Interoceptive Awareness and Function in Adolescents With Chronic Pain

Connecticut Children's Medical Center

Status

Enrolling

Conditions

Chronic Pain Syndrome

Chronic Pain

Pain, Chronic

Treatments

Other: Occupational Therapy

Study type

Observational

Funder types

Other

Identifiers

NCT07325110

25-077

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 estimated patients

Sex

All

Ages

11 to 21 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Study Group:

Inclusion Criteria:

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.

Exclusion Criteria:

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.