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Clinical Trials/NCT06114524
NCT06114524
Completed
Not Applicable

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

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital1 site in 1 country96 target enrollmentSeptember 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patient Satisfaction
Sponsor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Enrollment
96
Locations
1
Primary Endpoint
State-Trait Anxiety Inventory (STAI)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2023
End Date
October 25, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

selim demirci

medical doctor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

State-Trait Anxiety Inventory (STAI)

Time Frame: 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 Outcomes

  • Heart rate(Within 20 minutes pre-procedure and 5 minutes after the procedure)
  • Patient satisfaction(5 minutes after the procedure)
  • Blood pressure(Within 20 minutes pre-procedure and 5 minutes after the procedure)
  • patient tolerance(During the procedure)

Study Sites (1)

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