UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027011
Receipt No. R000030971
Scientific 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
Date of disclosure of the study information 2017/12/31
Last modified on 2017/04/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public 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
Acronym 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
Scientific 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Jairo R Moyano
Organization University Hospital Fundacion Santa Fe de Bogota
Division name Pain Clinic
Zip code
Address Calle 119#7-75
TEL 5716030303
Email jmoyano@unbosque.edu.co

Public contact
Name of contact person
1st name
Middle name
Last name Jairo R Moyano
Organization University Hospital Fundacion Santa Fe de Bogota
Division name Pain Clinic
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 02 Month 08 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.