Writing Relaxing Beats in Adolescents Who Have Sickle Cell Disease

NCT07222475 | Recruiting

• 1 other identifier: 24-007609
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sickle Cell Disease

Keywords

Music Therapy

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

Active Music Therapy

EXPERIMENTAL

Songwriting intervention

Behavioral: Songwriting intervention (active music therapy)

Interventions

Songwriting intervention (active music therapy) BEHAVIORAL

Participants will engage in a songwriting intervention with a music therapist.

Active Music Therapy

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Care transitioned to adult facility
• Visual, hearing, or cognitive impairment which may impede the ability to complete the songwriting intervention or data collection measures

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Division of Nursing

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• C. Robert Bennett, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pam Peterson

CONTACT

507-422-5523; Peterson.Pamela@Mayo.edu

C. Robert Bennett

CONTACT

Bennett.Robert@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: October 30, 2025
• Study Start: February 5, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)