Flexible Attention Sensory Training for Youth With Chronic Pain
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ClinicalTrials.gov Identifier: NCT06051305 |
Recruitment Status :
Recruiting
First Posted : September 22, 2023
Last Update Posted : November 18, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Persistent Pain | Behavioral: Sensory Training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Flexible Attention Sensory Training for Youth With Chronic Pain: A Feasibility and Acceptability Study |
Actual Study Start Date : | October 16, 2023 |
Estimated Primary Completion Date : | March 1, 2025 |
Estimated Study Completion Date : | March 1, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Sensory Training
Daily protocol - gamified sensory training
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Behavioral: Sensory Training
Participants will use gamified sensory training technology once daily for 8 weeks. This will involve participants completing a 15 minute sensory training session using the provided technology. The tool used in this study has two components. The first is a game that can be downloaded onto any smartphone device. The second component is two tactile devices that can be attached to the body. |
- Acceptability of the Intervention- Net Promoter Score [ Time Frame: Discharge (at 8 weeks) ]Acceptability will be evaluated by examining mean promoter score (measured on 10-point Likert scale) post intervention. Range 0-10 (higher scores indicate more acceptability). Questionnaire will be administered to youth with chronic pain.
- Acceptability of the Intervention- Qualitative Interview [ Time Frame: Discharge (at 8 weeks) ]Acceptability will also be assessed qualitatively at the end of treatment through interview questions related to acceptability, ease of use, comprehensibility, and suggestions for improvement. Survey responses will be reported categorically. Qualitative responses will be described and summarized.
- Acceptability of the Intervention- Theoretical framework of acceptability (TFA) Questionnaire [ Time Frame: Discharge (at 8 weeks) ]Acceptability will also be assessed quantitatively at the end of treatment through a brief survey related to acceptability, ease of use, comprehensibility, and suggestions for improvement. Survey responses will be reported categorically. Responses are measured using a five-point Likert scale from 'Strongly disagree' to 'Strongly agree' with higher scores indicating greater acceptability.
- Feasibility of the Intervention- Usage Metrics [ Time Frame: Baseline through discharge (at 8 weeks) ]Engagement will be assessed via collected use metrics (e.g. how long the app was played each day).
- Brief Pain Inventory Short Form (BPI) [ Time Frame: Baseline through discharge (at 8 weeks) weekly and follow up (1-month) ]The Brief Pain Inventory evaluates the severity of a patient's pain and the impact of this pain on the patient's daily functioning. Measured on a 10-point Likert scale (range 0-10), higher scores indicate greater pain interference. Questionnaire will be administered to youth with chronic pain.
- Pediatric PainSCAN [ Time Frame: Baseline, discharge (at 8 weeks), and follow up (1-month) ]Screening tool for Nerve Pain and Complex Regional Pain Syndrome (CRPS) for children and teens. PainSCAN is a tool used for screening of type of chronic pain condition, and results will be used to gauge pain type and severity.
- Bodily Threat Monitoring Scale (BTMS) [ Time Frame: Baseline, discharge (at 8 weeks), and follow up (1-month) ]Bodily threat monitoring will be assessed via a 19-item self-report measure. Higher scores indicate greater propensity to monitor the body for threatening signs and symptoms.
- Patient Global Impression of Change (PGIC) Scale [ Time Frame: Baseline, discharge (at 8 weeks), and follow up (1-month) ]Single question asking participants to rate how their condition has changed since a specified point in time, with lower scores indicating greater degree of improvement.
- Pain Vigilance and Awareness Questionnaire (PVAQ) [ Time Frame: Baseline, discharge (at 8 weeks), and follow up (1-month) ]The PVAQ is a 16-item measure of attention to pain. Participants are asked to consider behavior over the past 2-weeks and indicate how frequently (0, never; 5, always) an item was true. Higher scores indicate higher pain vigilance and awareness.
- Child Pain Acceptance Questionnaire (CPAQ) [ Time Frame: Baseline, discharge (at 8 weeks), and follow up (1-month) ]Child report on the Chronic Pain Acceptance Questionnaire for Adolescents-short form will be used to assess pain acceptance in the child. The CPAQ is an 8-item measure consisting of two subscales: Activity Engagement (4 items) and Pain Willingness (4 items). Items are rated on a 5-point Likert scale ranging from 0 (Never True) to 4 (Always True) and yield a total score for each subscale ranging from 0-16. Higher scores indicate greater Activity Engagement and greater Pain Willingness.
- Multidimensional Assessment of Interoceptive Awareness Youth (MAIA-Y) [ Time Frame: Baseline, discharge (at 8 weeks), and follow up (1-month) ]The MAIA-Y is an 8-scale state-trait questionnaire with 32 items. It measures multiple dimensions of interoception. Scoring is at the individual scale-level, with higher scores equated with more bodily sensation awareness. The individual score is also given as a percentile relative to normative sample, with extreme percentiles (>10, 90<) of clinical significance. Three scales from this measures are being administered: Attention Regulation, Self-Regulation, Trusting.
- Adverse events [ Time Frame: Baseline through 8 weeks ]
- Treatment Expectancy and Credibility (TEC) [ Time Frame: Baseline, discharge (at 8 weeks) ]Participants (child) and parent expectations for treatment will be measured by the Treatment Expectancy and Creditability. The TEC is comprised of 6 items rated on a 0 to 10 Likert-scale assessing expectations related to the effectiveness of the current treatment. The TEC is completed by the patient at the end of the first treatment session and at the end of treatment (8 weeks). Higher scores indicate greater expectations for treatment effectiveness.
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Ages Eligible for Study: | 10 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of musculoskeletal pain including chronic regional pain syndrome
- English speaking
Exclusion Criteria:
- Diagnosis of neurological conditions such as seizures, cerebral palsy, developmental delay
- Severe affect disorders (e.g. severe depression/anxiety) from medical record review
- Chronic skin disease or topical allergies that would be worsened by the use of sensor tape
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051305
Contact: Laura Simons, PhD | (650) 723-6412 | lesimons@stanford.edu | |
Contact: Nicole Jehl, BS | (650) 725-8111 | njehl@stanford.edu |
United States, California | |
Stanford Pediatric Pain Clinic | Recruiting |
Menlo Park, California, United States, 94025 | |
Contact: Nicole Jehl, B.S. 650-725-8111 njehl@stanford.edu |
Principal Investigator: | Laura Simons, PhD | Stanford University |
Responsible Party: | Laura E Simons, Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University |
ClinicalTrials.gov Identifier: | NCT06051305 |
Other Study ID Numbers: |
67616 |
First Posted: | September 22, 2023 Key Record Dates |
Last Update Posted: | November 18, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Chronic Pain Pain Neurologic Manifestations |