Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480149
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2024-06-14
Brief Title:
Shoulder Massage After Cholecystectomy
Sponsor:
Maltepe University
Organization:
Maltepe University
Study Overview
Official Title:
The Effect of Shoulder Massage on Shoulder Pain and Sleep Quality in Patients After Laparoscopic Cholecystectomy
Status:
COMPLETED
Status Verified Date:
2024-06
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:
SMALC
Brief Summary:
Purpose The aim of this study is to determine the effect of shoulder massage administered to patients after laparoscopic cholecystectomy on pain and sleep quality
Design The study was designed as a randomized controlled trial Methods This study was carried out with 60 patients who underwent surgery at the General Surgery Department of a universitys Faculty of Medicine between January 2020 and March 2021 The study was completed with 60 patients 30 in the intervention group and 30 in the control group The patients in the intervention group received shoulder massage twice at 6-hour intervals The data for the study were collected using the Individual Introduction Form the Visual Comparison Scale and the Richard Campbell Sleep Scale
Design The study was designed as a randomized controlled trial Methods This study was carried out with 60 patients who underwent surgery at the General Surgery Department of a universitys Faculty of Medicine between January 2020 and March 2021 The study was completed with 60 patients 30 in the intervention group and 30 in the control group The patients in the intervention group received shoulder massage twice at 6-hour intervals The data for the study were collected using the Individual Introduction Form the Visual Comparison Scale and the Richard Campbell Sleep Scale
Detailed Description:
The research population consisted of 132 patients who underwent laparoscopic cholecystectomy surgery at a private university hospital in Istanbul Turkey between January 2020 and March 2021 The sample size was calculated through a power analysis According to the power analysis conducted it was determined that a minimum of 52 individuals with 26 in the experimental group and 26 in the control group were needed to achieve 80 power at a significance level of 005 Considering data losses and after excluding some patients who did not meet the inclusion criteria a total of 60 patients were included in the sample with 30 in the intervention group and 30 in the control group The patients admitted to the hospital were assessed for eligibility by the nurse of the same doctor who would perform this surgery Then the patients were informed about the research by a nurse and asked to volunteer Those who met the eligibility criteria were randomly assigned to either the experimental or control groups using a randomization blocking and coin-flip method with the researcher being informed of the assignments The study was concluded when the desired number of 30 patients in both experimental and control groups was reached using this method
The pain levels of the patients in the intervention group were evaluated by the researcher using the Visual Analog Scale VAS when they regained consciousness approximately one hour after surgery The patients were informed about the massage procedure and placed in the semi-fowler position and olive oil was applied to the hands for lubrication Classical shoulder massage was applied to both shoulders of the patient for 10-15 minutes each 30 minutes after the massage the patients pain was reassessed using the VAS scale Then 6 hours later the patients pain was reassessed and shoulder massage was applied using the same techniques followed by pain assessment 30 minutes later Pharmacologic agents continued to be administered under the guidance of a physician throughout this process
The pain levels of the patients in the intervention group were evaluated by the researcher using the Visual Analog Scale VAS when they regained consciousness approximately one hour after surgery The patients were informed about the massage procedure and placed in the semi-fowler position and olive oil was applied to the hands for lubrication Classical shoulder massage was applied to both shoulders of the patient for 10-15 minutes each 30 minutes after the massage the patients pain was reassessed using the VAS scale Then 6 hours later the patients pain was reassessed and shoulder massage was applied using the same techniques followed by pain assessment 30 minutes later Pharmacologic agents continued to be administered under the guidance of a physician throughout this process
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