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临床试验/NCT07222475
NCT07222475招募中不适用

Writing Relaxing Beats in Adolescents Who Have Sickle Cell Disease

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Mayo Clinic
入组人数
30
试验地点
1
主要终点
Change in State-Trait Anxiety Inventory score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
11 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Active Music Therapy

Experimental

Songwriting intervention

干预措施: Songwriting intervention (active music therapy) (Behavioral)

结局指标

主要结局

Change in State-Trait Anxiety Inventory score

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

C. Robert Bennett

Principal Investigator

Mayo Clinic

研究点 (1)

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