Endoscopic Retrograde Cholangio-PancreatographyNCT04641052
The Effects Of Music In Endoscopic Retrograde Cholangiopancreatography Procedure
A study testing Music listening in people with Endoscopic Retrograde Cholangio-Pancreatography and Anxiety, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effect of music listening on patients who will have Endoscopic Retrograde Cholangio-Pancreatography Procedure on vital signs, anxiety, and pain. This will be a randomized controlled experimental study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Retrograde Cholangio-Pancreatography, Anxiety, Pain
- What is being tested?
- Music listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Nov 2020to 11 Feb 2021
- 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
- patients aged 18 or above,
- with a scheduled ERCP procedure
- with the ASA grade level of I-II clinically
- without a hearing/speech impairment
- willing to participate in the research
- without a mental problem or diagnosis of psychiatric disorder
- without any a diagnosis of depression
Who cannot join
- Patients with an emergency ERCP procedure
- with a hearing/speech impairment
- not willing to participate in the research
- with a mental problem or diagnosis of psychiatric disorder
- with a diagnosis of depression
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences university Hospital
Afyonkarahisar
About this study
Official title: Effects of Music Intervention on Pain, Anxiety and Vital Signs in Patients With Endoscopic Retrograde Cholangiopancreatography
This study aims to investigate the effect of music listening on patients who will have Endoscopic Retrograde Cholangio-Pancreatography Procedure on vital signs, anxiety, and pain. This will be a randomized controlled experimental study.
The study will be conducted with two groups: the intervention group (n=35) and the control group (n=35). The control group will receive standard care while the intervention group, in addition to standard care, will be listened to music by the researchers for 15 minutes before the procedure.
- Being tested
- Music listening
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music listeningOther
The music type will be chosen by the patients and researchers will not have any influence on their choices.
| Study group | Role | What they receive |
|---|---|---|
| Music Intervention Group | Experimental | The music intervention group will be listened to the music by the researchers for the duration of 15 minutes before the procedure as well as the standard care. Receives: Other: Music listening |
| No Intervention Group | No intervention | The control group patients will receive standard care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale for Anxiety (VAS-A)
VAS-A is a 10 cm long measuring instrument with the score range from 0 to 10 with 0 points showing "no anxiety" and 10 points showing "I feel a lot of anxiety"
Measured: 1 Hour
Visual Analog Scale for Pain (VAS)
VAS scale is a single-dimensional scale that is commonly used to evaluate pain severity. According to VAS, pain intensity is rated as "no pain" with 0 points, and "the most severe pain imaginable" with 10 points. Pain intensity ranges were determined by VAS as follows; mild pain below 3 points, as moderate pain between 3 and 6 points, and as severe pain above 6 points.The VAS pain scale was applied to the patients once on the first postoperative day, for the level of pain they felt.
Measured: 2 Hours
Secondary outcomes (3)
Vital Signs
The systolic and diastolic blood pressure will be measured with " MICROLIFE BP A 150 AFIB" device by the researchers.
Measured: 4 Hours
Vital Signs
Heart rate values of the patients will be measured with a finger type oximeter by the researchers.
Measured: 4 hours
Vital Signs
SpO2 values of the patients will be measured with a finger type oximeter by the researchers.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start24 Nov 2020
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Retrograde Cholangio-PancreatographyStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Ciğerci, Afyonkarahisar Health Sciences University
- Investigators
- Yeliz CIGERCI, Phd, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641052
- Sponsor's protocol ID
- 2020\481
- Status last verified
- Dec 2022
- First submitted
- 17 Nov 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cakir E, Cigerci Y, Yilmaz S. Impact of music intervention on endoscopic retrograde cholangiopancreatography patients' pain, anxiety, and vital signs: a randomized controlled trial. Sci Rep. 2026 May 21;16(1):24261. doi: 10.1038/s41598-026-50809-3.
PubMed 42168374
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music Intervention on Pain, Anxiety and Vital Signs in Patients With Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT04641052
- Acronym / sponsor ID
- 2020\481
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 23 Nov 2020 (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 investigate the effect of music listening on patients who will have Endoscopic Retrograde Cholangio-Pancreatography Procedure on vital signs, anxiety, and pain. This will be a randomized controlled experimental study.
The study will be conducted with two groups: the intervention group (n=35) and the control group (n=35). The control group will receive standard care while the intervention group, in addition to standard care, will be listened to music by the researchers for 15 minutes before the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Intervention Group | Experimental | Other: Music listeningThe music intervention group will be listened to the music by the researchers for the duration of 15 minutes before the procedure as well as the standard care. |
| No Intervention Group | No intervention | –The control group patients will receive standard care only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients aged 18 or above,
- with a scheduled ERCP procedure
- with the ASA grade level of I-II clinically
- without a hearing/speech impairment
- willing to participate in the research
Key exclusion criteria (5 listed)
- Patients with an emergency ERCP procedure
- with a hearing/speech impairment
- not willing to participate in the research
- with a mental problem or diagnosis of psychiatric disorder
- with a diagnosis of depression
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 |
|---|---|---|
| Music listeningThe music type will be chosen by the patients and researchers will not have any influence on their choices. | Other | Music Intervention Group |
Primary outcome
Visual Analog Scale for Anxiety (VAS-A)
Time frame: 1 Hour
VAS-A is a 10 cm long measuring instrument with the score range from 0 to 10 with 0 points showing "no anxiety" and 10 points showing "I feel a lot of anxiety"
Visual Analog Scale for Pain (VAS)
Time frame: 2 Hours
VAS scale is a single-dimensional scale that is commonly used to evaluate pain severity. According to VAS, pain intensity is rated as "no pain" with 0 points, and "the most severe pain imaginable" with 10 points. Pain intensity ranges were determined by VAS as follows; mild pain below 3 points, as moderate pain between 3 and 6 points, and as severe pain above 6 points.The VAS pain scale was applied to the patients once on the first postoperative day, for the level of pain they felt.
3 secondary outcomes
Vital Signs
Time frame: 4 Hours
Vital Signs
Time frame: 4 hours
Vital Signs
Time frame: 4 hours
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 4 Jan 2023.
- Derived from this study: PubMed 42168374Cakir E, Cigerci Y, Yilmaz S. Impact of music intervention on endoscopic retrograde cholangiopancreatography patients' pain, anxiety, and vital signs: a randomized controlled trial. Sci Rep. 2026 May 21;16(1):24261. doi: 10.1038/s41598-026-50809-3.
- Individual participant dataSharing planned: No
Related trials for Endoscopic Retrograde Cholangio-Pancreatography
Recruiting
Evaluation of the Benefit of Lidocaine on the Prevention of the Risk of Post Endoscopic Retrograde Cholangio-pancreatography Pancreatitis.
ERCP Surgery
RecruitingObservational study
Prospective Validation of the SWEET Tool for Pre-diction of Preintervention ERCP Procedure Time.
Endoscopic Retrograde Cholangio-Pancreatography
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.
Yeliz CIGERCI, Phd principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music listening in people with Endoscopic Retrograde Cholangio-Pancreatography and Anxiety, run by Afyonkarahisar Health Sciences 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 7 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 4 Jan 2023. 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?
Visual Analog Scale for Anxiety (VAS-A) (time frame: 1 Hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04641052, which also lists 1 linked publication.
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 4 Jan 2023.