Chronic PainNCT07325110
Interoceptive Awareness and Function in Adolescents With Chronic Pain
An observational study of Chronic Pain and Chronic Pain Syndrome, run by Connecticut Children's Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 21 years
- Conditions the study is for
- Chronic Pain, Chronic Pain Syndrome, Pain, Chronic
- What is being tested?
- Occupational Therapy
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study 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.
Who may be able to join
- 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.
- If over 18, the ability to understand and willingness to sign the informed consent document or the ability to use the short form process.
- 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.
- Adolescents between the ages of 11 and less than 18 years with the ability to understand and willingness to sign assent.
- Adolescents who agree to therapeutic yoga as a planned part of their occupational therapy treatment plan.
Who cannot join
- 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.
- Adolescents who are currently actively practicing yoga
- Adolescents who are currently receiving occupational therapy at another location.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
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.
Read the detailed description
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
- Consent/assent will take place at the pain team visit within a private treatment room by one of the study team members. The participant and family will be given a detailed description of the purpose of the study and expectations for participants. The participant and family will have the opportunity to read the consent forms and ask any questions the participant and/or family may have about the research.
- If the participant agrees to enroll in the study, the participant will be asked to complete the electronic signature in Research Electronic Data Capture (REDCap) to complete the consenting process. A paper version will be available if needed.
- If in the scenario where a legal guardian is not present and required for consent, remote consenting will be offered to fulfill consenting requirements. A copy will be provided upon completion.
- All patients that are seen by the pain team and referred to the occupational therapy department at Connecticut Children's and consent for this study will begin therapy services within one month of being seen in clinic.
- During the first visit, the PROMIS and MAIA pre-test will be provided to the participant for completion within REDCap. A paper version will be available if needed and then inputted into REDCap by investigator.
- Over the twelve sessions, participants will be educated on and complete components of breathwork, mindfulness, and poses. These will be individualized for each participant, based on the participant's abilities and needs, from a list that has been developed along with a general outline of the progression of sessions.
- At the end of each session, a home program will be provided based off of concepts learned in treatment with expectation of implementation 3x per week.
- At the start of each visit, attendance will be recorded into REDCap and the participant will report the number of home program sessions completed since last visit and will be recorded in REDCap.
- During the last visit, the PROMIS and MAIA post-test will be provided to the participant for completion within REDCap. A paper version will be available if needed and then inputted into REDCap by investigator.
- A 3 month follow-up survey will be sent via email to all participants in the research group.
Data Collection and Management:
Allison Fell OTR/L and Samantha DeFrancesco OTR/L will oversee data management.
- Data collection forms: All data points and outcome measures will be completed and entered into a REDCap database to secure data and facilitate data analysis.
- Data collection software: The Research Operations and Development team assisted with the development of this REDCap project. The data will be collected by investigators, and it will be stored only in REDCap. The database will only be accessible to those individuals included in this study.
- Patient demographic data will be entered into REDCap- this would include the Medical Record Number (MRN), Date of birth, Sex/Gender, Race/ethnicity, Diagnosis, Insurance type, Email, and Phone number to allow for improved ease and accuracy of data collection. All other clinical data will be stored in REDCap. The data will be collected by investigators, and it will be entered into REDCap by Allison Fell OTR/L and Samantha DeFrancesco OTR/L to ensure data accuracy.
- Once data have been reviewed as stated above, medical record numbers will be removed from the main dataset. A separate file will be kept to link patient names and identification and medical record numbers. This will be used to keep a list of patients in case charts need to be re-visited to collect additional data.
- Record retention and confidentiality will be dictated by the current procedures at Connecticut Children's. All information will be stored in a password protected database and on a password protected computer. No access to information is possible from an outside source.
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.
- Conditions
- Chronic Pain, Chronic Pain Syndrome, Pain, Chronic
- Being tested
- Occupational Therapy
- Keywords
- chronic pain, adolescents, interoceptive awareness, function, occupational therapy, yoga
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Participants who are diagnosed with a form of chronic pain and are referred for occupational therapy treatment services. Receives: Other: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Survey will be sent out to study group participants 3 months after their last occupational therapy treatment visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start25 Feb 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Fell, BS, Principal investigator, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325110
- Sponsor's protocol ID
- 25-077
- Status last verified
- Apr 2026
- First submitted
- 11 Nov 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chambers CT, Dol J, Tutelman PR, Langley CL, Parker JA, Cormier BT, Macfarlane GJ, Jones GT, Chapman D, Proudfoot N, Grant A, Marianayagam J. The prevalence of chronic pain in children and adolescents: a systematic review update and meta-analysis. Pain. 2024 Oct 1;165(10):2215-2234. doi: 10.1097/j.pain.0000000000003267. Epub 2024 May 15.
PubMed 38743558Craig AD. How do you feel--now? The anterior insula and human awareness. Nat Rev Neurosci. 2009 Jan;10(1):59-70. doi: 10.1038/nrn2555.
PubMed 19096369Eccleston C, Malleson P. Managing chronic pain in children and adolescents. We need to address the embarrassing lack of data for this common problem. BMJ. 2003 Jun 28;326(7404):1408-9. doi: 10.1136/bmj.326.7404.1408. No abstract available.
PubMed 12829527Evans S, Moieni M, Sternlieb B, Tsao JC, Zeltzer LK. Yoga for youth in pain: the UCLA pediatric pain program model. Holist Nurs Pract. 2012 Sep-Oct;26(5):262-71. doi: 10.1097/HNP.0b013e318263f2ed.
PubMed 22864296Gnall KE, Sinnott SM, Laumann LE, Park CL, David A, Emrich M. Changes in Interoception in Mind-body Therapies for Chronic Pain: A Systematic Review and Meta-Analysis. Int J Behav Med. 2024 Dec;31(6):833-847. doi: 10.1007/s12529-023-10249-z. Epub 2024 Jan 2.
PubMed 38169051Hechler T. Altered interoception and its role for the co-occurrence of chronic primary pain and mental health problems in children. Pain. 2021 Mar 1;162(3):665-671. doi: 10.1097/j.pain.0000000000002099. No abstract available.
PubMed 33021565Horsburgh A, Summers SJ, Lewis A, Keegan RJ, Flood A. The Relationship Between Pain and Interoception: A Systematic Review and Meta-Analysis. J Pain. 2024 Jul;25(7):104476. doi: 10.1016/j.jpain.2024.01.341. Epub 2024 Jan 18.
PubMed 38244898Kempert H. The Use of Yoga as a Group Intervention for Pediatric Chronic Pain Rehabilitation: Exploring Qualitative and Quantitative Outcomes. Int J Yoga. 2020 Jan-Apr;13(1):55-61. doi: 10.4103/ijoy.IJOY_13_19.
PubMed 32030022Khalsa SS, Adolphs R, Cameron OG, Critchley HD, Davenport PW, Feinstein JS, Feusner JD, Garfinkel SN, Lane RD, Mehling WE, Meuret AE, Nemeroff CB, Oppenheimer S, Petzschner FH, Pollatos O, Rhudy JL, Schramm LP, Simmons WK, Stein MB, Stephan KE, Van den Bergh O, Van Diest I, von Leupoldt A, Paulus MP; Interoception Summit 2016 participants. Interoception and Mental Health: A Roadmap. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Jun;3(6):501-513. doi: 10.1016/j.bpsc.2017.12.004. Epub 2017 Dec 28.
PubMed 29884281Khalsa SB, Butzer B. Yoga in school settings: a research review. Ann N Y Acad Sci. 2016 Jun;1373(1):45-55. doi: 10.1111/nyas.13025. Epub 2016 Feb 25.
PubMed 26919395Koechlin H, Donado C, Locher C, Kossowsky J, Lionetti F, Pluess M. Sensory processing sensitivity in adolescents reporting chronic pain: an exploratory study. Pain Rep. 2023 Jan 6;8(1):e1053. doi: 10.1097/PR9.0000000000001053. eCollection 2023 Jan.
PubMed 36699990Lucas JW, Sohi I. Chronic Pain and High-impact Chronic Pain in U.S. Adults, 2023. NCHS Data Brief. 2024 Oct;(518):CS355235. doi: 10.15620/cdc/169630.
PubMed 39751180Mehling W. Differentiating attention styles and regulatory aspects of self-reported interoceptive sensibility. Philos Trans R Soc Lond B Biol Sci. 2016 Nov 19;371(1708):20160013. doi: 10.1098/rstb.2016.0013. Epub 2016 Oct 10.
PubMed 28080970Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.
PubMed 30513087Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939.
PubMed 32694387
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interoceptive Awareness and Function in Adolescents With Chronic Pain
- ClinicalTrials.gov ID
- NCT07325110
- Acronym / sponsor ID
- 25-077
- Conditions
- Chronic Pain, Chronic Pain Syndrome, Pain, Chronic
- Keywords
- chronic pain, adolescents, interoceptive awareness, function, occupational therapy, yoga
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Consent/assent will take place at the pain team visit within a private treatment room by one of the study team members. The participant and family will be given a detailed description of the purpose of the study and expectations for participants. The participant and family will have the opportunity to read the consent forms and ask any questions the participant and/or family may have about the research.
- If the participant agrees to enroll in the study, the participant will be asked to complete the electronic signature in Research Electronic Data Capture (REDCap) to complete the consenting process. A paper version will be available if needed.
- If in the scenario where a legal guardian is not present and required for consent, remote consenting will be offered to fulfill consenting requirements. A copy will be provided upon completion.
- All patients that are seen by the pain team and referred to the occupational therapy department at Connecticut Children's and consent for this study will begin therapy services within one month of being seen in clinic.
- During the first visit, the PROMIS and MAIA pre-test will be provided to the participant for completion within REDCap. A paper version will be available if needed and then inputted into REDCap by investigator.
- Over the twelve sessions, participants will be educated on and complete components of breathwork, mindfulness, and poses. These will be individualized for each participant, based on the participant's abilities and needs, from a list that has been developed along with a general outline of the progression of sessions.
- At the end of each session, a home program will be provided based off of concepts learned in treatment with expectation of implementation 3x per week.
- At the start of each visit, attendance will be recorded into REDCap and the participant will report the number of home program sessions completed since last visit and will be recorded in REDCap.
- During the last visit, the PROMIS and MAIA post-test will be provided to the participant for completion within REDCap. A paper version will be available if needed and then inputted into REDCap by investigator.
- A 3 month follow-up survey will be sent via email to all participants in the research group.
Data Collection and Management:
Allison Fell OTR/L and Samantha DeFrancesco OTR/L will oversee data management.
- Data collection forms: All data points and outcome measures will be completed and entered into a REDCap database to secure data and facilitate data analysis.
- Data collection software: The Research Operations and Development team assisted with the development of this REDCap project. The data will be collected by investigators, and it will be stored only in REDCap. The database will only be accessible to those individuals included in this study.
- Patient demographic data will be entered into REDCap- this would include the Medical Record Number (MRN), Date of birth, Sex/Gender, Race/ethnicity, Diagnosis, Insurance type, Email, and Phone number to allow for improved ease and accuracy of data collection. All other clinical data will be stored in REDCap. The data will be collected by investigators, and it will be entered into REDCap by Allison Fell OTR/L and Samantha DeFrancesco OTR/L to ensure data accuracy.
- Once data have been reviewed as stated above, medical record numbers will be removed from the main dataset. A separate file will be kept to link patient names and identification and medical record numbers. This will be used to keep a list of patients in case charts need to be re-visited to collect additional data.
- Record retention and confidentiality will be dictated by the current procedures at Connecticut Children's. All information will be stored in a password protected database and on a password protected computer. No access to information is possible from an outside source.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Occupational TherapyParticipants who are diagnosed with a form of chronic pain and are referred for occupational therapy treatment services. |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study 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.
Key inclusion criteria (8 listed)
- 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.
- If over 18, the ability to understand and willingness to sign the informed consent document or the ability to use the short form process.
Key exclusion criteria (6 listed)
- 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.
- Adolescents who are currently actively practicing yoga
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational TherapyParticipants 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. | Other | Study Group |
Primary outcome
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.
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).
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.
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).
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.
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.
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.
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.
1 secondary outcome
3 Month Follow-up Survey
Time frame: Survey will be sent out to study group participants 3 months after their last occupational therapy treatment visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Background: PubMed 38743558Chambers CT, Dol J, Tutelman PR, Langley CL, Parker JA, Cormier BT, Macfarlane GJ, Jones GT, Chapman D, Proudfoot N, Grant A, Marianayagam J. The prevalence of chronic pain in children and adolescents: a systematic review update and meta-analysis. Pain. 2024 Oct 1;165(10):2215-2234. doi: 10.1097/j.pain.0000000000003267. Epub 2024 May 15.
- Background: PubMed 19096369Craig AD. How do you feel--now? The anterior insula and human awareness. Nat Rev Neurosci. 2009 Jan;10(1):59-70. doi: 10.1038/nrn2555.
- Background: PubMed 12829527Eccleston C, Malleson P. Managing chronic pain in children and adolescents. We need to address the embarrassing lack of data for this common problem. BMJ. 2003 Jun 28;326(7404):1408-9. doi: 10.1136/bmj.326.7404.1408. No abstract available.
- Background: PubMed 22864296Evans S, Moieni M, Sternlieb B, Tsao JC, Zeltzer LK. Yoga for youth in pain: the UCLA pediatric pain program model. Holist Nurs Pract. 2012 Sep-Oct;26(5):262-71. doi: 10.1097/HNP.0b013e318263f2ed.
- Background: PubMed 38169051Gnall KE, Sinnott SM, Laumann LE, Park CL, David A, Emrich M. Changes in Interoception in Mind-body Therapies for Chronic Pain: A Systematic Review and Meta-Analysis. Int J Behav Med. 2024 Dec;31(6):833-847. doi: 10.1007/s12529-023-10249-z. Epub 2024 Jan 2.
- Background: PubMed 33021565Hechler T. Altered interoception and its role for the co-occurrence of chronic primary pain and mental health problems in children. Pain. 2021 Mar 1;162(3):665-671. doi: 10.1097/j.pain.0000000000002099. No abstract available.
- Background: PubMed 38244898Horsburgh A, Summers SJ, Lewis A, Keegan RJ, Flood A. The Relationship Between Pain and Interoception: A Systematic Review and Meta-Analysis. J Pain. 2024 Jul;25(7):104476. doi: 10.1016/j.jpain.2024.01.341. Epub 2024 Jan 18.
- Background: PubMed 32030022Kempert H. The Use of Yoga as a Group Intervention for Pediatric Chronic Pain Rehabilitation: Exploring Qualitative and Quantitative Outcomes. Int J Yoga. 2020 Jan-Apr;13(1):55-61. doi: 10.4103/ijoy.IJOY_13_19.
- Background: PubMed 29884281Khalsa SS, Adolphs R, Cameron OG, Critchley HD, Davenport PW, Feinstein JS, Feusner JD, Garfinkel SN, Lane RD, Mehling WE, Meuret AE, Nemeroff CB, Oppenheimer S, Petzschner FH, Pollatos O, Rhudy JL, Schramm LP, Simmons WK, Stein MB, Stephan KE, Van den Bergh O, Van Diest I, von Leupoldt A, Paulus MP; Interoception Summit 2016 participants. Interoception and Mental Health: A Roadmap. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Jun;3(6):501-513. doi: 10.1016/j.bpsc.2017.12.004. Epub 2017 Dec 28.
- Background: PubMed 26919395Khalsa SB, Butzer B. Yoga in school settings: a research review. Ann N Y Acad Sci. 2016 Jun;1373(1):45-55. doi: 10.1111/nyas.13025. Epub 2016 Feb 25.
- Background: PubMed 36699990Koechlin H, Donado C, Locher C, Kossowsky J, Lionetti F, Pluess M. Sensory processing sensitivity in adolescents reporting chronic pain: an exploratory study. Pain Rep. 2023 Jan 6;8(1):e1053. doi: 10.1097/PR9.0000000000001053. eCollection 2023 Jan.
- Background: PubMed 39751180Lucas JW, Sohi I. Chronic Pain and High-impact Chronic Pain in U.S. Adults, 2023. NCHS Data Brief. 2024 Oct;(518):CS355235. doi: 10.15620/cdc/169630.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison Fell, BS principal investigator
Connecticut Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Chronic Pain Syndrome, run by Connecticut Children's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison Fell, BS (8608377331, IAandFunctionStudy@connecticutchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07325110, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.