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

NCT ID: NCT06114524

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2023-10-25

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.

Conditions

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Patient Satisfaction Anxiety State Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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binaural music group

Binaural music therapy was applied for 15 min before the procedure.

Group Type EXPERIMENTAL

binaural music

Intervention Type OTHER

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.

control

The control group was kept in a quiet room for 15 minutes before the procedure and then taken for the procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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selim demirci

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Abdurrahman Yurtaslan Oncology and Training Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 35713444 (View on PubMed)

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.

Reference Type RESULT
PMID: 28325532 (View on PubMed)

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.

Reference Type RESULT
PMID: 16115248 (View on PubMed)

Demirci S, Sezer S. Effect of Binaural Beats on Anxiety and Tolerance in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation: A Randomized Controlled Trial. J Integr Complement Med. 2024 Dec;30(12):1209-1216. doi: 10.1089/jicm.2023.0804. Epub 2024 Aug 1.

Reference Type DERIVED
PMID: 39088370 (View on PubMed)

Other Identifiers

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Binaural

Identifier Type: -

Identifier Source: org_study_id

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