Anxiety StateNCT06187233
The Effects of Binaural Beats on Pain, Anxiety, and Procedure Tolerance in Patients Undergoing Colonoscopy Without Sedation
A study testing binaural music in people with Anxiety State and Patient Satisfaction, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to investigate the effect of binaural beats on anxiety, pain and tolerance during colonoscopy without sedation Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety State, Patient Satisfaction, Tolerance
- What is being tested?
- binaural music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 30 Nov 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 colonoscopy 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
The purpose of this study was to investigate the effect of binaural beats on anxiety, pain and tolerance during colonoscopy without sedation
Read the detailed description
It is a prospective randomized, controlled, single-blind procedural study included 92 Turkish patients aged 18-70 years old scheduled for colonoscopy regardless of sex or underlying disease. The patients were randomly divided into two groups: the binaural beat music group(n=46) and the control group(n=46). The binaural music group listened to music through headphones during colonoscopy, while the control group had headphones without music. Anxiety levels (VAS-Anxiety scale) were measured both before and after the procedure, and pain levels (VAS-pain) were measured following the procedure. Hemodynamic changes before and after endoscopy , procedure tolerance (using modified gloucester comfort scale), cecal insertion and withdrawal times, polyp detection rate, and patients' experiences related to colonoscopy were recorded. Likert scales were collected as well just after the colonoscopy procedure, indicating satisfaction and willingness to repeat the process.
- Conditions
- Anxiety State, Patient Satisfaction, Tolerance
- Being tested
- binaural music
- Medical subject headings
- Anxiety Disorders, Patient Satisfaction
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 during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| binaural music group | Experimental | The music group listened to music containing binaural beats during the colonoscopy Receives: Other: binaural music |
| control | No intervention | The control group had headphones without sound during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS-anxiety
The VAS scale, developed by Price et al. (1983), has been employed in recent years to measure patients' subjective experiences of pain and anxiety.This scale utilizes a 10-cm horizontal or vertical line, with the two endpoints representing the minimum and maximum scores for pain and anxiety(0: no pain/no anxiety, 10: the most severe pain/extremely anxious). The colonoscopy nurse recorded patients' pain and anxiety scores by manually marking a 10-cm line. This indicator is a reliable measure for assessing pain and anxiety
Measured: immediately before being taken into the procedure room and 5 minutes after the procedure
VAS-pain
The VAS scale, developed by Price et al. (1983), has been employed in recent years to measure patients' subjective experiences of pain and anxiety.This scale utilizes a 10-cm horizontal or vertical line, with the two endpoints representing the minimum and maximum scores for pain and anxiety(0: no pain/no anxiety, 10: the most severe pain/extremely anxious). The colonoscopy nurse recorded patients' pain and anxiety scores by manually marking a 10-cm line. This indicator is a reliable measure for assessing pain and anxiety
Measured: 5 minutes after the procedure
The Modified Gloucester Comfort Scale
The endoscopy nurse recorded and analyzed data related to patient comfort, encompassing compliance and tolerance during the procedure, using the Modified Gloucester Comfort Scale.Discomfort, characterized by severe belching, retching, coughing, and non-compliance, was assessed on a scale where the absence of discomfort received a score of 1 point, while extreme discomfort during the procedure was assigned 5 points.
Measured: During the procedure
Secondary outcomes (6)
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
cecal insertion time(minutes)
Insertion time, as defined, refers to the duration between the initiation of the colonoscopy procedure and the moment when the endoscope reaches the cecum, with identification of the appendiceal orifice.
Measured: during the procedure
withdrawal time (minutes)
Withdrawal time, as defined, refers to the period between the commencement of withdrawing the colonoscope from the cecum and the complete removal of the colonoscope from the patient.
Measured: during the procedure
polyp detection rate
It will be assessed by recording the encountered polyps during colonoscopy.
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 Jan 2024
- Study start1 Oct 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety StateStudies 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 92 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
- Investigators
- selim demirci, Principal investigator, clinical physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187233
- Sponsor's protocol ID
- colonoscopybinaural
- Status last verified
- Dec 2023
- First submitted
- 17 Dec 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tani A, Tartarisco G, Vagheggini G, Vaccaro C, Campana S, Tomaiuolo F. Binaural beats reduce feeling of pain and discomfort during colonoscopy procedure in not-sedated patients: A randomized control trial. Complement Ther Clin Pract. 2022 Aug;48:101605. doi: 10.1016/j.ctcp.2022.101605. Epub 2022 May 21.
PubMed 35623152Isik 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 28325532Wang MC, Zhang LY, Zhang YL, Zhang YW, Xu XD, Zhang YC. Effect of music in endoscopy procedures: systematic review and meta-analysis of randomized controlled trials. Pain Med. 2014 Oct;15(10):1786-94. doi: 10.1111/pme.12514. Epub 2014 Aug 19.
PubMed 25139786
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Binaural Beats on Pain, Anxiety, and Procedure Tolerance in Patients Undergoing Colonoscopy Without Sedation
- ClinicalTrials.gov ID
- NCT06187233
- Acronym / sponsor ID
- colonoscopybinaural
- Conditions
- Anxiety State, Patient Satisfaction, Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 2 Jan 2024 (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.
The purpose of this study was to investigate the effect of binaural beats on anxiety, pain and tolerance during colonoscopy without sedation
Detailed description
It is a prospective randomized, controlled, single-blind procedural study included 92 Turkish patients aged 18-70 years old scheduled for colonoscopy regardless of sex or underlying disease. The patients were randomly divided into two groups: the binaural beat music group(n=46) and the control group(n=46). The binaural music group listened to music through headphones during colonoscopy, while the control group had headphones without music. Anxiety levels (VAS-Anxiety scale) were measured both before and after the procedure, and pain levels (VAS-pain) were measured following the procedure. Hemodynamic changes before and after endoscopy , procedure tolerance (using modified gloucester comfort scale), cecal insertion and withdrawal times, polyp detection rate, and patients' experiences related to colonoscopy were recorded. Likert scales were collected as well just after the colonoscopy procedure, indicating satisfaction and willingness to repeat the process.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| binaural music group | Experimental | Other: binaural musicThe music group listened to music containing binaural beats during the colonoscopy |
| control | No intervention | –The control group had headphones without sound during 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 colonoscopy 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 during the procedure. | Other | binaural music group |
Primary outcome
VAS-anxiety
Time frame: immediately before being taken into the procedure room and 5 minutes after the procedure
The VAS scale, developed by Price et al. (1983), has been employed in recent years to measure patients' subjective experiences of pain and anxiety.This scale utilizes a 10-cm horizontal or vertical line, with the two endpoints representing the minimum and maximum scores for pain and anxiety(0: no pain/no anxiety, 10: the most severe pain/extremely anxious). The colonoscopy nurse recorded patients' pain and anxiety scores by manually marking a 10-cm line. This indicator is a reliable measure for assessing pain and anxiety
VAS-pain
Time frame: 5 minutes after the procedure
The VAS scale, developed by Price et al. (1983), has been employed in recent years to measure patients' subjective experiences of pain and anxiety.This scale utilizes a 10-cm horizontal or vertical line, with the two endpoints representing the minimum and maximum scores for pain and anxiety(0: no pain/no anxiety, 10: the most severe pain/extremely anxious). The colonoscopy nurse recorded patients' pain and anxiety scores by manually marking a 10-cm line. This indicator is a reliable measure for assessing pain and anxiety
The Modified Gloucester Comfort Scale
Time frame: During the procedure
The endoscopy nurse recorded and analyzed data related to patient comfort, encompassing compliance and tolerance during the procedure, using the Modified Gloucester Comfort Scale.Discomfort, characterized by severe belching, retching, coughing, and non-compliance, was assessed on a scale where the absence of discomfort received a score of 1 point, while extreme discomfort during the procedure was assigned 5 points.
6 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
cecal insertion time(minutes)
Time frame: during the procedure
withdrawal time (minutes)
Time frame: during the procedure
polyp detection rate
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 Jan 2024.
- Results publication: PubMed 35623152Tani A, Tartarisco G, Vagheggini G, Vaccaro C, Campana S, Tomaiuolo F. Binaural beats reduce feeling of pain and discomfort during colonoscopy procedure in not-sedated patients: A randomized control trial. Complement Ther Clin Pract. 2022 Aug;48:101605. doi: 10.1016/j.ctcp.2022.101605. Epub 2022 May 21.
- 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 25139786Wang MC, Zhang LY, Zhang YL, Zhang YW, Xu XD, Zhang YC. Effect of music in endoscopy procedures: systematic review and meta-analysis of randomized controlled trials. Pain Med. 2014 Oct;15(10):1786-94. doi: 10.1111/pme.12514. Epub 2014 Aug 19.
- Individual participant dataSharing planned: No
Related trials for Anxiety State
Not yet recruiting
The Effect of Skin-to-Skin Contact on Pain and Anxiety During Episiotomy Repair
Episiotomy, Pain
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Not yet recruiting
Virtual Reality for Anxiety and Birth Satisfaction During Elective Cesarean Section
Anxiety, Cesarean Section
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
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.
selim demirci principal investigator
clinical physician
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 Anxiety State and Patient Satisfaction, 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 Jan 2024. 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?
VAS-anxiety (time frame: immediately before being taken into the procedure room and 5 minutes after the procedure). The study lists 3 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 NCT06187233, which also lists 3 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 Jan 2024.