Clinical trial NCT06480149: Shoulder Massage After Cholecystectomy
Official title: The Effect of Shoulder Massage on Shoulder Pain and Sleep Quality in Patients After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Massage
Sleep Quality
Laparoscopic Cholecystectomy
Shoulder Pain
Keywords: Massage
Laparoscopic Cholecystectomy
Sleep Quality
Shoulder Pain
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study included 2 groups, experimental and control. The pain levels of the patients in the intervention group were evaluated one hour after surgery. Classical shoulder massage was applied to both shoulders of the patient for 10-15 minutes each.

Patients in the control group were not massaged, only pain and sleep assessments were performed simultaneously with the intervention group.
Primary purpose: PREVENTION

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 university's 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 0.05. 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 patient's pain was reassessed using the VAS scale. Then, 6 hours later, the patient's 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.

Eligibility criteria: Inclusion Criteria:

* Undergoing general anesthesia,
* Willing to participate in the research

Exclusion Criteria:

* Patients receiving epidural analgesia after surgery
* Patients who underwent a conversion from laparoscopic cholecystectomy to open cholecystectomy during the procedure
* Patients who did not develop shoulder pain after surgery

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: "through study completion, an average of 1 hour".
measure: Richard-Campbell sleep scale
timeFrame: "through study completion, an average of 12 hour".
Secondary outcomes:
Other outcomes:
Locations:
city: Maltepe
country: Turkey
facility: Maltepe University
state: İstanbul
Study officials:
affiliation: Maltepe Univesity
name: Senay Ozturk
role: STUDY_DIRECTOR
References: