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

Sponsor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06114524
Collaborator
(none)
96
Enrollment
1
Location
2
Arms
1.3
Actual Duration (Months)
73.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: binaural music
 N/A

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation
Actual Study Start Date :
Sep 15, 2023
Actual Primary Completion Date :
Oct 25, 2023
Actual Study Completion Date :
Oct 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: binaural music group

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

Other: 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.
No Intervention: control

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

Outcome Measures

Primary Outcome Measures

  1. State-Trait Anxiety Inventory (STAI) [Within 20 minutes pre-procedure and 5 minutes after the procedure]

    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

Secondary Outcome Measures

  1. Patient satisfaction [5 minutes after the procedure]

    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.

  2. Heart rate [Within 20 minutes pre-procedure and 5 minutes after the procedure]

    The comparison of heart rate in the music and control groups

  3. Blood pressure [Within 20 minutes pre-procedure and 5 minutes after the procedure]

    The comparison of systolic and diastolic blood pressure in the music and control groups

  4. patient tolerance [During the procedure]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Abdurrahman Yurtaslan Oncology and Training Research Hospital Ankara Turkey 06200

Sponsors and Collaborators

  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
selim demirci, medical doctor, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT06114524
Other Study ID Numbers:
  • Binaural
First Posted:
Nov 2, 2023
Last Update Posted:
Nov 2, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anxiety Disorders

Study Results

No Results Posted as of Nov 2, 2023