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Completed

NCT Number: NCT06051305

Flexible Attention Sensory Training for Youth with Chronic Pain

The purpose of this study is to determine the feasibility and acceptability of gamified sensory rehabilitation training technology for children with chronic musculoskeletal pain.

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Key information

Conditions

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Pediatric Pain Clinic

Menlo Park, California, 94025, United States

About this study

The TrainPain devices allows patients with chronic pain to perform sensory rehabilitation training at home, in a gamified format. The system uses a temporary tactile discrimination task, which directly engages inhibitory functions of the somatosensory cortex. In this way, the game trains the brain's sensory system to be more precise. The technology's dual-probe system allows sensory stimuli to be delivered to multiple body locations, which trains patients to flexibly shift their attention towards and away from pain according to dynamic game-directed goals. The sensory training reduces hypervigilance towards painful body regions and enables flexible attention shifting to engage with daily goals. Last, the TrainPain system captures and quantifies performance over time, providing a breadth of intricate and precise data, thus allowing the research team to assess outcomes and mechanisms of training effects. In preliminary studies with adults, TrainPain is shown to be highly engaging, and effective at reducing pain in adults with widespread musculoskeletal (MSK) pain. The current pilot study intends to establish, for the first time, the feasibility and acceptability of using the TrainPain system among youth with chronic MSK pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sensory training

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Revised Life Orientation Test (LOT-R)

    Time frame: Baseline, discharge (at 8 weeks), and follow up (1-month)

    The Revised Life Orientation Test will be used to assess self-reported optimism in the child. The LOT-R is a 10-item measure yielding a total score ranging from 0-20 (only 5 items are utilized in the final score calculation). Higher scores indicate greater optimism.

  8. Childrens Hope Scale (CHS)

    Time frame: Baseline, discharge (at 8 weeks), and follow up (1-month)

    The Childrens Hope Scale will be used to assess self-reported hope in the child. The CHS is a 6-item measure yielding a total score ranging from 0-36, with higher scores indicating greater hope/

  9. Pain Catastrophizing Scale (PCS-C)

    Time frame: Baseline, discharge (at 8 weeks), and follow up (1-month)

    The Pain Catastrophizing Scale -Child Version (PCS-C, Crombez et al., 2003) assesses negative cognitions associated with pain. The PCS-C is comprised of 13-items rated on a 5-point Likert scale (0= "not at all true" to 4 "very true"). A total score (0-52) is obtained by summing all items. Higher scores indicate higher levels of catastrophic thinking.

  10. Weekly Diary

    Time frame: Treatment (weekly for 8 weeks)

    We are administering an additional 13-item weekly diary, developed by our group, which measure self-reported fear, avoidance, functioning, activity engagement, pain reactivity, and attention.

  11. Parent Psychological Flexibility Questionnaire (PPF-P)

    Time frame: Baseline, discharge (at 8 weeks), and follow up (1-month)

    The Parent Psychological Flexibility Questionnaire (PPFQ-10, Timmers et al., 2019) is a 10-item parent self-report questionnaire assessing a parent's ability to accept their own distress and respond adaptively and flexibly to their child's pain. Items are rated on a 5-point Likert scale (0= " never true" to 4 = "always true") and are summed to create a total score, ranging from 0 - 40. Higher scores indicate greater parent psychological flexibility.

  12. Pain Catastrophizing Scale (PCS-P)

    Time frame: Baseline, discharge (at 8 weeks), and follow up (1-month)

    Pain Catastrophizing Scale-Parent Version (PCS-P, Goubert et al., 2006) assesses parents' negative cognitions associated with their child's pain. It is comprised of 13 items rated on a 5-point Likert scale (0 = "not true at all" to 4 = "very true"). A total score (0-52) is derived by summing items, with higher scores indicating higher levels of catastrophic thinking.

Other outcomes

  1. Adverse events

    Time frame: Baseline through 8 weeks

  2. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Flexible Attention Sensory Training for Youth with Chronic Pain: a Feasibility and Acceptability Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2023
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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