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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient and Caregiver Intervention | Experimental | Patient and Caregivers receive both cognitive behavioral intervention and yoga interventions each week, for 7 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Feasibility Questionnaires given after the 7-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23428497 | Background | Hainsworth KR, Salamon KS, Khan KA, Mascarenhas B, Davies WH, Weisman SJ. A pilot study of yoga for chronic headaches in youth: promise amidst challenges. Pain Manag Nurs. 2014 Jun;15(2):490-8. doi: 10.1016/j.pmn.2012.12.002. Epub 2013 Feb 19. | |
| 24796681 | Background | Eccleston C, Palermo TM, Williams AC, Lewandowski Holley A, Morley S, Fisher E, Law E. Psychological therapies for the management of chronic and recurrent pain in children and adolescents. Cochrane Database Syst Rev. 2014 May 5;(5):CD003968. doi: 10.1002/14651858.CD003968.pub4. |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D015013 | Yoga |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D026441 | Mind-Body Therapies |
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|
| Yoga | Other | Yoga consists of physical exercises, breathing techniques, and meditation designed to condition the physical body, calm the mind, and stabilize emotions. |
|
| PROMIS Social Health - Peer Relationships | Quality of relationships with friends and other acquaintances. | 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). | 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. | 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 | 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) | 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) | 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 | 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 | 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) | 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) | 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 | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention |
| 24804619 | Background | Khalsa MK, Greiner-Ferris JM, Hofmann SG, Khalsa SB. Yoga-enhanced cognitive behavioural therapy (Y-CBT) for anxiety management: a pilot study. Clin Psychol Psychother. 2015 Jul-Aug;22(4):364-71. doi: 10.1002/cpp.1902. Epub 2014 May 7. |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D026241 | Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |