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

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital96 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Patient Satisfaction Anxiety State Tolerance

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Abdurrahman Yurtaslan Oncology and Training Research Hospital

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

Time frame: Within 20 minutes pre-procedure and 5 minutes after the procedure

Secondary Outcomes

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.

Time frame: 5 minutes after the procedure

Heart rate

The comparison of heart rate in the music and control groups

Time frame: 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

Time frame: 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).

Data from ClinicalTrials.gov

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