Clinical trial NCT01285284: Effect of Music Over the Tolerance to Colonoscopy.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Anxiety
Keywords: Colonoscopy
Music
Tolerance
Pain
Anxiety
Dose of sedative drugs administered during the procedure
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Clínica UC San Carlos de Apoquindo.
name: Hospital Provicial Dr. Rafael Avaria Valenzuela
First posted: 2011-01-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The administered dose of midazolam
timeFrame: After colonoscopy is finished.
measure: Level of anxiety
timeFrame: rigth before colonoscopy and after it at the moment of discharge
Secondary outcomes:
measure: Evolution of vital signs
timeFrame: Rigth before and during the colonoscopy
measure: Colonoscopy time
timeFrame: During the colonoscopy
measure: Patient's global evaluation of the procedure
timeFrame: after the colonoscopy at the moment of discharge.
measure: Time since the beginning of the procedure until the discharge
timeFrame: since the beginning of the procedure until the discharge.
measure: How difficult the colonoscopy was?
timeFrame: After the procedure.
measure: Adverse effects
timeFrame: Since the begining of the procedure until the discharge.
measure: The level of pain
timeFrame: After colonoscopy at the moment of discharge
measure: Willing of repeating the procedure.
timeFrame: After colonoscopy at the moment of discharge
Other outcomes:
Locations:
city: Curanilahue
country: Chile
facility: Hospital Provicial Dr. Rafael Avaria Valenzuela
state: Octava Región
city: Santiago
country: Chile
facility: Clínica UC San Carlos de Apoquindo
state: Región Metropolitana
city: Santiago
country: Chile
facility: Centro Médico UC San Joaquín
state: RM
city: Santiago
country: Chile
facility: Hospital Clínico. Pontificia Universidad Católica de Chile
state: RM
Study officials:
affiliation: Gastroenterology Department. Pontificia Universidad Católica de Chile
name: Carlos E Benítez, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leung FW. Methods of reducing discomfort during colonoscopy. Dig Dis Sci. 2008 Jun;53(6):1462-7. doi: 10.1007/s10620-007-0025-9.
citation: 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.
citation: 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.
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.
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. doi: 10.3748/wjg.v12.i46.7532.
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. doi: 10.3748/wjg.14.5336.
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.
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. doi: 10.1055/s-2007-966362.