Effect of Music Over the Tolerance to Colonoscopy.
- Conditions
- PainAnxiety
- Interventions
- Other: No musicOther: Music
- Registration Number
- NCT01285284
- Lead Sponsor
- Pontificia Universidad Catolica de Chile
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- Adults (over 18 years)
- Diagnostic colonoscopy
- Signed informed consent
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control No music These patients will receive an MP3 device (and headphones) which will be functioning but without volume. Music Music A previously defined list of songs will be administered by headphones to these patients during the colonoscopy.
- Primary Outcome Measures
Name Time Method The administered dose of midazolam After colonoscopy is finished. The accumulated dose of midazolam administered during the procedure will be registered and compared between both arms.
Level of anxiety rigth before colonoscopy and after it at the moment of discharge We will use a self-adminsitered questonary (STAI)
- Secondary Outcome Measures
Name Time Method Colonoscopy time During the colonoscopy The time elapsed since the beginning of the colonoscopy until its end.
Time since the beginning of the procedure until the discharge since the beginning of the procedure until the discharge. The time elapsed since the beginning of the procedure until the discharge.
Patient's global evaluation of the procedure after the colonoscopy at the moment of discharge. After the procedure the patient will evaluate the procedure as : a)Very Bad, b)Bad, c)Good, d)Very Good.
Willing of repeating the procedure. After colonoscopy at the moment of discharge 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.
How difficult the colonoscopy was? After the procedure. 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.
Adverse effects Since the begining of the procedure until the discharge. Every unexpected and adverse effect will be registered.
The level of pain After colonoscopy at the moment of discharge Using a Visual Analog Scale, the intensity of pain experimented during the colonoscopy will be evaluated after the procedure on both arms.
Evolution of vital signs Rigth before and during the colonoscopy Heart rate and blood pressure will be measured right before the colonoscopy, five and ten minutes after its start.
Trial Locations
- Locations (4)
Hospital Clínico. Pontificia Universidad Católica de Chile
🇨🇱Santiago, RM, Chile
Clínica UC San Carlos de Apoquindo
🇨🇱Santiago, Región Metropolitana, Chile
Hospital Provicial Dr. Rafael Avaria Valenzuela
🇨🇱Curanilahue, Octava Región, Chile
Centro Médico UC San Joaquín
🇨🇱Santiago, RM, Chile