Effect of Music Over the Tolerance to Colonoscopy.

Pain Clinical Trial

— EMOC  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01285284
• Other study ID #: 10-237
• Status: Recruiting
• Phase: Phase 4
• First received: January 26, 2011
• Last updated: August 8, 2011
• Start date: March 2011
• Est. completion date: October 2011

Study information

• Verified date: March 2011
• Source: Pontificia Universidad Catolica de Chile
• Contact: Carlos E Benítez, M.D.
• Phone: 56-02-3543820
• Email: cbenitez[@]med.puc.cl
• Is FDA regulated: No
• Health authority: Chile: Comité de Ética del Hospital Clínico de la Pontificia Universidad Católica de Chile
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

Other:
• Music
A previously defined list of songs will be administered by headphones to these patients.
• No music
No music will be administered by the headphones connected to the MP3 device.

Locations

Country	Name	City	State
Chile	Hospital Provicial Dr. Rafael Avaria Valenzuela	Curanilahue	Octava Región
Chile	Centro Médico UC San Joaquín	Santiago	RM
Chile	Clínica UC San Carlos de Apoquindo	Santiago	Región Metropolitana
Chile	Hospital Clínico. Pontificia Universidad Católica de Chile	Santiago	RM

Sponsors (3)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	Clínica UC San Carlos de Apoquindo., Hospital Provicial Dr. Rafael Avaria Valenzuela

Country where clinical trial is conducted

Chile, 

References & Publications (8)

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. — View Citation

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. Review. — View Citation

Costa A, Montalbano LM, Orlando A, Ingoglia C, Linea C, Giunta M, Mancuso A, Mocciaro F, Bellingardo R, Tinè 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. — View Citation

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. — View Citation

Leung FW. Methods of reducing discomfort during colonoscopy. Dig Dis Sci. 2008 Jun;53(6):1462-7. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	Level of anxiety	We will use a self-adminsitered questonary (STAI)	rigth before colonoscopy and after it at the moment of discharge	No
Secondary	Evolution of vital signs	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	No
Secondary	Colonoscopy time	The time elapsed since the beginning of the colonoscopy until its end.	During the colonoscopy	No
Secondary	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.	after the colonoscopy at the moment of discharge.	No
Secondary	Time 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.	No
Secondary	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.	After the procedure.	No
Secondary	Adverse effects	Every unexpected and adverse effect will be registered.	Since the begining of the procedure until the discharge.	Yes
Secondary	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.	After colonoscopy at the moment of discharge	No
Secondary	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.	After colonoscopy at the moment of discharge	No