Pediatric Chronic Pain
Conditions
Keywords
pediatric pain, cognitive behavioral therapy, yoga
Brief summary
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy
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.
OTHERYoga
Yoga consists of physical exercises, breathing techniques, and meditation designed to condition the physical body, calm the mind, and stabilize emotions.
Sponsors
Children's Hospital of Philadelphia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Established Children's Hospital of Philadelphia (CHOP) patients 14-18 years old, of any gender, race, or ethnicity * English speaking * Has received a diagnosis related to the primary symptom of chronic pain * For adolescents who are less than 18 y/o, parental or guardian permission (informed consent) and adolescent assent (patient) * Parents or legal guardians of adolescents enrolled, who speak English * Parents or legal guardians' permission (informed consent) of their own participation
Exclusion criteria
* Current medical status or cognitive functioning precludes completing assessment instruments (e.g., cognitive or intellectual disability such as diagnosis of autism spectrum disorder) * Physical limitation, handicap, or injury that would prevent participation or risk further injury or harm (e.g. physical assistance required from a device) * Non-English speaking * For adolescents who are less than 18 years of age, parental or guardian permission (informed consent) and/or adolescent (patient) assent declined * Patient, who in the opinion of the investigator, may be non-compliant or unable to complete the study procedures * Parents or legal guardians of adolescents enrolled, who do not speak English * Parents or legal guardians' permission (informed consent) for their own participation or if the adolescent is less than 18 years of age and assent has been declined * Parents or legal guardians, who in the opinion of the investigator, may be non-compliant or unable to complete the study procedures (If the dyad or triad includes a primary caregiver who has a developmental delay, intellectual disability, or communication challenge that prohibits completion of questionnaires or participation in study sessions)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the feasibility of conducting a 7-week group intervention combining yoga and cognitive behavioral therapy (CBT) | Feasibility Questionnaires given after the 7-week intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Social Health - Peer Relationships | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | Quality of relationships with friends and other acquaintances. |
| PROMIS Emotional Distress - Depressive Symptoms | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 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). |
| PROMIS Pediatric Global Health 7+2 | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | Overall evaluation of one's physical and mental health. |
| Pain Stages of Change Questionnaire - Child Proxy | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 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 |
| Pain Catastrophizing Scale - Child Proxy | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 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) |
| Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Pain Interference | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 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. |
| Visual Analog Pain Score | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 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 |
| Pain Stages of Change Questionnaire - Parent Proxy | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 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 |
| Pain Catastrophizing Scale - Parent Proxy | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 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) |
| Adult's Responses to Children's Symptoms - Parent Proxy | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 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) |
| Brief Symptoms Inventory - Parent Proxy | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 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 |
| Adult's Responses to Children's Symptoms - Child Proxy | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 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) |
Countries
United States
Outcome results
None listed