Effect of Music Over the Tolerance to Colonoscopy. (EMOC)

Pontificia Universidad Catolica de Chile

Status and phase: Unknown; Phase 4

Conditions: Anxiety; Pain

Treatments: Other: No music; Other: Music

Study type: Interventional

Funder types: Other

Identifiers

NCT01285284

10-237

Details and patient eligibility

About

This study will evaluate the efficacy of music (a very well selected list of songs)on improving the tolerance to the colonoscopy. The patients will be randomly assigned to receive music or not. The authors hypothesis is that music is able to improve the tolerance to colonoscopy evaluated as a reduction on the level of anxiety, on the intensity of pain experimented during the procedure and a reduction of the administered dose of midazolam during the colonoscopy.

Full description

To select the music that will be administered on this trial we will performed as the first part of the study, a two fase pilot study. In the first part, five song belonging to different musical styles (Rock, Bosa Nova, Classical Music, Popular chilean music and New age) will be heard by 40 persons and the main emotion produced by every song will be registered (chosen among a previously defined list of emotions) and then rated using a visual analog scale. Thus, we will be able to select the musical style that with more frequency produce "tranquility and/or peace". Once this musical style will be selected we generate a set of songs belonging to this style. This set of songs will be validated using again a similar methodology in the second part of the pilot study to be sure that is able to produce the same emotion that the song previously evaluated. The validated set of songs will be the music that will be administered to the patients participating on a multicentric randomized controlled trial where the effect of the selected music over the tolerance to colonoscopy will be evaluated measuring the level of anxiety, the administered dose of midazolam and the intensity of pain experimented during the procedure among another variables on the experimental and the control groups, including 150 patients on each arm.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (over 18 years)
• Diagnostic colonoscopy
• Signed informed consent

Exclusion criteria

• Hypoacusia
• Significant cognitive impairment
• Hypotension
• Signs of digestive haemorrhage (other than a small amount of rectorrhagia)
• More than moderate intensity of pain before the colonoscopy.
• Previous colorectal surgery
• allergy to midazolam or pethidine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Music

Experimental group

Description:

A previously defined list of songs will be administered by headphones to these patients during the colonoscopy.

Treatment:

Other: Music

Control

Sham Comparator group

Description:

These patients will receive an MP3 device (and headphones) which will be functioning but without volume.

Treatment:

Other: No music