An interventional study of binaural music in Patient Satisfaction, Anxiety State and Tolerance, sponsored by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital · Not applicable, Interventional, and Prevention
To investigate the anxiolytic effects of binaural beat-embedded audio in patients undergoing sedation-free upper gastrointestinal endoscopy
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.
4,874 studies on the registry are indexed under Anxiety Disorders; 1,394 are open to participants now.
This study's enrollment of 96 is above the median of 80 across 4,180 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital is the lead sponsor of 73 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Binaural music therapy was applied for 15 min before the procedure.
Other: binaural music
The control group was kept in a quiet room for 15 minutes before the procedure and then taken for the procedure.
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.
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
Time frame: Within 20 minutes pre-procedure and 5 minutes after the procedure
Patient satisfaction
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.
Time frame: 5 minutes after the procedure
Heart rate
The comparison of heart rate in the music and control groups
Time frame: Within 20 minutes pre-procedure and 5 minutes after the procedure
Blood pressure
The comparison of systolic and diastolic blood pressure in the music and control groups
Time frame: Within 20 minutes pre-procedure and 5 minutes after the procedure
patient tolerance
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).
Time frame: During the procedure
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital