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PainPhase 4EMOCNCT01285284

Effect of Music Over the Tolerance to Colonoscopy.

A Phase 4 study testing Music and No music in people with Pain and Anxiety, run by Pontificia Universidad Catolica de Chile at 4 sites in Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Anxiety
What is being tested?
Music and No music
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
4 sitesChile
Study dates
Mar 2011to Oct 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (over 18 years)
  • Diagnostic colonoscopy
  • Signed informed consent

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Carlos E Benítez, M.D. contact

56-02-3543820 ext. 3880

cbenitez@med.puc.cl

Chile4 sites, 4 recruiting

  • Hospital Provicial Dr. Rafael Avaria Valenzuela

    Curanilahue, Biobio, 444444

    Andrés Jorquera, M.D., 56-41-2725480, aajorque@gmail.com

    Andrés Jorquera, M.D.

    Recruiting

  • Centro Médico UC San Joaquín

    Santiago, RM, 8320000

    Eugenia Morales, M.D., 354 8500 ext. 3333, nonoymorales@gmail.com

    Eugenia Morales, M.D.

    Recruiting

  • Hospital Clínico. Pontificia Universidad Católica de Chile

    Santiago, RM, 8330024

    Luis Méndez, M.D., 56-02-3543820 ext. 3880, lucciomendez@gmail.com

    Carlos E Benítez, M.D.

    Recruiting

  • Clínica UC San Carlos de Apoquindo

    Santiago, Santiago Metropolitan, 8320000

    Arnoldo Riquelme, M.D., 56-45-7548700, arnoldoriquelme@gmail.com

    Arnoldo Riquelme, M.D.

    Recruiting

Other trials in Chile

About this study

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.

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.

Read the 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.

Conditions
Pain, Anxiety
Being tested
Music, No music
Keywords
Colonoscopy, Music, Tolerance, Pain, Anxiety, Dose of sedative drugs administered during the procedure
Medical subject headings
Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MusicOther

    A previously defined list of songs will be administered by headphones to these patients.

  • No musicOther

    No music will be administered by the headphones connected to the MP3 device.

Study groups in NCT01285284
Study groupRoleWhat they receive
MusicExperimentalA previously defined list of songs will be administered by headphones to these patients during the colonoscopy.
Receives: Other: Music
ControlSham comparatorThese patients will receive an MP3 device (and headphones) which will be functioning but without volume.
Receives: Other: No music

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The administered dose of midazolam

    The accumulated dose of midazolam administered during the procedure will be registered and compared between both arms.

    Measured: After colonoscopy is finished.

  2. Level of anxiety

    We will use a self-adminsitered questonary (STAI)

    Measured: rigth before colonoscopy and after it at the moment of discharge

Secondary outcomes (8)

  1. Evolution of vital signs

    Heart rate and blood pressure will be measured right before the colonoscopy, five and ten minutes after its start.

    Measured: Rigth before and during the colonoscopy

  2. Colonoscopy time

    The time elapsed since the beginning of the colonoscopy until its end.

    Measured: During the colonoscopy

  3. Patient's global evaluation of the procedure

    After the procedure the patient will evaluate the procedure as : a)Very Bad, b)Bad, c)Good, d)Very Good.

    Measured: after the colonoscopy at the moment of discharge.

  4. Time since the beginning of the procedure until the discharge

    The time elapsed since the beginning of the procedure until the discharge.

    Measured: since the beginning of the procedure until the discharge.

  5. How difficult the colonoscopy was?

    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.

    Measured: After the procedure.

  6. Adverse effects

    Every unexpected and adverse effect will be registered.

    Measured: Since the begining of the procedure until the discharge.

  7. The level of pain

    Using a Visual Analog Scale, the intensity of pain experimented during the colonoscopy will be evaluated after the procedure on both arms.

    Measured: After colonoscopy at the moment of discharge

  8. Willing of repeating the procedure.

    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.

    Measured: After colonoscopy at the moment of discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionSep 2011 (estimated)
  4. Study completionOct 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01285284
Sponsor's protocol ID
10-237
Acronym
EMOC
Status last verified
Mar 2011
First submitted
26 Jan 2011
Last updated
9 Aug 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Leung FW. Methods of reducing discomfort during colonoscopy. Dig Dis Sci. 2008 Jun;53(6):1462-7. doi: 10.1007/s10620-007-0025-9.

    PubMed 17999189

  • Costa A, Montalbano LM, Orlando A, Ingoglia C, Linea C, Giunta M, Mancuso A, Mocciaro F, Bellingardo R, Tine F, D'Amico G. Music for colonoscopy: A single-blind randomized controlled trial. Dig Liver Dis. 2010 Dec;42(12):871-6. doi: 10.1016/j.dld.2010.03.016. Epub 2010 May 7.

    PubMed 20452299

  • Bechtold ML, Perez RA, Puli SR, Marshall JB. Effect of music on patients undergoing outpatient colonoscopy. World J Gastroenterol. 2006 Dec 7;12(45):7309-12. doi: 10.3748/wjg.v12.i45.7309.

    PubMed 17143946

  • Harikumar R, Raj M, Paul A, Harish K, Kumar SK, Sandesh K, Asharaf S, Thomas V. Listening to music decreases need for sedative medication during colonoscopy: a randomized, controlled trial. Indian J Gastroenterol. 2006 Jan-Feb;25(1):3-5.

    PubMed 16567885

  • Ovayolu N, Ucan O, Pehlivan S, Pehlivan Y, Buyukhatipoglu H, Savas MC, Gulsen MT. Listening to Turkish classical music decreases patients' anxiety, pain, dissatisfaction and the dose of sedative and analgesic drugs during colonoscopy: a prospective randomized controlled trial. World J Gastroenterol. 2006 Dec 14;12(46):7532-6. doi: 10.3748/wjg.v12.i46.7532.

    PubMed 17167846

  • Tam WW, Wong EL, Twinn SF. Effect of music on procedure time and sedation during colonoscopy: a meta-analysis. World J Gastroenterol. 2008 Sep 14;14(34):5336-43. doi: 10.3748/wjg.14.5336.

    PubMed 18785289

  • Bechtold ML, Puli SR, Othman MO, Bartalos CR, Marshall JB, Roy PK. Effect of music on patients undergoing colonoscopy: a meta-analysis of randomized controlled trials. Dig Dis Sci. 2009 Jan;54(1):19-24. doi: 10.1007/s10620-008-0312-0. Epub 2008 May 16.

    PubMed 18483858

  • Rudin D, Kiss A, Wetz RV, Sottile VM. Music in the endoscopy suite: a meta-analysis of randomized controlled studies. Endoscopy. 2007 Jun;39(6):507-10. doi: 10.1055/s-2007-966362.

    PubMed 17554644

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Music and No music in people with Pain and Anxiety, run by Pontificia Universidad Catolica de Chile at 4 sites in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Carlos E Benítez, M.D. (56-02-3543820 ext. 3880, cbenitez@med.puc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The administered dose of midazolam (time frame: After colonoscopy is finished.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01285284, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2011.

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