Effect of Music Over the Tolerance to Colonoscopy. (EMOC)
|ClinicalTrials.gov Identifier: NCT01285284|
Recruitment Status : Unknown
Verified March 2011 by Pontificia Universidad Catolica de Chile.
Recruitment status was: Recruiting
First Posted : January 27, 2011
Last Update Posted : August 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pain Anxiety||Other: Music Other: No music||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|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.|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||September 2011|
|Estimated Study Completion Date :||October 2011|
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.
- The administered dose of midazolam [ Time Frame: After colonoscopy is finished. ]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 ]We will use a self-adminsitered questonary (STAI)
- Evolution of vital signs [ Time Frame: Rigth before and during the colonoscopy ]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 ]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. ]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. ]The time elapsed since the beginning of the procedure until the discharge.
- How difficult the colonoscopy was? [ Time Frame: After the procedure. ]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. ]Every unexpected and adverse effect will be registered.
- The level of pain [ Time Frame: After colonoscopy at the moment of discharge ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285284
|Contact: Carlos E Benítez, M.D.||56-02-3543820 ext email@example.com|
|Hospital Provicial Dr. Rafael Avaria Valenzuela||Recruiting|
|Curanilahue, Octava Región, Chile, 444444|
|Contact: Andrés Jorquera, M.D. 56-41-2725480 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Arnoldo Riquelme, 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.|
|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.|
|Principal Investigator:||Carlos E Benítez, M.D.||Gastroenterology Department. Pontificia Universidad Católica de Chile|