Recruiting

Occupational Therapy

Sponsor:

Connecticut Children's Medical Center

Code:

NCT07325110

Conditions

Chronic Pain

Chronic Pain Syndrome

Pain, Chronic

Eligibility Criteria

Sex: All

Age: 11 - 21

Healthy Volunteers: Not accepted

Interventions

Occupational Therapy

Study Details

Brief summary:

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.

Conditions

Chronic Pain

Chronic Pain Syndrome

Pain, Chronic

Study ID

NCT07325110

Start date

Feb 25, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 21

Healthy Volunteers: Not accepted

Study Group:

Inclusion Criteria:

1. Adolescents seen as new patients in the pain clinic at Connecticut Children's
2. Referred to occupational therapy services.
3. Adolescents diagnosed with a form of chronic pain.
4. Between the ages of 11 and 21 years at time of enrollment.
5. If over 18, the ability to understand and willingness to sign the informed consent document or the ability to use the short form process.
6. If under 18, the parent/legal guardian, has the ability to understand and willingness to sign the informed consent document or the ability to use the short form process.
7. Adolescents between the ages of 11 and less than 18 years with the ability to understand and willingness to sign assent.
8. Adolescents who agree to therapeutic yoga as a planned part of their occupational therapy treatment plan.

Exclusion Criteria:

1. Adolescents not receiving yoga as an element of their occupational therapy treatment plan.
2. Adolescents with a cognitive impairment that would impede their ability to participate.
3. 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.
4. Adolescents unwilling to complete surveys to participate in this research study.
5. Adolescents who are currently actively practicing yoga
6. Adolescents who are currently receiving occupational therapy at another location.

Study Design

Enrollment

49 participants

Anticipated

Interventions and Outcome Measures

Arms

Study Group

Participants who are diagnosed with a form of chronic pain and are referred for occupational therapy treatment services.

Interventions

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.

Primary outcome measure

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Profile GenPop v.3 [ 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 [ 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 [ 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 [ Time Frame: Assessment administered at the first therapy treatment visit and last treatment visit within a 4 month time frame. ]

Central Contacts and Locations

Central contacts

Allison Fell, BS

8608377331IAandFunctionStudy@connecticutchildrens.org

Samantha DeFrancesco, MOT

8608377331IAandFunctionStudy@connecticutchildrens.org

Locations

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

More Information

Sponsor

Connecticut Children's Medical Center

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

  • chronic pain
  • adolescents
  • interoceptive awareness
  • function
  • occupational therapy
  • yoga

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Connecticut Children's Medical Center on 2026-04-27.