Interoceptive Awareness and Function in Adolescents With Chronic Pain

NCT07325110 | Recruiting

• 1 other identifier: 25-077
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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.

  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.

  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

  Survey will be sent out to study group participants 3 months after their last occupational therapy treatment visit.

Study Arms (1)

Study Group

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

Other: Occupational Therapy

Interventions

Occupational Therapy OTHER

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

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

RECRUITING

Related Publications (16)

• 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.

  PMID: 38743558 BACKGROUND

• Craig 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.

  PMID: 19096369 BACKGROUND

• Eccleston 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.

  PMID: 12829527 BACKGROUND

• Evans 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.

  PMID: 22864296 BACKGROUND

• Gnall 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.

  PMID: 38169051 BACKGROUND

• Hechler 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.

  PMID: 33021565 BACKGROUND

• Horsburgh 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.

  PMID: 38244898 BACKGROUND

• Kempert 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.

  PMID: 32030022 BACKGROUND

• Khalsa 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.

  PMID: 29884281 BACKGROUND

• Khalsa 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.

  PMID: 26919395 BACKGROUND

• Koechlin 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.

  PMID: 36699990 BACKGROUND

• Lucas 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.

  PMID: 39751180 BACKGROUND

• Mehling 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.

  PMID: 28080970 BACKGROUND

• Mehling 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.

  PMID: 30513087 BACKGROUND

• Raja 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.

  PMID: 32694387 BACKGROUND

• Salaffi F, Sarzi-Puttini P, Atzeni F. How to measure chronic pain: New concepts. Best Pract Res Clin Rheumatol. 2015 Feb;29(1):164-86. doi: 10.1016/j.berh.2015.04.023. Epub 2015 Jun 19.

  PMID: 26267010 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Allison Fell, BS

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Fell, BS

CONTACT

8608377331; IAandFunctionStudy@connecticutchildrens.org

Samantha DeFrancesco, MOT

CONTACT

8608377331; IAandFunctionStudy@connecticutchildrens.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2025
• First Posted: January 8, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)