Effect of Music Over the Tolerance to Colonoscopy. (EMOC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|