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

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

Detailed Description
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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.

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

Conditions
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Patient Satisfaction, Anxiety State, Tolerance

Intervention / Treatment
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* Other: binaural music


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: binaural music group<br>Binaural music therapy was applied for 15 min before the procedure. | Other: binaural music<br>* 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.<br>|
| No Intervention: control<br>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?
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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 |