Box Breathing for Anxiety, Pain and Nausea in ERCP Patients

NCT07328477 | Recruiting

• 1 other identifier: 2025-09-349
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Pain; Nausea; Endoscopic Retrograde Cholangiopancreatography

Keywords

Box breathing; Breathing exercises; Non-pharmacological intervention; Nursing intervention; ERCP; Anxiety management; Pain management; Nausea management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain intensity

  Within 24 hours after ERCP

• Nausea severity

  Within 24 hours after ERCP

Study Arms (2)

Box Breathing Group

EXPERIMENTAL

Participants receive standard care plus box breathing training before ERCP.

Behavioral: Box Breathing Technique

Control Group

NO INTERVENTION

Participants receive standard pre-procedural care only.

Interventions

Box Breathing Technique BEHAVIORAL

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.

Box Breathing Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, 34730, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain; Nausea; Agnosia

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Nermin Ocaktan, PhD

CONTACT

+905337373306; nermin.ocaktan@acibadem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized into two parallel groups: an intervention group receiving box breathing in addition to standard care, and a control group receiving standard care alone.

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 9, 2026
• Study Start: September 15, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)