Clinical trial NCT06394245: Progressive Relaxation Exercises for Kidney Donors
Official title: Determining the Effect of Progressive Relaxation Exercises on Postoperative Pain in Laparoscopic Living Kidney Donors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Transplant; Complications
Muscle Relaxation
Lead sponsor: Fenerbahce University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hypothesis
timeFrame: Two days
Secondary outcomes:
Other outcomes:
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