Sickle Cell DiseaseNCT07222475
Writing Relaxing Beats in Adolescents Who Have Sickle Cell Disease
A study testing Songwriting intervention (active music therapy) in people with Sickle Cell Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
This research aims to see if songwriting can help reduce anxiety in adolescents with Sickle Cell Disease. The purpose of the study is to discover if participants find songwriting and playing their songs to be practical and acceptable, and helpful for managing anxiety. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Songwriting intervention (active music therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents aged 11-18 years of age at the time of enrollment and able to provide assent
- Diagnosed with any type of sickle cell disease
- Currently receiving care at pediatric center
- Able to read and write in English
Who cannot join
- Care transitioned to adult facility
- Visual, hearing, or cognitive impairment which may impede the ability to complete the songwriting intervention or data collection measures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
C. Robert Bennett contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Division of Nursing
Rochester, Minnesota, 55905
Pam Peterson, 507-422-5523
About this study
This research aims to see if songwriting can help reduce anxiety in adolescents with Sickle Cell Disease. The purpose of the study is to discover if participants find songwriting and playing their songs to be practical and acceptable, and helpful for managing anxiety.
- Conditions
- Sickle Cell Disease
- Being tested
- Songwriting intervention (active music therapy)
- Keywords
- Music Therapy
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Songwriting intervention (active music therapy)Behavioural
Participants will engage in a songwriting intervention with a music therapist.
| Study group | Role | What they receive |
|---|---|---|
| Active Music Therapy | Experimental | Songwriting intervention Receives: Behavioral: Songwriting intervention (active music therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State-Trait Anxiety Inventory score
The State and Trait Anxiety Inventory measures anxiety. Participants respond to 20 questions about how they are currently feeling on a 4-point Likert scale of 1 (not at all) to 4 (very much so). A total score is calculated by summing the item responses and ranges from 20 to 80. Higher scores indicate higher anxiety (a worse outcome) and lower scores indicate less anxiety (a better outcome).
Measured: Baseline, 3 months
Change in Patient Health Questionnaire (PHQ-A) score Change in Patient Health Questionnaire for Adolescents (PHQ-A) score
The Patient Health Questionnaire for Adolescents (PHQ-A) is a modified version of the PHQ-9 to be used with adolescents. Participants respond to 9 questions scored on a 4-point Likert scale of 0 (Not at all) to 3 (Nearly every day). A total score is calculated by summing the item responses and ranges from 0 to 27; higher scores are associated with higher levels of or more severe depression.
Measured: Baseline, 3 months
Change in Connor Davidson Resilience Scale (CD-RISC 10) score
The Connor-Davidson Resilience scale (CD-RISC) measures resilience. Participants respond to 10 questions scored on a 5-point Likert scale of 0 (Not true at all) to 4 (True nearly all the time). A total score is calculated by summing the item responses and ranges from 0 to 40; with higher scores reflecting greater resilience.
Measured: Baseline, 3 months
Change in Difficulties in Emotion Regulation Scale (DERS-SF) score
The Difficulties in Emotion Regulation Scale Short Form (DERS-SF) measures difficulties in emotion regulation in adults and adolescents. It consists of six subscales: Nonacceptance, Goals, Impulse, Awareness, Strategies, and Clarity, each with three items. Participants respond to 18 questions scored on a 5-point Likert scale of 1 (Almost never) to 5 (Almost always). A total score is calculating by summing the item responses and ranges from 18 to 90; higher scores indicate greater difficulty with emotion regulation skills.
Measured: Baseline, 3 months
Change in PROMIS Pediatric Pain Behavior (SF-8a) score
The PROMIS Pediatric Pain Behavior (SF-8a) short form measures behaviors that typically indicate to others that an individual is experiencing pain. Participants respond to 8 questions scored on a 6-point Likert scale of 1 (Had no pain) to 6 (Almost always). A total score is calculated by summing the item responses and ranges from 8 to 48, with higher scores indicating a more pain related behavior.
Measured: Baseline, 3 months
Change in PROMIS Pediatric Pain Quality - Affective (SF-8a) score
The PROMIS Pediatric Pain Quality- Affective (SF-8a) short form assesses the emotional distress that accompanies pain. Participants respond to 8 yes or no questions (0 = no, 1 = yes). A total score is calculated by summing the item responses and ranges from 0 to 8, with higher scores indicating a greater impact of pain on emotional distress.
Measured: Baseline, 3 months
Change in PROMIS Pediatric Pain Quality - Sensory (SF-8a) score
The PROMIS Pediatric Pain Quality - Sensory (SF-8a) short form assesses the sensory experiences of pain. Participants respond to 8 questions scored on a 5-point Likert scale of 1 (Not at all) to 5 (Very much). A total score is calculated by summing the item responses and ranges from 8 to 40, with higher scores indicating participants experiencing increased sensory responses to pain.
Measured: Baseline, 3 months
Change in PROMIS Pediatric Physical Stress Experiences (SF-8a) score
The PROMIS Pediatric Physical Stress Experiences (SF-8a) short form assess the physically experienced sensations associated with pain. Participants respond to 8 questions scored on a 5-point Likert scale of 1 (Never) to 5 (Always). A total score is calculated by summing the item responses and ranges from 8 to 40, with higher scores indicating a greater impact of pain on physical stress experienced.
Measured: Baseline, 3 months
Change in PROMIS Pediatric Psychological Stress Experience (SF) score
The PROMIS Pediatric Psychological Stress Experience (SF) short form assesses the thoughts and feelings associated with pain. It measures facets of stress, including feeling overwhelmed, lack of perceived control, and cognitive-perceptual disruption, using a 7-day recall period. Participants respond to 8 questions scored on a 5-point Likert scale of 1 (Never) to 5 (Always). A total score is calculated by summing the item responses and ranges from 8 to 40, with higher scores indicating a greater impact of pain on psychological stress.
Measured: Baseline, 3 months
Change in PROMIS Pediatric Physical Activity (SF) score
The PROMIS Pediatric Physical Activity (SF) measure self-reported capability of physical activities. Participants respond to 8 questions scored on a 5-point Likert scale of 0 (No days) to 5 (6-7 days). A total score is calculated by summing item responses and ranges from 0 to 40, with higher scores indicating a greater deal of physical activity.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start5 Feb 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, C. Robert Bennett, Mayo Clinic
- Investigators
- C. Robert Bennett, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222475
- Sponsor's protocol ID
- 24-007609
- Status last verified
- Feb 2026
- First submitted
- 27 Oct 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Writing Relaxing Beats in Adolescents Who Have Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT07222475
- Acronym / sponsor ID
- 24-007609
- Conditions
- Sickle Cell Disease
- Keywords
- Music Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 30 Oct 2025 (actual)
- 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.
This research aims to see if songwriting can help reduce anxiety in adolescents with Sickle Cell Disease. The purpose of the study is to discover if participants find songwriting and playing their songs to be practical and acceptable, and helpful for managing anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Music Therapy | Experimental | Behavioral: Songwriting intervention (active music therapy)Songwriting intervention |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescents aged 11-18 years of age at the time of enrollment and able to provide assent
- Diagnosed with any type of sickle cell disease
- Currently receiving care at pediatric center
- Able to read and write in English
Key exclusion criteria (2 listed)
- Care transitioned to adult facility
- Visual, hearing, or cognitive impairment which may impede the ability to complete the songwriting intervention or data collection measures
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 |
|---|---|---|
| Songwriting intervention (active music therapy)Participants will engage in a songwriting intervention with a music therapist. | Behavioural | Active Music Therapy |
Primary outcome
Change in State-Trait Anxiety Inventory score
Time frame: Baseline, 3 months
The State and Trait Anxiety Inventory measures anxiety. Participants respond to 20 questions about how they are currently feeling on a 4-point Likert scale of 1 (not at all) to 4 (very much so). A total score is calculated by summing the item responses and ranges from 20 to 80. Higher scores indicate higher anxiety (a worse outcome) and lower scores indicate less anxiety (a better outcome).
Change in Patient Health Questionnaire (PHQ-A) score Change in Patient Health Questionnaire for Adolescents (PHQ-A) score
Time frame: Baseline, 3 months
The Patient Health Questionnaire for Adolescents (PHQ-A) is a modified version of the PHQ-9 to be used with adolescents. Participants respond to 9 questions scored on a 4-point Likert scale of 0 (Not at all) to 3 (Nearly every day). A total score is calculated by summing the item responses and ranges from 0 to 27; higher scores are associated with higher levels of or more severe depression.
Change in Connor Davidson Resilience Scale (CD-RISC 10) score
Time frame: Baseline, 3 months
The Connor-Davidson Resilience scale (CD-RISC) measures resilience. Participants respond to 10 questions scored on a 5-point Likert scale of 0 (Not true at all) to 4 (True nearly all the time). A total score is calculated by summing the item responses and ranges from 0 to 40; with higher scores reflecting greater resilience.
Change in Difficulties in Emotion Regulation Scale (DERS-SF) score
Time frame: Baseline, 3 months
The Difficulties in Emotion Regulation Scale Short Form (DERS-SF) measures difficulties in emotion regulation in adults and adolescents. It consists of six subscales: Nonacceptance, Goals, Impulse, Awareness, Strategies, and Clarity, each with three items. Participants respond to 18 questions scored on a 5-point Likert scale of 1 (Almost never) to 5 (Almost always). A total score is calculating by summing the item responses and ranges from 18 to 90; higher scores indicate greater difficulty with emotion regulation skills.
Change in PROMIS Pediatric Pain Behavior (SF-8a) score
Time frame: Baseline, 3 months
The PROMIS Pediatric Pain Behavior (SF-8a) short form measures behaviors that typically indicate to others that an individual is experiencing pain. Participants respond to 8 questions scored on a 6-point Likert scale of 1 (Had no pain) to 6 (Almost always). A total score is calculated by summing the item responses and ranges from 8 to 48, with higher scores indicating a more pain related behavior.
Change in PROMIS Pediatric Pain Quality - Affective (SF-8a) score
Time frame: Baseline, 3 months
The PROMIS Pediatric Pain Quality- Affective (SF-8a) short form assesses the emotional distress that accompanies pain. Participants respond to 8 yes or no questions (0 = no, 1 = yes). A total score is calculated by summing the item responses and ranges from 0 to 8, with higher scores indicating a greater impact of pain on emotional distress.
Change in PROMIS Pediatric Pain Quality - Sensory (SF-8a) score
Time frame: Baseline, 3 months
The PROMIS Pediatric Pain Quality - Sensory (SF-8a) short form assesses the sensory experiences of pain. Participants respond to 8 questions scored on a 5-point Likert scale of 1 (Not at all) to 5 (Very much). A total score is calculated by summing the item responses and ranges from 8 to 40, with higher scores indicating participants experiencing increased sensory responses to pain.
Change in PROMIS Pediatric Physical Stress Experiences (SF-8a) score
Time frame: Baseline, 3 months
The PROMIS Pediatric Physical Stress Experiences (SF-8a) short form assess the physically experienced sensations associated with pain. Participants respond to 8 questions scored on a 5-point Likert scale of 1 (Never) to 5 (Always). A total score is calculated by summing the item responses and ranges from 8 to 40, with higher scores indicating a greater impact of pain on physical stress experienced.
Change in PROMIS Pediatric Psychological Stress Experience (SF) score
Time frame: Baseline, 3 months
The PROMIS Pediatric Psychological Stress Experience (SF) short form assesses the thoughts and feelings associated with pain. It measures facets of stress, including feeling overwhelmed, lack of perceived control, and cognitive-perceptual disruption, using a 7-day recall period. Participants respond to 8 questions scored on a 5-point Likert scale of 1 (Never) to 5 (Always). A total score is calculated by summing the item responses and ranges from 8 to 40, with higher scores indicating a greater impact of pain on psychological stress.
Change in PROMIS Pediatric Physical Activity (SF) score
Time frame: Baseline, 3 months
The PROMIS Pediatric Physical Activity (SF) measure self-reported capability of physical activities. Participants respond to 8 questions scored on a 5-point Likert scale of 0 (No days) to 5 (6-7 days). A total score is calculated by summing item responses and ranges from 0 to 40, with higher scores indicating a greater deal of physical activity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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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.
C. Robert Bennett contact
C. Robert Bennett, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Songwriting intervention (active music therapy) in people with Sickle Cell Disease, run by Mayo Clinic 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 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pam Peterson (507-422-5523, Peterson.Pamela@Mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State-Trait Anxiety Inventory score (time frame: Baseline, 3 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2026.