UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027011 |
|---|---|
| Receipt number | 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 02:54:20 |
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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
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
jmoyano@unbosque.edu.co
Sponsor or person
Institute
University Hospital Fundacion Santa Fe de Bogota
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030971
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
