Clinical trial NCT06114524: Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation
Official title: Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Anxiety State
Tolerance
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 96
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: 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.

Eligibility criteria: Inclusion Criteria:

- Between 18-70 years old who had scheduled upper gastrointestinal endoscopy 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: State-Trait Anxiety Inventory (STAI)
timeFrame: Within 20 minutes pre-procedure and 5 minutes after 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: patient tolerance
timeFrame: During the procedure
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Abdurrahman Yurtaslan Oncology and Training Research Hospital
Study officials:
References:
citation: 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.
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: Padmanabhan 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.