Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation
- Conditions
- Anxiety StateTolerancePatient Satisfaction
- Interventions
- Other: binaural music
- Registration Number
- NCT06114524
- Lead Sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- Between 18-70 years old who had scheduled upper gastrointestinal endoscopy appointments
- Anxiety and panic disorders
- Urgent endoscopic intervention
- Advanced dementia
- Hearing problems
- Anatomical or inflammatory disorders in the external ear canals
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description binaural music group binaural music Binaural music therapy was applied for 15 min before the procedure.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Heart rate Within 20 minutes pre-procedure and 5 minutes after the procedure The comparison of heart rate in the music and control groups
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.
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
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).
Trial Locations
- Locations (1)
Abdurrahman Yurtaslan Oncology and Training Research Hospital
🇹🇷Ankara, Turkey