Pain
Conditions
Keywords
Binaural Beats, Colonscopy
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.
Interventions
DEVICEBinaural Beats
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
Sponsors
Azienda USL Toscana Nord Ovest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain perception evaluated with VAS | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparison between the two groups of the level of satisfaction: Likert scale | 5 minutes after completing the procedure (complete withdrawal of the colonoscope) | 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; |
| 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); | Systolic and diastolic blood pressure evaluation measured in millimeters of Hg |
| 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); | Heart rate evaluation measured in beats/min. |
| comparison on the number of subjects who could not complete the exam | at the end of the planned study in a year | comparison on the number of subjects between the two groups who could not complete the exam due to intolerance |
| comparison on the use of drugs during the procedure | at the end of the planned study in a year | comparison between the two groups on the use of atropine during the procedure to reduce vagal effects |
Countries
Italy
Outcome results
None listed