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Progressive Relaxation Exercises for Kidney Donors

F

Fenerbahce University

Status

Not yet enrolling

Conditions

Kidney Transplant; Complications
Muscle Relaxation

Treatments

Other: Progressive muscle exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT06394245
2020 (2020/45)

Details and patient eligibility

About

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.

Full 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.

Enrollment

63 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Volunteering to participate in the study Literate and knowing the native language

Exclusion criteria

  • Chronic pain history Patients who developed complications during surgery

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

63 participants in 2 patient groups

Experimental group
Experimental group
Description:
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.
Treatment:
Other: Progressive muscle exercises
Control Group
No Intervention group
Description:
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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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