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

August 8, 2011 updated by: Pontificia Universidad Catolica de Chile

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.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Chile
    • Octava Región
      • Curanilahue, Octava Región, Chile, 444444
        • Recruiting
        • Hospital Provicial Dr. Rafael Avaria Valenzuela
        • Contact:
        • Principal Investigator:
          • Andrés Jorquera, M.D.
    • RM
      • Santiago, RM, Chile, 8320000
        • Recruiting
        • Centro Médico UC San Joaquín
        • Contact:
        • Principal Investigator:
          • Eugenia Morales, M.D.
      • Santiago, RM, Chile, 8330024
        • Recruiting
        • Hospital Clínico. Pontificia Universidad Católica de Chile
        • Contact:
        • Principal Investigator:
          • Carlos E Benítez, M.D.
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 8320000
        • Recruiting
        • Clinica UC San Carlos de Apoquindo
        • Contact:
        • Principal Investigator:
          • Arnoldo Riquelme, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After colonoscopy is finished.
Level of anxiety
Time Frame: rigth before colonoscopy and after it at the moment of discharge
We will use a self-adminsitered questonary (STAI)
rigth before colonoscopy and after it at the moment of discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Rigth before and during the colonoscopy
Colonoscopy time
Time Frame: During the colonoscopy
The time elapsed since the beginning of the colonoscopy until its end.
During the colonoscopy
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.
after the colonoscopy at the moment of discharge.
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.
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.
After the procedure.
Adverse effects
Time Frame: Since the begining of the procedure until the discharge.
Every unexpected and adverse effect will be registered.
Since the begining of the procedure until the discharge.
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.
After colonoscopy at the moment of discharge
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.
After colonoscopy at the moment of discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

October 1, 2011

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

January 26, 2011

First Posted (Estimate)

January 27, 2011

Study Record Updates

Last Update Posted (Estimate)

August 9, 2011

Last Update Submitted That Met QC Criteria

August 8, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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