Interoceptive Awareness and Function in Adolescents With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Profile GenPop v.3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Study Group
Participants who are diagnosed with a form of chronic pain and are referred for occupational therapy treatment services.
干预措施: Occupational Therapy (Other)
结局指标
主要结局
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Profile GenPop v.3
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 3 Month Follow-up Survey(Survey will be sent out to study group participants 3 months after their last occupational therapy treatment visit.)