Clinical trial NCT06187233: The Effects of Binaural Beats on Pain, Anxiety, and Procedure Tolerance in Patients Undergoing Colonoscopy Without Sedation
Official title: The Effects of Binaural Beats on Pain, Anxiety, and Procedure Tolerance in Patients Undergoing Colonoscopy Without Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety State
Patient Satisfaction
Tolerance
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

- Between 18-70 years old who had scheduled colonoscopy appointments

Exclusion Criteria:

* Anxiety and panic disorders
* Urgent endoscopic intervention
* Advanced dementia
* Hearing problems
* Anatomical or inflammatory disorders in the external ear canals

Primary outcomes:
measure: VAS-anxiety
timeFrame: immediately before being taken into the procedure room and 5 minutes after the procedure
measure: VAS-pain
timeFrame: 5 minutes after the procedure
measure: The Modified Gloucester Comfort Scale
timeFrame: During the procedure
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 5 minutes after the procedure
measure: Heart rate
timeFrame: Within 20 minutes pre-procedure and 5 minutes after the procedure
measure: Blood pressure
timeFrame: Within 20 minutes pre-procedure and 5 minutes after the procedure
measure: cecal insertion time(minutes)
timeFrame: during the procedure
measure: withdrawal time (minutes)
timeFrame: during the procedure
measure: polyp detection rate
timeFrame: during the procedure
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Abdurrahman Yurtaslan Oncology and Training Research Hospital
Study officials:
affiliation: clinical physician
name: selim demirci
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Isik 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.
citation: Wang 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.