Recruiting NCT07222475
Writing Relaxing Beats in Adolescents Who Have Sickle Cell Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Songwriting intervention (active music therapy).
- Who it may be relevant to
- Registry conditions: Sickle Cell Disease. Basic parameters: 11 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral Songwriting intervention (active music therapy)
Participants will engage in a songwriting intervention with a music therapist.
Primary outcome measures
- Change in State-Trait Anxiety Inventory score [Time frame: Baseline, 3 months]
- Change in Patient Health Questionnaire (PHQ-A) score Change in Patient Health Questionnaire for Adolescents (PHQ-A) score [Time frame: Baseline, 3 months]
- Change in Connor Davidson Resilience Scale (CD-RISC 10) score [Time frame: Baseline, 3 months]
- Change in Difficulties in Emotion Regulation Scale (DERS-SF) score [Time frame: Baseline, 3 months]
- Change in PROMIS Pediatric Pain Behavior (SF-8a) score [Time frame: Baseline, 3 months]
- Change in PROMIS Pediatric Pain Quality - Affective (SF-8a) score [Time frame: Baseline, 3 months]
- Change in PROMIS Pediatric Pain Quality - Sensory (SF-8a) score [Time frame: Baseline, 3 months]
- Change in PROMIS Pediatric Physical Stress Experiences (SF-8a) score [Time frame: Baseline, 3 months]
- Change in PROMIS Pediatric Psychological Stress Experience (SF) score [Time frame: Baseline, 3 months]
- Change in PROMIS Pediatric Physical Activity (SF) score [Time frame: Baseline, 3 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Care transitioned to adult facility
- Visual, hearing, or cognitive impairment which may impede the ability to complete the songwriting intervention or data collection measures
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic Division of Nursing — Rochester
Identifiers
NCT: NCT07222475 · 24-007609