Sickle Cell DiseaseNCT02270060
Music Therapy in Sickle Cell Pain Mixed Methods Study
A study testing Music Therapy and Music Listening in people with Sickle Cell Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to: 1. Investigate the effects of a single 20-minute music therapy intervention with a music therapist on the pain intensity, pain relief, and mood of adult patients with sickle cell disease as compared to: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Music Therapy and Music Listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have a diagnosis of sickle cell disease (HbSS, HbSC, HbSbeta+thal, or HbSbeta0thal)
- 18 years or older
- Able to speak and understand English
Who cannot join
- Patients who have significant hearing impairments and/or significant visual impairments that have not been corrected
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Seidman Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: The Effects of a Single Music Therapy Session on the Pain of Adult Patients With Sickle Cell Disease: A Mixed Methods Study
The purpose of this research study is to:
- Investigate the effects of a single 20-minute music therapy intervention with a music therapist on the pain intensity, pain relief, and mood of adult patients with sickle cell disease as compared to:
- Adult patients with SCD who listen to their preferred music for 20 minutes without the presence of a music therapist (music listening group)
- Adult patients with SCD who receive standard care alone (control group)
- Determine the feasibility (delivery, acceptability, and usefulness) of the music therapy intervention for pain management
- Conditions
- Sickle Cell Disease
- Being tested
- Music Therapy, Music Listening
- Keywords
- Music Therapy, Sickle Cell Disease, Pain
- Medical subject headings
- Anemia, Sickle Cell, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.
Music ListeningOther
Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy Group | Experimental | Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad. Receives: Other: Music Therapy |
| Music Listening Group | Active comparator | Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist. Receives: Other: Music Listening |
| Control Group | No intervention | Patient receives standard care and waits in treatment room/bay for twenty minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card
Visual analog scale of pain intensity. The minimum score is 0. The maximum score is 10. Higher scores represent worse pain intensity.
Measured: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Secondary outcomes (6)
Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card
Visual analog scale of Pain Relief. The minimum score is 0. The maximum score is 10. Higher scores represent greater pain relief.
Measured: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card
Visual analog scale of mood. The minimum score is 0. The maximum score is 10. Higher scores represent better mood.
Measured: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card
Pain adjectives scale. The minimum score is 1. The maximum score is 7. Higher scores represent worse pain.
Measured: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Length of Stay in Minutes
Length of stay (in minutes) in acute care clinic
Measured: From time of admission into acute care clinic to time of discharge, up to 8 hours.
Amount of Hydromorphone
Amount of Hydromorphone received in acute care clinic following intervention
Measured: From time of admission into acute care clinic to time of discharge, up to 8 hours.
Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR)
Numeric pain rating between 0-10 before and after admission to acute care clinic. The minimum score is 0. The maximum score is 10. Higher scores represent worse pain.
Measured: From time of admission into acute care clinic to time of discharge, up to 8 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kulas Foundation
- Responsible party
- Principal investigator, Samuel Rodgers-Melnick, University Hospitals Cleveland Medical Center
- Investigators
- Samuel N Rodgers-Melnick, MT-BC, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270060
- Sponsor's protocol ID
- 08-14-11
- Status last verified
- Aug 2019
- First submitted
- 10 Oct 2014
- Last updated
- 21 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Guetin 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 22001666
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Single Music Therapy Session on the Pain of Adult Patients With Sickle Cell Disease: A Mixed Methods Study
- ClinicalTrials.gov ID
- NCT02270060
- Acronym / sponsor ID
- 08-14-11
- Conditions
- Sickle Cell Disease
- Keywords
- Music Therapy, Sickle Cell Disease, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Kulas Foundation
- Study start
- Sep 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Posted 15 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to:
- Investigate the effects of a single 20-minute music therapy intervention with a music therapist on the pain intensity, pain relief, and mood of adult patients with sickle cell disease as compared to:
- Adult patients with SCD who listen to their preferred music for 20 minutes without the presence of a music therapist (music listening group)
- Adult patients with SCD who receive standard care alone (control group)
- Determine the feasibility (delivery, acceptability, and usefulness) of the music therapy intervention for pain management
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Music Therapy Group | Experimental | Other: Music TherapyPatient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad. |
| Music Listening Group | Active comparator | Other: Music ListeningPatient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist. |
| Control Group | No intervention | –Patient receives standard care and waits in treatment room/bay for twenty minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who have a diagnosis of sickle cell disease (HbSS, HbSC, HbSbeta+thal, or HbSbeta0thal)
- 18 years or older
- Able to speak and understand English
Key exclusion criteria (1 listed)
- Patients who have significant hearing impairments and/or significant visual impairments that have not been corrected
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 TherapyPatient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad. | Other | Music Therapy Group |
| Music ListeningPatient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist. | Other | Music Listening Group |
Primary outcome
Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card
Time frame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Visual analog scale of pain intensity. The minimum score is 0. The maximum score is 10. Higher scores represent worse pain intensity.
6 secondary outcomes
Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card
Time frame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card
Time frame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card
Time frame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization
Length of Stay in Minutes
Time frame: From time of admission into acute care clinic to time of discharge, up to 8 hours.
Amount of Hydromorphone
Time frame: From time of admission into acute care clinic to time of discharge, up to 8 hours.
Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR)
Time frame: From time of admission into acute care clinic to time of discharge, up to 8 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Samuel N Rodgers-Melnick, MT-BC principal investigator
University Hospitals Cleveland Medical Center
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 Sickle Cell Disease, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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 3 inclusion and 1 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 21 Aug 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card (time frame: Baseline and at end of 20-minute intervention, up to 120 minutes following randomization). 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 NCT02270060, which also lists 1 linked publication.
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 21 Aug 2019.