Shoulder Massage After Cholecystectomy

NCT06480149 | Completed

• 1 other identifier: 2019/06-8
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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" .

Conditions

Massage; Sleep Quality; Laparoscopic Cholecystectomy; Shoulder Pain

Keywords

Massage; Laparoscopic Cholecystectomy; Sleep Quality; Shoulder Pain

Outcome Measures

Primary Outcomes (2)

• Visual analog scale (VAS)

  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

  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".

Study Arms (2)

SMALC

EXPERIMENTAL

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

control group

OTHER

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

Interventions

SMALC OTHER

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

SMALC

no application OTHER

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

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Maltepe University

Maltepe, Istanbul, 34857, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39232760 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Shoulder Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Senay Ozturk

  Maltepe Univesity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 28, 2024
• Study Start: January 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

TU (1)