Skip to main content
OpenTrials
Completed

NCT Number: NCT06114524

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patient Satisfaction Anxiety Disorders Anxiety State Behavior Health Behavior Mental Disorders Tolerance Treatment Adherence and Compliance

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abdurrahman Yurtaslan Oncology and Training Research Hospital

Ankara, 06200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

binaural music

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.

Primary outcomes

  1. 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

  1. Patient satisfaction

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2023
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.