Interoceptive Awareness and Function in Adolescents With Chronic Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age11-21
SponsorConnecticut Children's Medical Center
About this trial
The main objectives of this study are to compare the levels of interoceptive awareness and self-reported function pre and post completion of an occupational therapy treatment plan. The target population are adolescents aged 11-21 years that are diagnosed with chronic pain and are seen through the Pain Team at Connecticut Children's. The primary aims are:
* To compare the reported levels of interoceptive awareness in adolescents with chronic pain before and after their occupational therapy treatment plan. * To compare the reported levels of function in adolescents with chronic pain before and after their occupational therapy treatment plan.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adolescents seen as new patients in the pain clinic at Connecticut Children's
Referred to occupational therapy services.
Adolescents diagnosed with a form of chronic pain.
Between the ages of 11 and 21 years at time of enrollment.
Disqualifiers
Adolescents not receiving yoga as an element of their occupational therapy treatment plan.
Adolescents with a cognitive impairment that would impede their ability to participate.
Adolescents with a neuromuscular diagnosis, such as Cerebral Palsy, Spinal Muscular Atrophy, and Muscular Dystrophies, that are not appropriate for yoga as an element of their treatment plan for this study.
Adolescents unwilling to complete surveys to participate in this research study.
Trial population
Participants for this study are patients seen within the Pain Team Clinic at Connecticut Children's. They are adolescents aged 11-21 years old that are diagnosed with a form of chronic pain and are referred for occupational therapy services.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Occupational Therapy
Other interventionParticipants will receive an occupational therapy treatment plan of care that includes yoga for 8-12 weekly visits. They will complete pre and post questionnaires to measure their interoceptive awareness and function.
Treatment groups
49 Participants
are divided into 1 treatment groupGroup A: Study Group1 intervention
Trial outcomes
Primary outcomes
1
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Profile GenPop v.3
For ages 8-17. The PROMIS is a system that measures how patients feel and function in terms of their physical, mental, and social health. It measures pain, fatigue, physical functioning, emotional distress, and social role participation. PROMIS uses a series of questions to assess how patients feel and what they are able to do. It is a total of 36 questions with a collection of 5- and 6-item short forms assessing anxiety, depressive symptoms, fatigue, pain interference, physical function-mobility, and peer relationships, as well as a single pain intensity item. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation (SD) of 10 because calibration testing was performed on a large sample of the general population. The T-score is provided with an error term. A higher PROMIS T-score represents more of the concept being measured. A PROMIS score includes a T-score and a standard error (SE).
Time frame
Assessment administered at the first therapy treatment visit and last treatment visit within a 4 month time frame.2
Patient-Reported Outcomes Measurement Information System (PROMIS)-43 Profile v2.1
For ages 18+. The PROMIS is a system that measures how patients feel and function in terms of their physical, mental, and social health. It measures pain, fatigue, physical functioning, emotional distress, and social role participation. PROMIS uses a series of questions to assess how patients feel and what they are able to do. It is a total of 43 questions with a collection of 6-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation (SD) of 10 because calibration testing was performed on a large sample of the general population. The T-score is provided with an error term. A higher PROMIS T-score represents more of the concept being measured. A PROMIS score includes a T-score and a standard error (SE).
Time frame
Assessment administered at the first therapy treatment visit and last treatment visit within a 4 month time frame.3
Multidimensional Assessment of Interoceptive Awareness- Version 2
For ages 18+. The Multidimensional Assessment of Interoceptive Awareness is a patient reported questionnaire with 37-items to measure multiple dimensions of interoception (body awareness) through an 8-subscale state-trait questionnaire. The areas this assessment measures are noticing, non-distracting, not worrying, attention regulation, emotional awareness, self-regulation, body listening, and trust. Scoring: Scores are between 0 and 5, where higher score equates to more awareness of bodily sensation. A percentile is also calculated, indicating how the responded scored in comparison to a normative sample. Interpretation using percentiles helps contextualize scores. For example, percentile below 50 indicate that the individual scored below what is typical. Extreme percentile scores (below 10 or above 90) are of particular clinical significance.
Time frame
Assessment administered at the first therapy treatment visit and last treatment visit within a 4 month time frame.4
Multidimensional Assessment of Interoceptive Awareness- Youth
For ages 7-17. The Multidimensional Assessment of Interoceptive Awareness is a patient reported questionnaire with 32-items to measure multiple dimensions of interoception (body awareness) through an 8-scale state-trait questionnaire. The areas this assessment measures are noticing, non-distracting, not worrying, attention regulation, emotional awareness, self-regulation, body listening, and trust. Scoring: Scores are between 0 and 5, where higher score equates to more awareness of bodily sensation. A percentile is also calculated, indicating how the responded scored in comparison to a normative sample. Interpretation using percentiles helps contextualize scores. For example, percentile below 50 indicate that the individual scored below what is typical. Extreme percentile scores (below 10 or above 90) are of particular clinical significance.
Time frame
Assessment administered at the first therapy treatment visit and last treatment visit within a 4 month time frame.Secondary outcomes
1
3 Month Follow-up Survey
4 question survey to assess participant continued use of strategies learned in therapy.
Time frame
Survey will be sent out to study group participants 3 months after their last occupational therapy treatment visit.Sponsors and contacts
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Source ClinicalTrials.gov