An observational study in Chronic Pain, Chronic Pain Syndrome and Pain, Chronic, sponsored by Connecticut Children's Medical Center. Recruiting at 1 site in United States. Open to participants aged 11 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Connecticut Children's Medical Center · Observational
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:
Background:
There has been an increasing number of adolescents with chronic pain who have been referred to pain team and to occupational therapy (OT) for intervention. The investigators on this study have been using the multifaceted intervention of yoga to treat this complex impairment. The main objectives of this study are to compare the level 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. Data will be collected pre and post occupational therapy treatment plan through use of the Multidimensional Assessment of Interoceptive Awareness (MAIA) to look at possible changes in interoception and the Patient-Reported Outcomes Measurement Information System (PROMIS) to look at possible changes in function. Interoception is the 8th sensory system or the sense of internal bodily signals and interoceptive awareness is the ability to be aware of and respond to these sensations. The areas of function on the PROMIS are Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Peer Relationships/Social Roles and Activities, and Pain Interference. These participants will also complete a 4 question 3 month follow up survey. The participants in the study are a convenience sample of patients referred to therapy services from Pain Team visit.
Study Procedures:
Study Participants
Data Collection and Management:
Allison Fell OTR/L and Samantha DeFrancesco OTR/L will oversee data management.
Patient confidentiality statement:
Strict measures will be required for respecting and maintaining patient confidentiality. Collection of a patient identifier including medical record numbers and the patients name is necessary to ensure comprehensive inclusion of eligible subjects and accurate linking of data from different data sets. The database used for the study will be password protected and stored in REDCap. Once the study investigators have collected all the data, the data set will be frozen for analysis. At this time, the study investigators will completely de-identify all subjects. Medical record numbers as well as the patient's names will be removed and patients will be referred to by study number only. De-identification will take place once the study investigators have collected all data. The study investigators expect that these measures will minimize any risk to confidentiality very effectively, and that any unavoidable residual risk will be balanced generously by the potential benefit to society of the knowledge that will be obtained through this research.
Sample Size Justification:
For participant change the investigators will need 34 OT completers to provide ≥80% power for 0.5 Standard Deviation (SD) improvement.
Feasibility, Accrual, and Expected Duration of Accrual:
Over 200 new patients were referred to pain team last year in 2024. The study investigators plan to recruit as many of these patients that meet criteria to achieve a medium effect sample size within a 12-month duration.
Study Limitations:
There are several limitations anticipated with this study. These limitations include a small sample size from a single institution, no control group, and potential bias with patient selection.
Use of Study Results:
The outcomes of this study will be used to assist in quality improvement within the department and guide future research questions. The investigators plan to publish results in a peer-reviewed publication and to present the findings at a conference.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's planned enrollment of 49 is below the median of 126 across 688 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →Connecticut Children's Medical Center is the lead sponsor of 58 studies on the registry; 14 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Study Group:
Inclusion Criteria:
Exclusion Criteria:
Participants who are diagnosed with a form of chronic pain and are referred for occupational therapy treatment services.
Other: Occupational Therapy
Participants 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.
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.
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.
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.
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.
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.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Connecticut Children's Medical Center