跳至主要内容
临床试验/NCT07328477
NCT07328477已完成不适用

Effect of Box Breathing Technique on Anxiety, Pain, and Nausea in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Randomized Controlled Trial

Acibadem University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年7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
已完成
发起方
入组人数
70
试验地点
1
主要终点
Anxiety level

研究概览

简要总结

This study aims to evaluate the effects of a non-pharmacological breathing technique, known as box breathing, on anxiety, pain, and nausea in adult patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). ERCP is an invasive endoscopic procedure that may cause significant physical and psychological discomfort, including increased anxiety, pain, and nausea.

Participants are randomly assigned to either an intervention group receiving standard care plus box breathing training or a control group receiving standard care alone. The box breathing technique consists of four equal phases of breathing (inhale, hold, exhale, hold), each lasting four seconds. Anxiety, pain, and nausea levels are assessed before ERCP and within the first 24 hours after the procedure. The results of this study may contribute to improving patient comfort and supporting the use of simple, nurse-led interventions in clinical practice.

详细描述

This single-center randomized controlled trial investigates the effectiveness of the box breathing technique on anxiety, pain, and nausea in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). The study is conducted in the gastroenterology clinic of a tertiary care hospital in Turkey.

Adult patients scheduled for ERCP who meet the inclusion criteria are enrolled and randomly assigned to either the intervention group or the control group using simple randomization. Patients in the intervention group receive standard pre-procedural care in addition to structured box breathing training provided by a nurse one day before the ERCP procedure. The box breathing technique involves four equal breathing phases: inhalation for four seconds, breath-holding for four seconds, exhalation for four seconds, and breath-holding again for four seconds. Participants are reminded to practice the technique approximately 30 minutes before the procedure and are encouraged to continue its use after ERCP.

Patients in the control group receive standard care only, without breathing training. Data are collected using validated instruments. Anxiety levels are measured using the State Anxiety Inventory (STAI), pain intensity is assessed using the Visual Analog Scale (VAS), and nausea, vomiting, and retching are evaluated using the Rhodes Index. Baseline measurements are obtained before the procedure, and follow-up assessments are completed within 24 hours after ERCP.

The primary outcome of the study is the change in anxiety levels. Secondary outcomes include pain intensity and nausea severity. This study aims to provide evidence on the effectiveness of a simple, non-invasive, and nurse-led breathing intervention to improve symptom management and patient comfort during invasive endoscopic procedures.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years or older
  • Scheduled to undergo endoscopic retrograde cholangiopancreatography (ERCP)
  • Able to communicate verbally
  • Able to understand and perform the box breathing technique
  • Willing to participate and provide written informed consent

排除标准

  • Cognitive impairment or psychiatric disorders affecting cooperation
  • Hearing or communication problems that prevent understanding instructions
  • Use of sedative or anxiolytic medication before ERCP other than standard sedation
  • Previous participation in breathing or relaxation training programs
  • Emergency ERCP procedures

研究组 & 干预措施

Box Breathing Group

Experimental

Participants receive standard care plus box breathing training before ERCP.

干预措施: Box Breathing Technique (Behavioral)

Control Group

No Intervention

Participants receive standard pre-procedural care only.

结局指标

主要结局

Anxiety level

时间窗: From baseline (before ERCP) to within 24 hours after ERCP

Anxiety level will be assessed using the State Anxiety Inventory (STAI). The scale consists of 20 items, with higher scores indicating higher levels of anxiety.

次要结局

  • Pain intensity(Within 24 hours after ERCP)
  • Nausea severity(Within 24 hours after ERCP)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验