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临床试验/NCT07100015
NCT07100015已完成不适用

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

Giresun University2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
2
主要终点
For shoulder pain: Measured with the Visual Analog Scale (VAS).

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: four month

Shoulder Pain Intensity Assessed by Visual Analog Scale (VAS)

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

时间窗: four month

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

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

时间窗: four month

Shoulder Pain Intensity Assessed by Visual Analog Scale (VAS)

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

时间窗: four month

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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