Box breathing to reduce anxiety, pain, and nausea during ERCP
Effect of Box Breathing Technique on Anxiety, Pain, and Nausea in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Randomized Controlled Trial
NA · Acibadem University · NCT07328477
This trial tests whether a short nurse-led box breathing exercise can lower anxiety, pain, and nausea in adults having ERCP.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Acibadem University (other) |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07328477 on ClinicalTrials.gov |
What this trial studies
This single-center randomized controlled trial in Turkey assigns adults scheduled for ERCP to standard care with or without nurse-led box breathing training provided one day before the procedure. The box breathing technique uses four equal phases (inhale, hold, exhale, hold) of about four seconds each, and participants are reminded to practice roughly 30 minutes before ERCP and encouraged to continue afterward. Anxiety, pain, and nausea are measured before the procedure and within 24 hours after ERCP using the State Anxiety Inventory (STAI), Visual Analog Scale (VAS), and Rhodes Index. The trial is designed to see if this simple, non-pharmacological nursing intervention improves patient comfort around ERCP.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for non-emergency ERCP who can understand and perform the breathing technique, communicate verbally, and provide informed consent are the intended participants.
Not a fit: Patients with cognitive or communication impairments, those using sedative or anxiolytic medications outside standard sedation, prior formal breathing/relaxation training, or undergoing emergency ERCP may not benefit or be eligible.
Why it matters
Potential benefit: If effective, the technique could offer a low-cost, easy way to reduce anxiety, pain, and nausea and improve comfort for patients undergoing ERCP.
How similar studies have performed: Breathing and relaxation techniques have shown benefits for procedural anxiety and pain in other clinical settings, but applying structured box breathing specifically to ERCP is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Istanbul
- Goztepe Prof. Dr. Suleyman Yalcin City Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Nermin Ocaktan, PhD
- Email: nermin.ocaktan@acibadem.edu.tr
- Phone: +905337373306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endoscopic Retrograde Cholangiopancreatography, Anxiety, Pain, Nausea, Box breathing, Breathing exercises, Non-pharmacological intervention, Nursing intervention