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Completed

NCT Number: NCT07100015

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Giresun Universitesi

Giresun, Piraziz, 28000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control group

Device

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

therapeutic touch

Device

Therapeutic touch applications

Shoulder massage

Device

shoulder massage was applied

Primary outcomes

  1. For shoulder pain: Measured with the Visual Analog Scale (VAS).

    Time frame: four month

    Shoulder Pain Intensity Assessed by Visual Analog Scale (VAS)

  2. For anxiety: The State-Trait Anxiety Inventory (STAI) was used.

    Time frame: four month

    State-Trait Anxiety Inventory (STAI) Score for Anxiety Assessment

Sponsors and collaborators

Lead sponsor

Giresun University

Other

Registry information

Official study title

The Effect of Shoulder Massage and Therapeutic Touch on Pain and Anxiety After Laparoscopic Cholecystectomy: A Three-Arm Single-Blind Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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