwide, living kidney donors experience postoperative pain that hinders postoperative recovery and creates anxiety and fear in some. Lack of direct benefit to the individual, fear of losing the healthy kidney and death after surgery, complex feelings about accepting the transplant, and other possible complications may cause living donors to experience post-operative anxiety, increased perceived pain intensity, or prolonged duration. Furthermore, although acute postoperative pain is an expected outcome after most elective surgeries, including donor nephrectomy, it has been recognized that inadequately treated postoperative acute pain can develop into chronic pain, which is often misdiagnosed and neglected. While this rate was 5.7% after laparoscopic living donor nephrectomy in the study by In one study it was 41% in the study . These conditions may negatively affect the return to normal life and the patients' quality of life. This pain in donors is tried to be managed with opioid and non-opioid medications, social support and ambulation. These efforts have proven challenging, as the subjective nature of pain perception further complicates the ability to achieve satisfactory pain control. Additionally, studies have indicated that certain patient comorbidities and social factors may cause an increase in patients' pain perception.Progressive relaxation exercise (PGE) is a type of exercise that provides tension and relaxation of a large muscle group, developed 1920. In the literature, it is stated that PGE application makes it easier for the individual to cope with pain due to reasons such as reducing muscle tension, anxiety and stress effects, reducing blood pressure, heart rate, lactic acid production, increasing concentration and positive thoughts by regulating the activity of the nervous system, suppressing negative thoughts, and diverting attention. stated. When we look at the literature, there are almost no studies discussing non-pharmacological methods to prevent or reduce pain in donors, which is thought to be mostly psychosomatic. RCTs using standardized relaxation protocols are needed to provide further evidence on this topic. In the light of this information, the aim of this study is to determine the effect of progressive relaxation exercises on postoperative pain in laparoscopic living kidney donors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Progressive muscle exercisesAll sampled patients will administer STAI-1 and then VAS before relaxation exercises. Pain levels will be evaluated by applying VAS again. VAS and STAI will applie again to all patients at discharge. 400 mg contramol in 100 cc SF at 5cc/hour continues on the first day after surgery by PCA (Patient control analgezia). The total number of boluse administrations and additional analgesic requirements of the patients will record by PCA after the application during the day. After the implementation of the PMR exercise protocol, no side effects or signs of discomfort will observe in the patients. In the hospital where the study will conduct, if patients can tolerate it, they are routinely mobilized for 8 hours after surgery and are fed there 6 hours later. Patients in the experimental and control groups will evaluate in terms of postoperative mobilization and oral feeding initiation times. |
| Control Group | No intervention | –Patients in the control group will not receive any special intervention, only routine care. After data will collect from the patients in the control group, they will be informed that they can do progressive muscle relaxation exercises whenever they want. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteering to participate in the study Literate and knowing the native language
Key exclusion criteria (1 listed)
- Chronic pain history Patients who developed complications during 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 muscle exercisesThe initiative was made with the Turkish Psychologists Association's Progressive Relaxation Exercises audio recorded. PGE consists of a recording of breathing exercises and progressive muscle stretching exercises, with music in the background that will relax the patient. The first part of the recordings takes approximately 10 minutes. It continues and includes information about the definition of relaxation exercise, its purpose, benefits and points to consider when starting the exercises, correct breathing in the appropriate position and what the environment should be like. The second part consists of how to contract and relax certain muscles in our body, which takes approximately 25-30 minutes, and the steps to exit this process after the relaxation session is over. | Other | Experimental group |
Primary outcome
Hypothesis
Time frame: Two days
Performing progressive relaxation exercises after donor nephrectomy will reduce the postoperative VAS pain score in patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Derived from this study: PubMed 40993691Akinci N. Effect of progressive muscle relaxation on postoperative pain in laparoscopic living kidney donors: a randomized controlled trial. BMC Surg. 2025 Sep 24;25(1):410. doi: 10.1186/s12893-025-03187-y.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive muscle exercises in people with Kidney Transplant; Complications and Muscle Relaxation, run by Fenerbahce University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Hypothesis (time frame: Two days). 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 NCT06394245, 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 May 2024.