The Effect of Shoulder Massage and Therapeutic Touch on Pain and Anxiety After Laparoscopic Cholecystectomy

NCT ID: NCT07100015

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2024-06-01

Brief Summary

This randomized controlled trial compared the effects of shoulder massage and therapeutic touch on pain and anxiety after laparoscopic cholecystectomy. Both interventions significantly reduced pain and anxiety levels compared to the control group. Shoulder massage was more effective in reducing pain, while therapeutic touch was more effective in reducing anxiety. These methods are recommended for broader use in clinical practice.

Detailed Description

Background: Laparoscopic cholecystectomy (LC) is a frequently preferred surgical method for treating gallstones. Non-pharmacologic approaches have an important place in addition to pharmacologic treatment methods. Methods such as massage and therapeutic touch are included in the literature as effective alternatives to reduce pain and anxiety.

Aim: This study aimed to compare the effects of shoulder massage and therapeutic touch on shoulder pain and anxiety after laparoscopic cholecystectomy.

Methods: The study was a three-arm randomized controlled trial. After baseline assessment, participants were randomly assigned to three groups; random assignment was done using the Microsoft Excel 2016 program. Participants were divided into three groups: Group 1 (n=24), in which shoulder massage was applied, Group 2 (n=25), in which therapeutic touch was used, and Group 3 (n=25) in which patients did not receive any treatment and received routine postoperative care in the clinic.

Conditions

Massage Therapy; Pain; Anxiety; Theropathic Touch

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control Group

in which patients did not receive any treatment and received routine postoperative care in the clinic.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: DEVICE

in which patients did not receive any treatment and received routine postoperative care in the clinic

Therapeutic touch

in which therapeutic touch was applied

Group Type: EXPERIMENTAL

therapeutic touch

Intervention Type: DEVICE

Therapeutic touch applications

Shoulder massage group

in which shoulder massage was applied

Group Type: EXPERIMENTAL

Shoulder massage

Intervention Type: DEVICE

shoulder massage was applied

Interventions

Control Group

in which patients did not receive any treatment and received routine postoperative care in the clinic

Intervention Type: DEVICE

therapeutic touch

Therapeutic touch applications

Intervention Type: DEVICE

Shoulder massage

shoulder massage was applied

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Participants were expected to be able to speak Turkish and have normal verbal communication skills.
• They were required to possess normal cognitive abilities and have no psychiatric diagnoses.
• Patients aged between 18 and 70 years.
• Patients undergoing general anesthesia.
• Patients who voluntarily agree to participate in the research

Exclusion Criteria

• Patients receiving epidural analgesia post-surgery.
• Patients whose laparoscopic cholecystectomy (LC) procedure was converted to an open cholecystectomy during the operation.
• Patients experiencing postoperative confusion, requiring intensive care, or developing secondary complications that impair their ability to respond to questions accurately.
• Patients who do not report shoulder pain following surgery.
• Patients in a catabolic state, those aged 70 years or older, individuals with chronic pain or opioid use, and those experiencing severe postoperative symptoms such as excessive nausea, vomiting, bleeding, or infection.
• Patients with surgical drains (e.g., Hemovac) may negatively influence pain levels and sleep quality, thereby interfering with the effectiveness of the intervention.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Giresun University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Giresun Universitesi

Giresun, Piraziz, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SBFGU

Identifier Type: -

Identifier Source: org_study_id