Endoscopic Retrograde CholangiopancreatographyNCT07328477
Box Breathing for Anxiety, Pain and Nausea in ERCP Patients
A study testing Box Breathing Technique in people with Endoscopic Retrograde Cholangiopancreatography and Anxiety, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography, Anxiety, Pain
- What is being tested?
- Box Breathing Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, 34730
About this study
Official title: 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.
Read the 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.
- Conditions
- Endoscopic Retrograde Cholangiopancreatography, Anxiety, Pain, Nausea
- Being tested
- Box Breathing Technique
- Keywords
- Box breathing, Breathing exercises, Non-pharmacological intervention, Nursing intervention, ERCP, Anxiety management, Pain management, Nausea management
- Medical subject headings
- Anxiety Disorders, Pain, Nausea, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Box Breathing TechniqueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Box Breathing Group | Experimental | Participants receive standard care plus box breathing training before ERCP. Receives: Behavioral: Box Breathing Technique |
| Control Group | No intervention | Participants receive standard pre-procedural care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (before ERCP) to within 24 hours after ERCP
Secondary outcomes (2)
Pain intensity
Pain intensity will be measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).
Measured: 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.
Measured: Within 24 hours after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start15 Jul 2025
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Retrograde CholangiopancreatographyStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328477
- Sponsor's protocol ID
- 2025-09-349
- Status last verified
- Jul 2025
- First submitted
- 30 Dec 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Box Breathing Technique on Anxiety, Pain, and Nausea in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07328477
- Acronym / sponsor ID
- 2025-09-349
- Conditions
- Endoscopic Retrograde Cholangiopancreatography, Anxiety, Pain, Nausea
- Keywords
- Box breathing, Breathing exercises, Non-pharmacological intervention, Nursing intervention, ERCP, Anxiety management, Pain management, Nausea management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Box Breathing Group | Experimental | Behavioral: Box Breathing TechniqueParticipants receive standard care plus box breathing training before ERCP. |
| Control Group | No intervention | –Participants receive standard pre-procedural care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Box Breathing TechniqueBox 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. | Behavioural | Box Breathing Group |
Primary outcome
Anxiety level
Time frame: 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.
2 secondary outcomes
Pain intensity
Time frame: Within 24 hours after ERCP
Nausea severity
Time frame: Within 24 hours after ERCP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Box Breathing Technique in people with Endoscopic Retrograde Cholangiopancreatography and Anxiety, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level (time frame: From baseline (before ERCP) to within 24 hours after ERCP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.