Patient SatisfactionNCT06114524
Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation
A study testing binaural music in people with Patient Satisfaction and Anxiety State, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To investigate the anxiolytic effects of binaural beat-embedded audio in patients undergoing sedation-free upper gastrointestinal endoscopy Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction, Anxiety State, Tolerance
- What is being tested?
- binaural music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 25 Oct 2023
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18-70 years old who had scheduled upper gastrointestinal endoscopy appointments
Who cannot join
- Anxiety and panic disorders
- Urgent endoscopic intervention
- Advanced dementia
- Hearing problems
- Anatomical or inflammatory disorders in the external ear canals
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abdurrahman Yurtaslan Oncology and Training Research Hospital
Ankara, 06200
About this study
To investigate the anxiolytic effects of binaural beat-embedded audio in patients undergoing sedation-free upper gastrointestinal endoscopy
Read the detailed description
The study was conducted with the participation of 96 patients who were referred for endoscopy for various reasons. Data were collected by two researchers. Patients between the ages of 18-70 who had scheduled upper gastrointestinal endoscopy appointments were included in the study, regardless of gender and underlying diseases. Patients who had undergone endoscopic procedures before, were using medication for anxiety and panic disorders, required urgent endoscopic intervention, had advanced dementia, had hearing problems, had anatomical or inflammatory disorders in the external ear canals, and those who did not want to listen to music for 15 minutes before the procedure were not included in the study.
- Conditions
- Patient Satisfaction, Anxiety State, Tolerance
- Being tested
- binaural music
- Medical subject headings
- Patient Satisfaction, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
binaural musicOther
In the binaural music group, an MP3 player and in-ear stereo headphones were provided. Music therapy was applied for 15 min before the procedure.
| Study group | Role | What they receive |
|---|---|---|
| binaural music group | Experimental | Binaural music therapy was applied for 15 min before the procedure. Receives: Other: binaural music |
| control | No intervention | The control group was kept in a quiet room for 15 minutes before the procedure and then taken for the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory (STAI)
Comparative results of the differences in STAI scores before and 5 minutes after the endoscopy in the music and control groups. The State-Trait Anxiety Inventory (STAI) is a valid, self-report measure that consists of 40 items, with 20 items assessing state anxiety (STAI-S) and the other 20 items assessing trait anxiety (STAI-T). For both state and trait components, scores range from 20 to 80, with higher scores indicating higher levels of anxiety
Measured: Within 20 minutes pre-procedure and 5 minutes after the procedure
Secondary outcomes (4)
Patient satisfaction
After the procedure, the patients were asked a series of questions for procedure evaluation (worse than expected, as expected, better than expected) and their willingness to have endoscopy again for their health (no, yes). The binaural music group was asked a three-item question with "yes-not sure-no" responses, inquiring whether the music increased relaxation and if they would like to listen to the same music again during a repeat procedure.
Measured: 5 minutes after the procedure
Heart rate
The comparison of heart rate in the music and control groups
Measured: Within 20 minutes pre-procedure and 5 minutes after the procedure
Blood pressure
The comparison of systolic and diastolic blood pressure in the music and control groups
Measured: Within 20 minutes pre-procedure and 5 minutes after the procedure
patient tolerance
The patient's tolerance during the procedure was assessed by the physician using a scale as follows: 0 (complete tolerance during the procedure, only retching during endoscope insertion); 1 (retching less than 2 times during the procedure); 3 (retching 3 or more times during the procedure); 4 (attempt to remove the endoscope during the procedure).
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start15 Sep 2023
- Primary completion25 Oct 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, selim demirci, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114524
- Sponsor's protocol ID
- Binaural
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Opartpunyasarn P, Vichitvejpaisal P, Oer-Areemitr N. The effect of binaural beat audio on anxiety in patients undergoing fiberoptic bronchoscopy: A prospective randomized controlled trial. Medicine (Baltimore). 2022 Jun 17;101(24):e29392. doi: 10.1097/MD.0000000000029392.
PubMed 35713444Isik BK, Esen A, Buyukerkmen B, Kilinc A, Menziletoglu D. Effectiveness of binaural beats in reducing preoperative dental anxiety. Br J Oral Maxillofac Surg. 2017 Jul;55(6):571-574. doi: 10.1016/j.bjoms.2017.02.014. Epub 2017 Mar 18.
PubMed 28325532Padmanabhan R, Hildreth AJ, Laws D. A prospective, randomised, controlled study examining binaural beat audio and pre-operative anxiety in patients undergoing general anaesthesia for day case surgery. Anaesthesia. 2005 Sep;60(9):874-7. doi: 10.1111/j.1365-2044.2005.04287.x.
PubMed 16115248Demirci S, Sezer S. Effect of Binaural Beats on Anxiety and Tolerance in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation: A Randomized Controlled Trial. J Integr Complement Med. 2024 Dec;30(12):1209-1216. doi: 10.1089/jicm.2023.0804. Epub 2024 Aug 1.
PubMed 39088370
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation
- ClinicalTrials.gov ID
- NCT06114524
- Acronym / sponsor ID
- Binaural
- Conditions
- Patient Satisfaction, Anxiety State, Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 2 Nov 2023 (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.
To investigate the anxiolytic effects of binaural beat-embedded audio in patients undergoing sedation-free upper gastrointestinal endoscopy
Detailed description
The study was conducted with the participation of 96 patients who were referred for endoscopy for various reasons. Data were collected by two researchers. Patients between the ages of 18-70 who had scheduled upper gastrointestinal endoscopy appointments were included in the study, regardless of gender and underlying diseases. Patients who had undergone endoscopic procedures before, were using medication for anxiety and panic disorders, required urgent endoscopic intervention, had advanced dementia, had hearing problems, had anatomical or inflammatory disorders in the external ear canals, and those who did not want to listen to music for 15 minutes before the procedure were not included in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| binaural music group | Experimental | Other: binaural musicBinaural music therapy was applied for 15 min before the procedure. |
| control | No intervention | –The control group was kept in a quiet room for 15 minutes before the procedure and then taken for the procedure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Between 18-70 years old who had scheduled upper gastrointestinal endoscopy appointments
Key exclusion criteria (5 listed)
- Anxiety and panic disorders
- Urgent endoscopic intervention
- Advanced dementia
- Hearing problems
- Anatomical or inflammatory disorders in the external ear canals
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 |
|---|---|---|
| binaural musicIn the binaural music group, an MP3 player and in-ear stereo headphones were provided. Music therapy was applied for 15 min before the procedure. | Other | binaural music group |
Primary outcome
State-Trait Anxiety Inventory (STAI)
Time frame: Within 20 minutes pre-procedure and 5 minutes after the procedure
Comparative results of the differences in STAI scores before and 5 minutes after the endoscopy in the music and control groups. The State-Trait Anxiety Inventory (STAI) is a valid, self-report measure that consists of 40 items, with 20 items assessing state anxiety (STAI-S) and the other 20 items assessing trait anxiety (STAI-T). For both state and trait components, scores range from 20 to 80, with higher scores indicating higher levels of anxiety
4 secondary outcomes
Patient satisfaction
Time frame: 5 minutes after the procedure
Heart rate
Time frame: Within 20 minutes pre-procedure and 5 minutes after the procedure
Blood pressure
Time frame: Within 20 minutes pre-procedure and 5 minutes after the procedure
patient tolerance
Time frame: During the procedure
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 2 Nov 2023.
- Background: PubMed 35713444Opartpunyasarn P, Vichitvejpaisal P, Oer-Areemitr N. The effect of binaural beat audio on anxiety in patients undergoing fiberoptic bronchoscopy: A prospective randomized controlled trial. Medicine (Baltimore). 2022 Jun 17;101(24):e29392. doi: 10.1097/MD.0000000000029392.
- Results publication: PubMed 28325532Isik BK, Esen A, Buyukerkmen B, Kilinc A, Menziletoglu D. Effectiveness of binaural beats in reducing preoperative dental anxiety. Br J Oral Maxillofac Surg. 2017 Jul;55(6):571-574. doi: 10.1016/j.bjoms.2017.02.014. Epub 2017 Mar 18.
- Results publication: PubMed 16115248Padmanabhan R, Hildreth AJ, Laws D. A prospective, randomised, controlled study examining binaural beat audio and pre-operative anxiety in patients undergoing general anaesthesia for day case surgery. Anaesthesia. 2005 Sep;60(9):874-7. doi: 10.1111/j.1365-2044.2005.04287.x.
- Derived from this study: PubMed 39088370Demirci S, Sezer S. Effect of Binaural Beats on Anxiety and Tolerance in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation: A Randomized Controlled Trial. J Integr Complement Med. 2024 Dec;30(12):1209-1216. doi: 10.1089/jicm.2023.0804. Epub 2024 Aug 1.
- Individual participant dataSharing planned: No
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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 binaural music in people with Patient Satisfaction and Anxiety State, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital 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 1 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 2 Nov 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?
State-Trait Anxiety Inventory (STAI) (time frame: Within 20 minutes pre-procedure and 5 minutes after the procedure). 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 NCT06114524, which also lists 4 linked publications.
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 2 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.