Arthritis, RheumatoidNCT02436785
Do Inflammatory Arthritis Inpatients Receiving Group Music Therapy Improve Pain Compared to Music Listening?
A study testing Music Therapy and Music Listening in people with Arthritis, Rheumatoid and Spondylarthropathies, run by University of British Columbia at 1 site in Canada.
Trial summary
Pain management is rated by patients with inflammatory arthritis as the highest priority in their disease treatment. Past research showed that music therapy is associated with reduced pain and depression. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Arthritis, Rheumatoid, Spondylarthropathies, Arthritis, Psoriatic
- What is being tested?
- Music Therapy and Music Listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 6 May 2015to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of inflammatory arthritis
- Admission to G F Strong Rehabilitation Center Arthritis Inpatient Program from the community or after joint replacement surgery
- Between ages 16 and 85 years
- Can speak, read and write in English
Who cannot join
- Self-reported hearing loss
- Clinician judgement of being unable to follow directions
Trial locations and contacts
1 site in 1 country.
Canada1 site
G F Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
About this study
Official title: Do Inflammatory Arthritis Inpatients Receiving Group Music Therapy Improve Pain Compared to Music Listening Over the 4 Weeks Using a Randomised Control Trial?
Pain management is rated by patients with inflammatory arthritis as the highest priority in their disease treatment. Past research showed that music therapy is associated with reduced pain and depression. The purpose of this study is to better understand the effectiveness of music therapy for people with inflammatory arthritis. Participants will be randomly assigned to: 1) Music Therapy group facilitated by a music therapist, or 2) Music Listening group that listens to a relaxation CD (compact disc). Standardized tests will determine if participating in music therapy group helps reduce pain and depression, improve physical function and confidence levels in applying self-management strategies.
Read the detailed description
- Purpose: To better understand the effectiveness of music therapy for people with inflammatory arthritis. Determine if participating in a music therapy group facilitated by a music therapist helps reduce pain and depression, and improve physical function and self-efficacy. No optional studies are currently planned.
- Hypothesis Participants in the Music Therapy group will report less pain than those in the Music Listening group after the intervention phase. Music Therapy will also be associated with improvement in secondary outcomes including physical functioning, self-efficacy, and depression.
- Justification G F Strong Rehabilitation Center Arthritis Inpatient Program has an interdisciplinary approach to pain management: education, medical management, physiotherapy interventions such as exercises and use of physical agents (i.e. heat, cold, electrotherapy, ultrasound), occupational therapy intervention (i.e. activity modification and use of adaptive devices), and social work, dietician, psychology and pharmacy services. Current standard of care has limitations; it insufficiently addresses emotional aspects of chronic pain management. It also introduces relaxation strategies in a didactic module but does not provide training and opportunity to practice these strategies with the support of a health care professional. The Music Therapy intervention group is facilitated by a music therapist. Music therapists are trained to manipulate elements of music to achieve desired effects during music therapy interventions. These elements, such as beat, tempo (speed), or pitch level, can trigger adaptive neurophysiological, psychophysiological, emotional and behavioural responses. The Music Therapy group offers a chance to practice pain management and relaxation strategies, increase a sense of social cohesion and reduce a sense of isolation that individuals may experience when dealing with chronic pain. Participants in the control Music Listening group will listen to a relaxation CD. Past research showed that music therapy and music listening are associated with reduced pain intensity levels, increased functional mobility, and reduced depression. There was no clear research found on group music therapy's effectiveness on people with inflammatory arthritis. This feasibility study will help to better understand the effectiveness of music therapy for people with inflammatory arthritis.
- Objectives Outcome measures to be collected include:
- Category Rating Scale for Pain (from RAPID-3)
- Rheumatoid Arthritis Self-efficacy Scale (RASE)
- 6 Minute Walk Test (6MWT)
- Routine Assessment of Patient Index Data 3 (RAPID-3)
- Canadian Occupational Performance Measures (COPM)
- Center for Epidemiological Studies Depression Scale (CES-D) Data will be collected on three occasions: 1) time of enrollment, 2) after attending Music Therapy or Music Listening sessions, and 3) one month after completion of intervention.
- Research Method
- Target population: patients with inflammatory arthritis admitted to G F Strong Rehabilitation Center Inpatient Arthritis program
- Sampling method: participants will be stratified into 4 groups and randomized using a 1:1 allocation ratio into 2 groups: Music Therapy and Music Listening. 40 patients are expected to enroll during recruiting time from April to September in 2015.
- Research design: Parallel group feasibility randomized controlled trial with a dose-matched active comparator.
- Statistical Analysis Statistical software such as R, Minitab and Cytel Studio will be used to create descriptive statistics such as means and standard deviations; medians and interquartile ranges, minima, and maxima. A CONSORT flow chart will be constructed to show any losses during the trial, and imputation methods will be used to study the impact of missingness on any of the estimates and conclusions. Statistical models for each outcome variable will be used to measure the effect of Music Therapy compared to Music Listening group. Model assumptions such as independence of observations, normality of residuals and homogeneity of variance to validate the statistical analyses will be conducted.
- Being tested
- Music Therapy, Music Listening
- Keywords
- music therapy, pain management, self efficacy, patient education, relaxation
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthropathies, Arthritis, Psoriatic, Arthritis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
In-vivo relaxation where the live music is manipulated in terms of speed and intensity to bring on a state of relaxation for approximately an hour. There will be a brief therapist-led discussion before and after the relaxation portion to increase a sense of group cohesion. Procedures that will be used are based on evidence-based practice for trained Music Therapists.
Music ListeningOther
Listening to relaxing music on a CD player for approximately an hour.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy | Active comparator | The music therapy group will run for approximately an hour (twice a week) and will involve in-vivo relaxation where the live music is manipulated in terms of speed and intensity to bring on a state of relaxation. There will be a brief therapist-led discussion before and after the relaxation portion to increase a sense of group cohesion. Procedures that will be used are based on evidence-based practice for trained Music Therapists. Receives: Other: Music Therapy |
| Music Listening | Active comparator | The control group will also run for approximately an hour (twice a week) and will involve listening to relaxing music on a CD player. Receives: Other: Music Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scale rating (on Routine Assessment of Patient Index Data 3)
Numeric pain rating from 0 to 10 with 0.5 increment
Measured: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Secondary outcomes (11)
Rheumatoid Arthritis Self-efficacy Scale (RASE)
Self-reported questionnaire rating on self-efficacy in the areas of pain management, fatigue management, stress management, joint protection and management of activities of daily living.
Measured: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
6 Minute Walk Test (6MWT)
Objective measurement of walking endurance in 6 minutes.
Measured: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Routine Assessment of Patient Index Data 3 (RAPID-3)
Subjective questionnaire on performance level of activities of daily living.
Measured: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Canadian Occupational Performance Measures (COPM)
Subjective report on performance level of activities of daily living and self reported satisfaction level
Measured: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
self reported questionnaire on frequency of experiencing depression symptoms.
Measured: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Pain Scale rating (on Routine Assessment of Patient Index Data 3)
Numeric pain rating from 0 to 10 with 0.5 increment
Measured: one month after completion of intervention
Rheumatoid Arthritis Self-efficacy Scale (RASE)
Self-reported questionnaire rating on self-efficacy in the areas of pain
Measured: one month after completion of intervention
6 Minute Walk Test (6MWT)
Objective measurement of walking endurance in 6 minutes.
Measured: one month after completion of intervention
Routine Assessment of Patient Index Data 3 (RAPID-3)
Subjective questionnaire on performance level of activities of daily living.
Measured: one month after completion of intervention
Canadian Occupational Performance Measures (COPM)
self reported questionnaire on frequency of experiencing depression symptoms.
Measured: one month after completion of intervention
Center for Epidemiological Studies Depression Scale (CES-D)
self reported questionnaire on frequency of experiencing depression symptoms.
Measured: one month after completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study start6 May 2015
- Primary completion31 Dec 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Mary Pack Research Fund, Vancouver Coastal Health Research Institute
- Responsible party
- Principal investigator, Katherine Wright, University of British Columbia
- Investigators
- Katherine M Wright, MA, Principal investigator, G F Strong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436785
- Sponsor's protocol ID
- H14-03446
- Status last verified
- Jan 2019
- First submitted
- 8 Apr 2015
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Radner H, Ramiro S, Buchbinder R, Landewe RB, van der Heijde D, Aletaha D. Pain management for inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and other spondylarthritis) and gastrointestinal or liver comorbidity. Cochrane Database Syst Rev. 2012 Jan 18;1(1):CD008951. doi: 10.1002/14651858.CD008951.pub2.
PubMed 22258995Heiberg T, Kvien TK. Preferences for improved health examined in 1,024 patients with rheumatoid arthritis: pain has highest priority. Arthritis Rheum. 2002 Aug;47(4):391-7. doi: 10.1002/art.10515.
PubMed 12209485Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.
PubMed 16625614Garza-Villarreal EA, Wilson AD, Vase L, Brattico E, Barrios FA, Jensen TS, Romero-Romo JI, Vuust P. Music reduces pain and increases functional mobility in fibromyalgia. Front Psychol. 2014 Feb 11;5:90. doi: 10.3389/fpsyg.2014.00090. eCollection 2014.
PubMed 24575066Siedliecki SL, Good M. Effect of music on power, pain, depression and disability. J Adv Nurs. 2006 Jun;54(5):553-62. doi: 10.1111/j.1365-2648.2006.03860.x.
PubMed 16722953Bagheri-Nesami M, Mohseni-Bandpei MA, Shayesteh-Azar M. The effect of Benson Relaxation Technique on rheumatoid arthritis patients: extended report. Int J Nurs Pract. 2006 Aug;12(4):214-9. doi: 10.1111/j.1440-172X.2006.00568.x.
PubMed 16834582Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.
PubMed 22001666Dager TN, Kjeken I, Fjerstad E, Hauge MI. "It is about taking grips and not let myself be ravaged by my body": a qualitative study of outcomes from in-patient multidisciplinary rehabilitation for patients with chronic rheumatic diseases. Disabil Rehabil. 2012;34(11):910-6. doi: 10.3109/09638288.2011.626485. Epub 2011 Nov 8.
PubMed 22066740Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
PubMed 20053272
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Inflammatory Arthritis Inpatients Receiving Group Music Therapy Improve Pain Compared to Music Listening Over the 4 Weeks Using a Randomised Control Trial?
- ClinicalTrials.gov ID
- NCT02436785
- Acronym / sponsor ID
- H14-03446
- Keywords
- music therapy, pain management, self efficacy, patient education, relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Mary Pack Research Fund, Vancouver Coastal Health Research Institute
- Study start
- 6 May 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 7 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pain management is rated by patients with inflammatory arthritis as the highest priority in their disease treatment. Past research showed that music therapy is associated with reduced pain and depression. The purpose of this study is to better understand the effectiveness of music therapy for people with inflammatory arthritis. Participants will be randomly assigned to: 1) Music Therapy group facilitated by a music therapist, or 2) Music Listening group that listens to a relaxation CD (compact disc). Standardized tests will determine if participating in music therapy group helps reduce pain and depression, improve physical function and confidence levels in applying self-management strategies.
Detailed description
- Purpose: To better understand the effectiveness of music therapy for people with inflammatory arthritis. Determine if participating in a music therapy group facilitated by a music therapist helps reduce pain and depression, and improve physical function and self-efficacy. No optional studies are currently planned.
- Hypothesis Participants in the Music Therapy group will report less pain than those in the Music Listening group after the intervention phase. Music Therapy will also be associated with improvement in secondary outcomes including physical functioning, self-efficacy, and depression.
- Justification G F Strong Rehabilitation Center Arthritis Inpatient Program has an interdisciplinary approach to pain management: education, medical management, physiotherapy interventions such as exercises and use of physical agents (i.e. heat, cold, electrotherapy, ultrasound), occupational therapy intervention (i.e. activity modification and use of adaptive devices), and social work, dietician, psychology and pharmacy services. Current standard of care has limitations; it insufficiently addresses emotional aspects of chronic pain management. It also introduces relaxation strategies in a didactic module but does not provide training and opportunity to practice these strategies with the support of a health care professional. The Music Therapy intervention group is facilitated by a music therapist. Music therapists are trained to manipulate elements of music to achieve desired effects during music therapy interventions. These elements, such as beat, tempo (speed), or pitch level, can trigger adaptive neurophysiological, psychophysiological, emotional and behavioural responses. The Music Therapy group offers a chance to practice pain management and relaxation strategies, increase a sense of social cohesion and reduce a sense of isolation that individuals may experience when dealing with chronic pain. Participants in the control Music Listening group will listen to a relaxation CD. Past research showed that music therapy and music listening are associated with reduced pain intensity levels, increased functional mobility, and reduced depression. There was no clear research found on group music therapy's effectiveness on people with inflammatory arthritis. This feasibility study will help to better understand the effectiveness of music therapy for people with inflammatory arthritis.
- Objectives Outcome measures to be collected include:
- Category Rating Scale for Pain (from RAPID-3)
- Rheumatoid Arthritis Self-efficacy Scale (RASE)
- 6 Minute Walk Test (6MWT)
- Routine Assessment of Patient Index Data 3 (RAPID-3)
- Canadian Occupational Performance Measures (COPM)
- Center for Epidemiological Studies Depression Scale (CES-D) Data will be collected on three occasions: 1) time of enrollment, 2) after attending Music Therapy or Music Listening sessions, and 3) one month after completion of intervention.
- Research Method
- Target population: patients with inflammatory arthritis admitted to G F Strong Rehabilitation Center Inpatient Arthritis program
- Sampling method: participants will be stratified into 4 groups and randomized using a 1:1 allocation ratio into 2 groups: Music Therapy and Music Listening. 40 patients are expected to enroll during recruiting time from April to September in 2015.
- Research design: Parallel group feasibility randomized controlled trial with a dose-matched active comparator.
- Statistical Analysis Statistical software such as R, Minitab and Cytel Studio will be used to create descriptive statistics such as means and standard deviations; medians and interquartile ranges, minima, and maxima. A CONSORT flow chart will be constructed to show any losses during the trial, and imputation methods will be used to study the impact of missingness on any of the estimates and conclusions. Statistical models for each outcome variable will be used to measure the effect of Music Therapy compared to Music Listening group. Model assumptions such as independence of observations, normality of residuals and homogeneity of variance to validate the statistical analyses will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Active comparator | Other: Music TherapyThe music therapy group will run for approximately an hour (twice a week) and will involve in-vivo relaxation where the live music is manipulated in terms of speed and intensity to bring on a state of relaxation. There will be a brief therapist-led discussion before and after the relaxation portion to increase a sense of group cohesion. Procedures that will be used are based on evidence-based practice for trained Music Therapists. |
| Music Listening | Active comparator | Other: Music ListeningThe control group will also run for approximately an hour (twice a week) and will involve listening to relaxing music on a CD player. |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of inflammatory arthritis
- Admission to G F Strong Rehabilitation Center Arthritis Inpatient Program from the community or after joint replacement surgery
- Between ages 16 and 85 years
- Can speak, read and write in English
Key exclusion criteria (2 listed)
- Self-reported hearing loss
- Clinician judgement of being unable to follow directions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyIn-vivo relaxation where the live music is manipulated in terms of speed and intensity to bring on a state of relaxation for approximately an hour. There will be a brief therapist-led discussion before and after the relaxation portion to increase a sense of group cohesion. Procedures that will be used are based on evidence-based practice for trained Music Therapists. | Other | Music Therapy |
| Music ListeningListening to relaxing music on a CD player for approximately an hour. | Other | Music Listening |
Primary outcome
Pain Scale rating (on Routine Assessment of Patient Index Data 3)
Time frame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Numeric pain rating from 0 to 10 with 0.5 increment
11 secondary outcomes
Rheumatoid Arthritis Self-efficacy Scale (RASE)
Time frame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
6 Minute Walk Test (6MWT)
Time frame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Routine Assessment of Patient Index Data 3 (RAPID-3)
Time frame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Canadian Occupational Performance Measures (COPM)
Time frame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks
Pain Scale rating (on Routine Assessment of Patient Index Data 3)
Time frame: one month after completion of intervention
Rheumatoid Arthritis Self-efficacy Scale (RASE)
Time frame: one month after completion of intervention
6 Minute Walk Test (6MWT)
Time frame: one month after completion of intervention
Routine Assessment of Patient Index Data 3 (RAPID-3)
Time frame: one month after completion of intervention
Canadian Occupational Performance Measures (COPM)
Time frame: one month after completion of intervention
Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: one month after completion of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Background: PubMed 22258995Radner H, Ramiro S, Buchbinder R, Landewe RB, van der Heijde D, Aletaha D. Pain management for inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and other spondylarthritis) and gastrointestinal or liver comorbidity. Cochrane Database Syst Rev. 2012 Jan 18;1(1):CD008951. doi: 10.1002/14651858.CD008951.pub2.
- Background: PubMed 12209485Heiberg T, Kvien TK. Preferences for improved health examined in 1,024 patients with rheumatoid arthritis: pain has highest priority. Arthritis Rheum. 2002 Aug;47(4):391-7. doi: 10.1002/art.10515.
- Background: PubMed 16625614Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.
- Background: PubMed 24575066Garza-Villarreal EA, Wilson AD, Vase L, Brattico E, Barrios FA, Jensen TS, Romero-Romo JI, Vuust P. Music reduces pain and increases functional mobility in fibromyalgia. Front Psychol. 2014 Feb 11;5:90. doi: 10.3389/fpsyg.2014.00090. eCollection 2014.
- Background: PubMed 16722953Siedliecki SL, Good M. Effect of music on power, pain, depression and disability. J Adv Nurs. 2006 Jun;54(5):553-62. doi: 10.1111/j.1365-2648.2006.03860.x.
- Background: PubMed 16834582Bagheri-Nesami M, Mohseni-Bandpei MA, Shayesteh-Azar M. The effect of Benson Relaxation Technique on rheumatoid arthritis patients: extended report. Int J Nurs Pract. 2006 Aug;12(4):214-9. doi: 10.1111/j.1440-172X.2006.00568.x.
- Background: PubMed 22001666Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.
- Background: PubMed 22066740Dager TN, Kjeken I, Fjerstad E, Hauge MI. "It is about taking grips and not let myself be ravaged by my body": a qualitative study of outcomes from in-patient multidisciplinary rehabilitation for patients with chronic rheumatic diseases. Disabil Rehabil. 2012;34(11):910-6. doi: 10.3109/09638288.2011.626485. Epub 2011 Nov 8.
- Background: PubMed 20053272Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine M Wright, MA principal investigator
G F Strong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy and Music Listening in people with Arthritis, Rheumatoid and Spondylarthropathies, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scale rating (on Routine Assessment of Patient Index Data 3) (time frame: after attending 8 Music Therapy or Music Listening sessions over 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02436785, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.