Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation

To investigate the anxiolytic effects of binaural beat-embedded audio in patients undergoing sedation-free upper gastrointestinal endoscopy

Study Overview

• Status: Completed
• Conditions: Anxiety State; Patient Satisfaction; Tolerance
• Intervention / Treatment: Other: binaural music

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06200
    • Abdurrahman Yurtaslan Oncology and Training Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: binaural music group; Binaural music therapy was applied for 15 min before the procedure.	Other: binaural music; 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.
No Intervention: control; The control group was kept in a quiet room for 15 minutes before the procedure and then taken for the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within 20 minutes pre-procedure and 5 minutes after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 minutes after the procedure
Heart rate	The comparison of heart rate in the music and control groups	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	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).	During the procedure

Collaborators and Investigators

• Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): October 25, 2023
• Study Completion (Actual): October 25, 2023

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Binaural

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No