NCT01285284

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_4 pain

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

August 9, 2011

Status Verified

March 1, 2011

Enrollment Period

6 months

First QC Date

January 26, 2011

Last Update Submit

August 8, 2011

Conditions

PainAnxiety

Keywords

ColonoscopyMusicTolerancePainAnxietyDose of sedative drugs administered during the procedure

Outcome Measures

Primary Outcomes (2)

  • The administered dose of midazolam

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

    After colonoscopy is finished.

  • Level of anxiety

    We will use a self-adminsitered questonary (STAI)

    rigth before colonoscopy and after it at the moment of discharge

Secondary Outcomes (8)

  • Evolution of vital signs

    Rigth before and during the colonoscopy

  • Colonoscopy time

    During the colonoscopy

  • Patient's global evaluation of the procedure

    after the colonoscopy at the moment of discharge.

  • Time since the beginning of the procedure until the discharge

    since the beginning of the procedure until the discharge.

  • How difficult the colonoscopy was?

    After the procedure.

  • +3 more secondary outcomes

Study Arms (2)

Music

EXPERIMENTAL

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

Other: Music

Control

SHAM COMPARATOR

These patients will receive an MP3 device (and headphones) which will be functioning but without volume.

Other: No music

Interventions

MusicOTHER

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

Music
No musicOTHER

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Provicial Dr. Rafael Avaria Valenzuela

Curanilahue, Región del Biobío, 444444, Chile

RECRUITING

Centro Médico UC San Joaquín

Santiago, RM, 8320000, Chile

RECRUITING

Hospital Clínico. Pontificia Universidad Católica de Chile

Santiago, RM, 8330024, Chile

RECRUITING

Clínica UC San Carlos de Apoquindo

Santiago, Santiago Metropolitan, 8320000, Chile

RECRUITING

Related Publications (8)

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

    PMID: 17999189BACKGROUND

  • 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.

    PMID: 20452299BACKGROUND

  • 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.

    PMID: 17143946BACKGROUND

  • 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.

    PMID: 16567885BACKGROUND

  • 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.

    PMID: 17167846BACKGROUND

  • 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.

    PMID: 18785289BACKGROUND

  • 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.

    PMID: 18483858BACKGROUND

  • 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.

    PMID: 17554644BACKGROUND

MeSH Terms

Conditions

PainAnxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Carlos E Benítez, M.D.

    Gastroenterology Department. Pontificia Universidad Católica de Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos E Benítez, M.D.

CONTACT

56-02-3543820cbenitez@med.puc.cl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 27, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

August 9, 2011

Record last verified: 2011-03

Locations

CL(4)