UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Use of Musicotherapy as a Periprocedural Tool to Lower anxiety and Raise Satisfaction in Patients with Chronic Low Back Pain During Interventional Pain Management at a University Hospital in Bogota, Colombia
Title of the study (Brief title)	Use of Musicotherapy as a Periprocedural Tool to Lower anxiety and Raise Satisfaction in Patients with Chronic Low Back Pain During Interventional Pain Management at a University Hospital in Bogota, Colombia
Region	South America

Condition
Condition	Chronic low back pain
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To know if exposure to patient selected music diminishes anxiety levels and increases periprocedural satisfaction in patients with chronic low back pain, older than 40 years old in whom interventional pain management is done in a university hospital in Bogota, Colombia
Basic objectives2	Others
Basic objectives -Others	Determine anxiety levels before, during and after the intervention
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Music exposure reduce anxiety leves and increases patients satisfaction
Key secondary outcomes	Analyse results and design protocols of musicotherapy in different surgical and anesthetic procedures. Extrapolate results to different populations.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Patients listen to music of their preference 15 minutes before procedure
Interventions/Control_2	Patients listen to music of their preference 15 minutes before procedure, during the procedure and 15 minutes after it has ended
Interventions/Control_3	Patients don't listen to music at all
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Chronic Low Back Pain, Older than 40 years old, no previous interventionist low back pain treatment, no candidate for back surgery, patients capable of deciding, communicating and understanding aims and objectives of the study.
Key exclusion criteria	Younger than 40 years, previous interventionist pain treatment or back surgery, severe hearing impairment
Target sample size	80

Research contact person
Name of lead principal investigator	Jairo R Moyano
Organization	University Hospital Fundacion Santa Fe de Bogota
Division name	Pain Clinic
Address	Calle 119#7-75
TEL	5716030303
Email	jmoyano@unbosque.edu.co

Public contact
Name of contact person	Jairo R Moyano
Organization	University Hospital Fundacion Santa Fe de Bogota
Division name	Pain Clinic
Address	Calle 119#7-75
TEL	5716030303
Homepage URL
Email	jmoyano@unbosque.edu.co

Sponsor
Institute	University Hospital Fundacion Santa Fe de Bogota
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	University Hospital Fundacion Santa Fe de Bogota

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 31 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 02 Month 08 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2017 Year 04 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 17 Day
Last modified on	2017 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030971