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Shoulder Massage After Cholecystectomy

NCT ID: NCT06480149

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-03-31

Brief Summary

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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

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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.

Conditions

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Massage Sleep Quality Laparoscopic Cholecystectomy Shoulder Pain

Keywords

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Massage Laparoscopic Cholecystectomy Sleep Quality Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SMALC

Intervention Type OTHER

Classical shoulder massage was applied to both shoulders of the patient for 10-15 minutes each.

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.

Group Type OTHER

no application

Intervention Type OTHER

In the control group, there was no massage application and only pain and sleep quality were evaluated.

Interventions

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SMALC

Classical shoulder massage was applied to both shoulders of the patient for 10-15 minutes each.

Intervention Type OTHER

no application

In the control group, there was no massage application and only pain and sleep quality were evaluated.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maltepe University

OTHER

Sponsor Role lead

Responsible Party

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Şenay Öztürk

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Senay Ozturk

Role: STUDY_DIRECTOR

Maltepe Univesity

Locations

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Maltepe University

Maltepe, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Duran MK, Ozturk S. The effect of shoulder massage on shoulder pain and sleep quality in patients after laparoscopic cholecystectomy: a randomized controlled trial. BMC Nurs. 2024 Sep 4;23(1):618. doi: 10.1186/s12912-024-02264-6.

Reference Type DERIVED
PMID: 39232760 (View on PubMed)

Other Identifiers

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2019/06-8

Identifier Type: -

Identifier Source: org_study_id