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临床试验/NCT07327957
NCT07327957进行中(未招募)不适用

The Effect of Vibration and Breathing Exercises Applied Before Chest Tube Removal on Pain and Anxiety: A Randomized Controlled Trial

Gamze BULUT1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
90
试验地点
1
主要终点
Pain Intensity

研究概览

简要总结

Removing a chest tube is a common procedure after chest surgery, but it can cause significant pain and anxiety for patients. Although medications can help reduce these symptoms, they may have side effects and are not always sufficient. Therefore, simple and safe non-drug methods are increasingly used to improve patient comfort.

This randomized controlled study aims to examine the effects of vibration and breathing exercises applied before chest tube removal on patients' pain and anxiety levels. Adult patients with a chest tube will be randomly assigned to one of three groups: a vibration group, a breathing exercise group, or a control group receiving standard care. Pain and anxiety levels will be measured before the procedure and after chest tube removal using validated scales.

The findings of this study are expected to show whether vibration and breathing exercises are effective in reducing pain and anxiety during chest tube removal. If effective, these methods may offer nurses an easy, low-cost, and safe way to improve patient comfort and support evidence-based nursing care.

详细描述

Chest tube removal is a necessary clinical procedure following thoracic surgery, but it is frequently associated with acute pain and heightened anxiety. These symptoms may negatively affect patient comfort, cooperation, and recovery. While pharmacological interventions are commonly used to manage procedure-related pain and anxiety, concerns regarding side effects and limited effectiveness have increased interest in non-pharmacological approaches within nursing care.

This randomized controlled study is designed to evaluate the effectiveness of vibration and breathing exercises applied prior to chest tube removal on pain and anxiety levels. Eligible adult patients hospitalized in a thoracic surgery unit and scheduled for chest tube removal will be randomly assigned to one of three groups: a vibration group, a breathing exercise group, or a control group receiving routine care. Randomization will be performed using a web-based randomization tool to ensure equal allocation.

In the vibration group, a portable vibration device will be applied to the area proximal to the chest tube insertion site for a standardized duration before the removal procedure. In the breathing exercise group, participants will be guided through structured breathing exercises designed to promote relaxation and diaphragmatic breathing. The control group will receive standard clinical care without any additional non-pharmacological intervention.

Pain intensity and anxiety levels will be assessed at two time points: prior to the chest tube removal procedure and shortly after the procedure. Validated measurement tools will be used to ensure reliability of the findings. Data will be analyzed to compare changes in pain and anxiety levels within and between groups.

The results of this study are expected to provide evidence regarding the use of vibration and breathing exercises as simple, safe, and cost-effective nursing interventions to reduce pain and anxiety associated with chest tube removal. These findings may contribute to the development of evidence-based, non-pharmacological strategies in clinical nursing practice.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age and older,
  • Conscious, oriented, and cooperative (e.g., Glasgow Coma Score ≥ 13),
  • Able to speak and understand Turkish,
  • Having a chest tube and undergoing chest tube removal for the first time,
  • Hemodynamically stable,
  • Having not taken analgesic, sedative, or anxiolytic drugs at least 4 hours prior to the procedure,
  • Able to communicate and respond to pain assessment scales during the procedure,
  • No severe hearing, visual, or communication impairment,
  • No neurological or cognitive disease that could affect the assessment of cognitive functions,
  • No history of psychiatric diagnosis or active psychiatric treatment,
  • Patients who voluntarily participate in the study and provide written consent will be included.

排除标准

  • Patients with past or current cognitive and psychological disorders,
  • Those who have previously had chest tube insertion,
  • Those who are mechanically ventilated (intubated),
  • Those who have chronic pain and routinely use analgesics,
  • Those who used analgesics immediately before chest tube removal,
  • Those who did not volunteer to participate in the study.

研究组 & 干预措施

Control Group (Standard Care)

No Intervention

Participants in the control group will receive routine clinical care according to standard hospital protocols prior to chest tube removal. No additional non-pharmacological interventions, including vibration or breathing exercises, will be applied before the procedure.

Vibration

Experimental

Participants in this group will receive a non-pharmacological intervention consisting of vibration before chest tube removal. Vibration will be applied proximal to the chest tube insertion site for a standard duration using a portable vibrating device. The interventions will be performed in addition to routine clinical care.

干预措施: Vibration (Other)

Breathing Exercise Group

Experimental

Individuals in the breathing exercise group will be led through breathing exercises by the researcher in their room before the procedure begins. The exercise duration is approximately 8-10 minutes. The environment should be quiet, at room temperature, and well-ventilated during the exercises. The patient should be seated in a comfortable position, and the following steps will be followed.

干预措施: Breathing Exercises (Other)

结局指标

主要结局

Pain Intensity

时间窗: Assessed immediately before chest tube removal and 10 minutes after the procedure.

Pain intensity associated with chest tube removal will be assessed using the Visual Analog Scale (VAS), a validated 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will self-report their pain level.

次要结局

  • Anxiety Level(Assessed immediately before chest tube removal and 10 minutes after the procedure.)

研究者

发起方
Gamze BULUT
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gamze BULUT

Research Assistant, Department of Surgical Nursing

Ataturk University

研究点 (1)

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