NCT06114524

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

1 month

First QC Date

October 25, 2023

Last Update Submit

October 27, 2023

Conditions

Patient SatisfactionAnxiety StateTolerance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Patient satisfaction

    5 minutes after the procedure

  • Heart rate

    Within 20 minutes pre-procedure and 5 minutes after the procedure

  • Blood pressure

    Within 20 minutes pre-procedure and 5 minutes after the procedure

  • patient tolerance

    During the procedure

Study Arms (2)

binaural music group

EXPERIMENTAL

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

Other: binaural music

control

NO INTERVENTION

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

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.

binaural music group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Between 18-70 years old who had scheduled upper gastrointestinal endoscopy appointments

You may not qualify if:

  • Anxiety and panic disorders
  • Urgent endoscopic intervention
  • Advanced dementia
  • Hearing problems
  • Anatomical or inflammatory disorders in the external ear canals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abdurrahman Yurtaslan Oncology and Training Research Hospital

Ankara, 06200, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 35713444BACKGROUND

  • 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.

    PMID: 28325532RESULT

  • 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.

    PMID: 16115248RESULT

  • 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.

    PMID: 39088370DERIVED

MeSH Terms

Conditions

Patient SatisfactionAnxiety Disorders

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

October 25, 2023

First Posted

November 2, 2023

Study Start

September 15, 2023

Primary Completion

October 25, 2023

Study Completion

October 25, 2023

Last Updated

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)