Anxiety State, Patient Satisfaction, Tolerance
Conditions
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.
Interventions
OTHERbinaural 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.
Sponsors
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Heart rate | Within 20 minutes pre-procedure and 5 minutes after the procedure | The comparison of heart rate in the music and control groups |
| 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). |
Countries
Turkey (Türkiye)
Outcome results
None listed