Evaluation of Pain and Patient Satisfaction Using Binaural Beats in Patients Submitted to Colonoscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Pain perception evaluated with VAS
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Binaural Beats
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
Intervention: Binaural Beats (Device)
No sounds
Group B : use of stereo headphones with a white background noise
Outcomes
Primary Outcomes
Pain perception evaluated with VAS
Time Frame: 5 minutes after completing the procedure (complete withdrawal of the colonoscope)
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.
Secondary Outcomes
- comparison on the use of drugs during the procedure(at the end of the planned study in a year)
- Blood pressure assessment(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(at the end of the planned study in a year)
- Comparison between the two groups of the level of satisfaction: Likert scale(5 minutes after completing the procedure (complete withdrawal of the colonoscope))
- Heart rate assessment(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);)
Investigators
Alessandro Tani
Principal Investigator
Azienda USL Toscana Nord Ovest