Effect of Music Over the Tolerance to Colonoscopy.

NCT ID: NCT01285284

Last Updated: 2011-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-10-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Music

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

Group Type: EXPERIMENTAL

Music

Intervention Type: OTHER

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

Control

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

Group Type: SHAM_COMPARATOR

No music

Intervention Type: OTHER

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

Interventions

Music

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

Intervention Type: OTHER

No music

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clínica UC San Carlos de Apoquindo.

UNKNOWN

Sponsor Role: collaborator

Hospital Provicial Dr. Rafael Avaria Valenzuela

UNKNOWN

Sponsor Role: collaborator

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Gastroenterology Department, Hospital Clínico de la Pontificia Universidad Católica de Chile

Principal Investigators

Carlos E Benítez, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology Department. Pontificia Universidad Católica de Chile

Locations

Hospital Provicial Dr. Rafael Avaria Valenzuela

Curanilahue, Región del Biobío, Chile

Site Status: RECRUITING

Centro Médico UC San Joaquín

Santiago, RM, Chile

Site Status: RECRUITING

Hospital Clínico. Pontificia Universidad Católica de Chile

Santiago, RM, Chile

Site Status: RECRUITING

Clínica UC San Carlos de Apoquindo

Santiago, Santiago Metropolitan, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Carlos E Benítez, M.D.

Role: CONTACT

cbenitez@med.puc.cl

56-02-3543820 ext. 3880

Facility Contacts

Andrés Jorquera, M.D.

Role: primary

aajorque@gmail.com

56-41-2725480

Eugenia Morales, M.D.

Role: primary

nonoymorales@gmail.com

354 8500 ext. 3333

Luis Méndez, M.D.

Role: primary

lucciomendez@gmail.com

56-02-3543820 ext. 3880

Arnoldo Riquelme, M.D.

Role: primary

arnoldoriquelme@gmail.com

56-45-7548700

References

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

Reference Type: BACKGROUND

PMID: 17999189 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20452299 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17143946 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16567885 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17167846 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18785289 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18483858 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17554644 (View on PubMed)

Other Identifiers

10-237

Identifier Type: -

Identifier Source: org_study_id