Box Breathing for Anxiety, Pain and Nausea in ERCP Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Nausea; Anxiety; Endoscopic Retrograde Cholangiopancreatography
• Intervention / Treatment: Behavioral: Box Breathing Technique

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34730
    • Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Box Breathing Group; Participants receive standard care plus box breathing training before ERCP.	Behavioral: Box Breathing Technique; Box breathing is a structured breathing technique consisting of four equal phases: inhalation for four seconds, breath holding for four seconds, exhalation for four seconds, and breath holding again for four seconds. The technique is taught by a nurse one day before ERCP and practiced approximately 30 minutes before the procedure.
No Intervention: Control Group; Participants receive standard pre-procedural care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety level	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.	From baseline (before ERCP) to within 24 hours after ERCP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity will be measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).	Within 24 hours after ERCP
Nausea severity	Nausea, vomiting, and retching will be evaluated using the Rhodes Index of Nausea, Vomiting, and Retching (INVR). Higher scores indicate greater symptom severity.	Within 24 hours after ERCP

Collaborators and Investigators

• Sponsor: Acibadem University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Actual): March 30, 2026
• Study Completion (Actual): March 30, 2026

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Pain management; ERCP; Breathing exercises; Non-pharmacological intervention; Nursing intervention; Anxiety management; Box breathing; Nausea management
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Signs and Symptoms, Digestive; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders; Nausea; Agnosia
• Other Study ID Numbers: 2025-09-349

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the study is a single-center academic study and the informed consent obtained from participants did not include provisions for data sharing beyond the research team. Data are stored securely and will be used only for the purposes defined in the study protocol.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No