Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394245
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-25
Brief Title:
Progressive Relaxation Exercises for Kidney Donors
Sponsor:
Fenerbahce University
Organization:
Fenerbahce University
Study Overview
Official Title:
Determining the Effect of Progressive Relaxation Exercises on Postoperative Pain in Laparoscopic Living Kidney Donors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 GPower 31 The data will obtain in the study will evaluate in a computer environment through the SPSS 220 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
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 GPower 31 The data will obtain in the study will evaluate in a computer environment through the SPSS 220 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 9117 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 57 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 perceptionProgressive 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None