The Effects of Binaural Beats on Pain, Anxiety, and Procedure Tolerance in Patients Undergoing Colonoscopy Without Sedation

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

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2023-11-30

Brief Summary

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The purpose of this study was to investigate the effect of binaural beats on anxiety, pain and tolerance during colonoscopy without sedation

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Detailed Description

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It is a prospective randomized, controlled, single-blind procedural study included 92 Turkish patients aged 18-70 years old scheduled for colonoscopy regardless of sex or underlying disease. The patients were randomly divided into two groups: the binaural beat music group(n=46) and the control group(n=46). The binaural music group listened to music through headphones during colonoscopy, while the control group had headphones without music. Anxiety levels (VAS-Anxiety scale) were measured both before and after the procedure, and pain levels (VAS-pain) were measured following the procedure. Hemodynamic changes before and after endoscopy , procedure tolerance (using modified gloucester comfort scale), cecal insertion and withdrawal times, polyp detection rate, and patients' experiences related to colonoscopy were recorded. Likert scales were collected as well just after the colonoscopy procedure, indicating satisfaction and willingness to repeat the process.

Conditions

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Anxiety State Patient Satisfaction Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

All elective colonoscopies were performed by an experienced endoscopists who were unaware of the group assignments.

Study Groups

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binaural music group

The music group listened to music containing binaural beats during the colonoscopy

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 during the procedure.

control

The control group had headphones without sound during 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 during the procedure.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- Between 18-70 years old who had scheduled colonoscopy 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