A Phase 4 interventional study of Music and No music in Pain and Anxiety, sponsored by Pontificia Universidad Catolica de Chile. Status unknown at 4 sites in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-09.
Sponsored by Pontificia Universidad Catolica de Chile · Phase 4, Interventional, and Treatment
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.
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.
4,864 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.
This study's planned enrollment of 300 is above the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A previously defined list of songs will be administered by headphones to these patients during the colonoscopy.
Other: Music
These patients will receive an MP3 device (and headphones) which will be functioning but without volume.
Other: No music
A previously defined list of songs will be administered by headphones to these patients.
No music will be administered by the headphones connected to the MP3 device.
The administered dose of midazolam
The accumulated dose of midazolam administered during the procedure will be registered and compared between both arms.
Time frame: After colonoscopy is finished.
Level of anxiety
We will use a self-adminsitered questonary (STAI)
Time frame: rigth before colonoscopy and after it at the moment of discharge
Evolution of vital signs
Heart rate and blood pressure will be measured right before the colonoscopy, five and ten minutes after its start.
Time frame: Rigth before and during the colonoscopy
Colonoscopy time
The time elapsed since the beginning of the colonoscopy until its end.
Time frame: During the colonoscopy
Patient's global evaluation of the procedure
After the procedure the patient will evaluate the procedure as : a)Very Bad, b)Bad, c)Good, d)Very Good.
Time frame: after the colonoscopy at the moment of discharge.
Time since the beginning of the procedure until the discharge
The time elapsed since the beginning of the procedure until the discharge.
Time frame: since the beginning of the procedure until the discharge.
How difficult the colonoscopy was?
At the end of the colonoscopy the endocopist will be asking about how difficult the procedure was, choosing one of the following alternatives: a)Less than usual, b) as usual, c) more than usual, d) much more than usual.
Time frame: After the procedure.
Adverse effects
Every unexpected and adverse effect will be registered.
Time frame: Since the begining of the procedure until the discharge.
The level of pain
Using a Visual Analog Scale, the intensity of pain experimented during the colonoscopy will be evaluated after the procedure on both arms.
Time frame: After colonoscopy at the moment of discharge
Willing of repeating the procedure.
After the procedure the patient will be asked about the willingness of repeating the procedure if necesary, choosing one of the following ones: a) Absolutely no, b) Possibly no, c) Possibly yes, d) Absolutely yes.
Time frame: After colonoscopy at the moment of discharge
This study is status unknown, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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Pontificia Universidad Catolica de Chile