Progressive Relaxation Exercises for Kidney Donors

NCT06394245 | Not Yet Recruiting

• 1 other identifier: 2020 (2020/45)
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Transplant; Complications; Muscle Relaxation

Outcome Measures

Primary Outcomes (1)

• Hypothesis

  Performing progressive relaxation exercises after donor nephrectomy will reduce the postoperative VAS pain score in patients.

  Two days

Study Arms (2)

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.

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.

Interventions

Progressive muscle exercises OTHER

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Chronic pain history Patients who developed complications during surgery

Sponsors & Collaborators

• Fenerbahce University: lead

Related Publications (1)

• 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.

  PMID: 40993691 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assit. prof.

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 1, 2024
• Study Start: May 15, 2024
• Primary Completion: May 25, 2024
• Study Completion: June 15, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04