Effect of Music Over the Tolerance to Colonoscopy. (EMOC)
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
|Official Title:||The Effect of Music Over the Tolerance to Colonoscopy ¿Does it Reduce the Discomfort, the Anxiety and the Need of Sedation? Multicentric Randomized Controlled Trial.|
- The administered dose of midazolam [ Time Frame: After colonoscopy is finished. ] [ Designated as safety issue: No ]The accumulated dose of midazolam administered during the procedure will be registered and compared between both arms.
- Level of anxiety [ Time Frame: rigth before colonoscopy and after it at the moment of discharge ] [ Designated as safety issue: No ]We will use a self-adminsitered questonary (STAI)
- Evolution of vital signs [ Time Frame: Rigth before and during the colonoscopy ] [ Designated as safety issue: No ]Heart rate and blood pressure will be measured right before the colonoscopy, five and ten minutes after its start.
- Colonoscopy time [ Time Frame: During the colonoscopy ] [ Designated as safety issue: No ]The time elapsed since the beginning of the colonoscopy until its end.
- Patient's global evaluation of the procedure [ Time Frame: after the colonoscopy at the moment of discharge. ] [ Designated as safety issue: No ]After the procedure the patient will evaluate the procedure as : a)Very Bad, b)Bad, c)Good, d)Very Good.
- Time since the beginning of the procedure until the discharge [ Time Frame: since the beginning of the procedure until the discharge. ] [ Designated as safety issue: No ]The time elapsed since the beginning of the procedure until the discharge.
- How difficult the colonoscopy was? [ Time Frame: After the procedure. ] [ Designated as safety issue: No ]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.
- Adverse effects [ Time Frame: Since the begining of the procedure until the discharge. ] [ Designated as safety issue: Yes ]Every unexpected and adverse effect will be registered.
- The level of pain [ Time Frame: After colonoscopy at the moment of discharge ] [ Designated as safety issue: No ]Using a Visual Analog Scale, the intensity of pain experimented during the colonoscopy will be evaluated after the procedure on both arms.
- Willing of repeating the procedure. [ Time Frame: After colonoscopy at the moment of discharge ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
A previously defined list of songs will be administered by headphones to these patients during the colonoscopy.
A previously defined list of songs will be administered by headphones to these patients.
Sham Comparator: Control
These patients will receive an MP3 device (and headphones) which will be functioning but without volume.
Other: No music
No music will be administered by the headphones connected to the MP3 device.
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.
|Contact: Carlos E Benítez, M.D.||56-02-3543820 ext firstname.lastname@example.org|
|Hospital Provicial Dr. Rafael Avaria Valenzuela||Recruiting|
|Curanilahue, Octava Región, Chile, 444444|
|Contact: Andrés Jorquera, M.D. 56-41-2725480 email@example.com|
|Principal Investigator: Andrés Jorquera, M.D.|
|Clínica UC San Carlos de Apoquindo||Recruiting|
|Santiago, Región Metropolitana, Chile, 8320000|
|Contact: Arnoldo Riquelme, M.D. 56-45-7548700 firstname.lastname@example.org|
|Principal Investigator: Arnoldo Riquelme, M.D.|
|Hospital Clínico. Pontificia Universidad Católica de Chile||Recruiting|
|Santiago, RM, Chile, 8330024|
|Contact: Luis Méndez, M.D. 56-02-3543820 ext 3880 email@example.com|
|Principal Investigator: Carlos E Benítez, M.D.|
|Centro Médico UC San Joaquín||Recruiting|
|Santiago, RM, Chile, 8320000|
|Contact: Eugenia Morales, M.D. 354 8500 ext 3333 firstname.lastname@example.org|
|Principal Investigator: Eugenia Morales, M.D.|
|Principal Investigator:||Carlos E Benítez, M.D.||Gastroenterology Department. Pontificia Universidad Católica de Chile|