Use of Binaural Beats for Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Investigators verify the effectiveness of binaural beats to reduce pain during colonoscopy .

Detailed Description
-----------------
Colonoscopy is a disturbing and painful procedure, so whenever possible it is performed in sedation. Although the use of sedative drugs is effective in relieving anxiety and pain such drugs can cause significant side-effects. This study examines the effect of Binaural Beats stimulation on pain perception during colonscopy. Binaural Beats is a simple technique, described for the first time since by Gerald Oster , that include the presentation of two acoustic stimuli with similar frequencies through the two channels of stereo headphones. The interference of their waves which occurs at the level of the central nervous system, produces a composite signal with a frequency resulting from the difference of the two original frequencies. For example if you give an acoustic stimulus of 100 Hz to an ear and simultaneously administering another acoustic stimulation of 104 Hz to the opposite ,ear the person who listens to these stimuli will perceive a Binaural Beat of 4 Hz caused by the difference between the two frequencies. These Binaural Beats are of interest because they have been thought to cause hemispheric synchronization and influence the EEG frequency like light stimulation . Binaural Beats have already been used in humans undergoing outpatient surgery in urogynecological and have been shown to help increase patient comfort by reducing the state of anxiety and pain without interfering negatively with postoperative functional recovery . In this study the investigators evaluate the use of Binaural Beat in outpatients to undergo colonoscopy to reduce pain . A total of 100 patients divided into two groups, 50 treatment and 50 control will be considered. Both patient groups will be invited to wear headphones regardless of whether they have been randomized to Binaural Beats with white noise or white noise only to ensure blindness of participation The headphones will be worn ten minutes before and throughout the procedure. Pain will be measured by VAS scale and satisfaction by Likert scale after the procedure in both groups. Blood pressure and heart rate will be monitored before, during, and after the procedure.

Official Title
-----------------
Evaluation of Pain and Patient Satisfaction Using Binaural Beats in Patients Submitted to Colonoscopy

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Device: Binaural Beats


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for outpatient colonoscopy Valid consent expression to the study participation Good collaboration in activities provided by the study Exclusion Criteria: Insufficient degree of collaboration Abnormal hearing Denial of informed consent to participate in the study Previous colon resection surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Binaural Beats<br>Group A : use of stereo headphones that generate sound with Binaural Beats at acoustic frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a binaural beat of 4 Hz with a white background noise | Device: Binaural Beats<br>* Device: Sound with Binaural Beats at acoustic frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a binaural beat of 4 Hz with a white background noise<br>|
| No Intervention: No sounds<br>Group B : use of stereo headphones with a white background noise | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perception evaluated with VAS | Comparison between the two groups of pain perceived during the procedure by VAS scale. The Visual Analogue Scale (VAS) is a validated scale for measuring pain on 11 points, from 0 to 10, in which the patient indicates the maximum perceived pain. | 5 minutes after completing the procedure (complete withdrawal of the colonoscope) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between the two groups of the level of satisfaction: Likert scale | Comparison between the two groups of the level of satisfaction of the entire procedure measured with a Likert scale . Likert scale is a scale which is used to allow the individual to express how much they agree or disagree with a particular statement patient satisfaction rated as: not at all, very low, moderate satisfaction, complete satisfaction; (b) willingness to repeat the procedure in the future: not at all, very low, barely yes, yes; | 5 minutes after completing the procedure (complete withdrawal of the colonoscope) | 
| Blood pressure assessment | Systolic and diastolic blood pressure evaluation measured in millimeters of Hg | 3 minutes before inserting the colonoscope (this was baseline), 5 minutes after colonoscope insertion and 3 minutes after completing the procedure (complete withdrawal of the colonoscope); | 
| Heart rate assessment | Heart rate evaluation measured in beats/min. | 3 minutes before inserting the colonoscope (this was baseline), 5 minutes after colonoscope insertion and 3 minutes after completing the procedure (complete withdrawal of the colonoscope); | 
| comparison on the number of subjects who could not complete the exam | comparison on the number of subjects between the two groups who could not complete the exam due to intolerance | at the end of the planned study in a year | 
| comparison on the use of drugs during the procedure | comparison between the two groups on the use of atropine during the procedure to reduce vagal effects | at the end of the planned study in a year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Binaural Beats, Colonscopy