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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Pontificia Universidad Catolica de Chile.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Clínica UC San Carlos de Apoquindo.
Hospital Provicial Dr. Rafael Avaria Valenzuela
Information provided by:
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT01285284
First received: January 26, 2011
Last updated: August 8, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Pain
Anxiety
Other: Music
Other: No music
Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 300
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)
Arms Assigned Interventions
Experimental: Music
A previously defined list of songs will be administered by headphones to these patients during the colonoscopy.
Other: Music
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285284

Contacts
Contact: Carlos E Benítez, M.D. 56-02-3543820 ext 3880 cbenitez@med.puc.cl

Locations
Chile
Hospital Provicial Dr. Rafael Avaria Valenzuela Recruiting
Curanilahue, Octava Región, Chile, 444444
Contact: Andrés Jorquera, M.D.    56-41-2725480    aajorque@gmail.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    arnoldoriquelme@gmail.com   
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    lucciomendez@gmail.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    nonoymorales@gmail.com   
Principal Investigator: Eugenia Morales, M.D.         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Clínica UC San Carlos de Apoquindo.
Hospital Provicial Dr. Rafael Avaria Valenzuela
Investigators
Principal Investigator: Carlos E Benítez, M.D. Gastroenterology Department. Pontificia Universidad Católica de Chile
  More Information

Publications:

Responsible Party: Carlos Benítez Gajardo, Gastroenterology Department, Hospital Clínico de la Pontificia Universidad Católica de Chile
ClinicalTrials.gov Identifier: NCT01285284     History of Changes
Other Study ID Numbers: 10-237
Study First Received: January 26, 2011
Last Updated: August 8, 2011
Health Authority: Chile: Comité de Ética del Hospital Clínico de la Pontificia Universidad Católica de Chile

Keywords provided by Pontificia Universidad Catolica de Chile:
Colonoscopy
Music
Tolerance
Pain
Anxiety
Dose of sedative drugs administered during the procedure

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014