Shoulder Massage After Cholecystectomy (SMALC)

June 24, 2024 updated by: Şenay Öztürk, Maltepe University

The Effect of Shoulder Massage on Shoulder Pain and Sleep Quality in Patients After Laparoscopic Cholecystectomy

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" .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İstanbul
      • Maltepe, İstanbul, Turkey, 34857
        • Maltepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMALC
After laparoscopic surgery, the pain levels of the patients were evaluated and appropriate shoulder massage was applied to the patients 2 times at 6 st intervals and the pain levels of the patients were evaluated again. On the morning of the 1st postoperative day, the sleep quality of the patients was evaluated with the Richard Campbell Sleep Scale.
Other: SMALC
Classical shoulder massage was applied to both shoulders of the patient for 10-15 minutes each.
Other: control group
After laparoscopic surgery, the pain levels of the patients were evaluated at the same hours as the intervention group and massage was not applied. On the morning of the 1st postoperative day, the sleep quality of the patients was evaluated with the Richard Campbell Sleep Scale.
Other: no application
In the control group, there was no massage application and only pain and sleep quality were evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale (VAS)
Time Frame: "through study completion, an average of 1 hour".
In this scale developed to determine the severity of pain, patients are able to quantify their pain using numbers. It starts from the absence of pain (0) and goes up to the level of unbearable pain(10). According to the VAS, pain intensity is typically rated as 'no pain' with a score of 0 and 'the worst imaginable pain' with a score of 10 (on a 10 cm scale)
"through study completion, an average of 1 hour".
Richard-Campbell sleep scale
Time Frame: "through study completion, an average of 12 hour".
It is a 6-item scale used to assess the depth of nocturnal sleep, the time to fall asleep, the frequency of awakening, the duration of wakefulness upon awakening, the quality of sleep, and the level of ambient noise. Each item is evaluated on a chart ranging from 0 to 100 using the visual analog scale technique. Scores between "0-25" on the scale indicate very poor sleep quality, while scores between "76-100" indicate very good sleep quality.
"through study completion, an average of 12 hour".

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maltepe University

Investigators

  • Study Director: Senay Ozturk, Maltepe Univesity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/06-8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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