Anxiety State, Patient Satisfaction, Tolerance
Conditions
Brief summary
The purpose of this study was to investigate the effect of binaural beats on anxiety, pain and tolerance during colonoscopy without sedation
Detailed description
It is a prospective randomized, controlled, single-blind procedural study included 92 Turkish patients aged 18-70 years old scheduled for colonoscopy regardless of sex or underlying disease. The patients were randomly divided into two groups: the binaural beat music group(n=46) and the control group(n=46). The binaural music group listened to music through headphones during colonoscopy, while the control group had headphones without music. Anxiety levels (VAS-Anxiety scale) were measured both before and after the procedure, and pain levels (VAS-pain) were measured following the procedure. Hemodynamic changes before and after endoscopy , procedure tolerance (using modified gloucester comfort scale), cecal insertion and withdrawal times, polyp detection rate, and patients' experiences related to colonoscopy were recorded. Likert scales were collected as well just after the colonoscopy procedure, indicating satisfaction and willingness to repeat the process.
Interventions
OTHERbinaural music
In the binaural music group, an MP3 player and in-ear stereo headphones were provided. Music therapy was applied during the procedure.
Sponsors
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Masking description
All elective colonoscopies were performed by an experienced endoscopists who were unaware of the group assignments.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
\- Between 18-70 years old who had scheduled colonoscopy 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 |
|---|---|---|
| VAS-anxiety | immediately before being taken into the procedure room and 5 minutes after the procedure | The VAS scale, developed by Price et al. (1983), has been employed in recent years to measure patients' subjective experiences of pain and anxiety.This scale utilizes a 10-cm horizontal or vertical line, with the two endpoints representing the minimum and maximum scores for pain and anxiety(0: no pain/no anxiety, 10: the most severe pain/extremely anxious). The colonoscopy nurse recorded patients' pain and anxiety scores by manually marking a 10-cm line. This indicator is a reliable measure for assessing pain and anxiety |
| VAS-pain | 5 minutes after the procedure | The VAS scale, developed by Price et al. (1983), has been employed in recent years to measure patients' subjective experiences of pain and anxiety.This scale utilizes a 10-cm horizontal or vertical line, with the two endpoints representing the minimum and maximum scores for pain and anxiety(0: no pain/no anxiety, 10: the most severe pain/extremely anxious). The colonoscopy nurse recorded patients' pain and anxiety scores by manually marking a 10-cm line. This indicator is a reliable measure for assessing pain and anxiety |
| The Modified Gloucester Comfort Scale | During the procedure | The endoscopy nurse recorded and analyzed data related to patient comfort, encompassing compliance and tolerance during the procedure, using the Modified Gloucester Comfort Scale.Discomfort, characterized by severe belching, retching, coughing, and non-compliance, was assessed on a scale where the absence of discomfort received a score of 1 point, while extreme discomfort during the procedure was assigned 5 points. |
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 |
| cecal insertion time(minutes) | during the procedure | Insertion time, as defined, refers to the duration between the initiation of the colonoscopy procedure and the moment when the endoscope reaches the cecum, with identification of the appendiceal orifice. |
| withdrawal time (minutes) | during the procedure | Withdrawal time, as defined, refers to the period between the commencement of withdrawing the colonoscope from the cecum and the complete removal of the colonoscope from the patient. |
| polyp detection rate | during the procedure | It will be assessed by recording the encountered polyps during colonoscopy. |
Countries
Turkey (Türkiye)
Outcome results
None listed