Clinical symptoms that are often found to be comorbid with pediatric chronic pain include anxiety, depression as well as increased stress, obesity, and decreased physical conditioning. Integrative therapies have been increasingly offered at children's hospitals as part of an integrated approach to treatment. Limited research exits on the efficacy of mind-body practices (e.g., yoga) utilized in conjunction with evidenced-based non-pharmacological treatments like cognitive behavioral therapy (CBT) to treat pediatric pain. Hence, this 7-week interventional pilot study was conducted to evaluate the impact of combining yoga and CBT for both pediatric patients with chronic pain and their caregivers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
CBT trains individuals to identify and reframe dysfunctional thoughts to help improve mood and behavior. CBT intervention also includes teaching relaxation and mindfulness strategies, as well as ways to help improve functioning through the use of behavioral goal setting.
Yoga consists of physical exercises, breathing techniques, and meditation designed to condition the physical body, calm the mind, and stabilize emotions.
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Assessment of the feasibility of conducting a 7-week group intervention combining yoga and cognitive behavioral therapy (CBT)
Likert-scale used to quantify satisfaction with the intervention; content clarity; concept-applicability to current life; impression of program design; scheduling considerations and other open-ended questions about their study preferences
Time frame: Feasibility Questionnaires given after the 7-week intervention
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Pain Interference
Consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
PROMIS Social Health - Peer Relationships
Quality of relationships with friends and other acquaintances.
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
PROMIS Emotional Distress - Depressive Symptoms
Negative mood (sadness, guilt), views of self (self- criticism,worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose).
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
PROMIS Pediatric Global Health 7+2
Overall evaluation of one's physical and mental health.
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Pain Stages of Change Questionnaire - Child Proxy
Validated 30-item self-report measure (ages 12-18) that will assess the readiness or receptiveness of adolescents and their parents to adopt a self-management approach to pain
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Pain Catastrophizing Scale - Child Proxy
A 13-item self-report scale (ages 8-17) with versions that will evaluate catastrophizing thinking in the adolescent subjects as well as parents (in relation to their child's pain)
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Adult's Responses to Children's Symptoms - Child Proxy
A 29-item validated measure (ages 8-18) that will assess the behavior of parents (caregivers) in response to their child's pain, as self-reported by the parent (or reported by the child)
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Visual Analog Pain Score
An established patient-reported measure that will quantify each adolescent subject's pain severity. With anchors at 0 (No pain) and 100 (Worst pain possible), these subjects will indicate the level of pain intensity on a 100 mm line
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Pain Stages of Change Questionnaire - Parent Proxy
A validated 30-item self-report measure (ages 12-18) that will assess the readiness or receptiveness of adolescents and their parents to adopt a self-management approach to pain
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Pain Catastrophizing Scale - Parent Proxy
A 13-item self-report scale (ages 8-17) with versions that will evaluate catastrophizing thinking in the adolescent subjects as well as parents (in relation to their child's pain)
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Adult's Responses to Children's Symptoms - Parent Proxy
A 29-item validated measure (ages 8-18) that will assess the behavior of parents (caregivers) in response to their child's pain, as self-reported by the parent (or reported by the child)
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Brief Symptoms Inventory - Parent Proxy
A 53-item self-report measure that will assesses psychological functioning in adults. The instrument has three global indices as well as nine symptom dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
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