Writing Relaxing Beats in Adolescents Who Have Sickle Cell Disease

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 Overview

• Status: Recruiting
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Behavioral: Songwriting intervention (active music therapy)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pam Peterson; Phone Number: 507-422-5523; Email: Peterson.Pamela@Mayo.edu
• Study Contact Backup: Name: C. Robert Bennett; Email: Bennett.Robert@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Division of Nursing
      • Contact: Pam Peterson; Phone Number: 507-422-5523

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Music Therapy; Songwriting intervention	Behavioral: Songwriting intervention (active music therapy); Participants will engage in a songwriting intervention with a music therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline, 3 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: C. Robert Bennett, PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: October 27, 2025
• First Submitted That Met QC Criteria: October 27, 2025
• First Posted (Actual): October 30, 2025

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Music Therapy
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Anemia, Sickle Cell
• Other Study ID Numbers: 24-007609

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No