Back to resultsFlexible Attention Sensory Training for Youth With Chronic Pain
Primary Purpose
Persistent Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sensory Training
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Pain
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sensory Training
Arm Description
Daily protocol - gamified sensory training
Outcomes
Primary Outcome Measures
Acceptability of the Intervention- Net Promoter Score
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
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
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
Engagement will be assessed via collected use metrics (e.g. how long the app was played each day).
Secondary Outcome Measures
Brief Pain Inventory Short Form (BPI)
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
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)
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
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)
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)
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)
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.
Full Information
NCT ID
NCT06051305
First Posted
August 16, 2023
Last Updated
September 20, 2023
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT06051305
Brief Title
Flexible Attention Sensory Training for Youth With Chronic Pain
Official Title
Flexible Attention Sensory Training for Youth With Chronic Pain: A Feasibility and Acceptability Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the feasibility and acceptability of gamified sensory rehabilitation training technology for children with chronic musculoskeletal pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sensory Training
Arm Type
Experimental
Arm Description
Daily protocol - gamified sensory training
Intervention Type
Behavioral
Intervention Name(s)
Sensory Training
Intervention Description
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 Outcome Measure Information:
Title
Acceptability of the Intervention- Net Promoter Score
Description
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.
Time Frame
Discharge (at 8 weeks)
Title
Acceptability of the Intervention- Qualitative Interview
Description
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.
Time Frame
Discharge (at 8 weeks)
Title
Acceptability of the Intervention- Theoretical framework of acceptability (TFA) Questionnaire
Description
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.
Time Frame
Discharge (at 8 weeks)
Title
Feasibility of the Intervention- Usage Metrics
Description
Engagement will be assessed via collected use metrics (e.g. how long the app was played each day).
Time Frame
Baseline through discharge (at 8 weeks)
Secondary Outcome Measure Information:
Title
Brief Pain Inventory Short Form (BPI)
Description
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.
Time Frame
Baseline through discharge (at 8 weeks) weekly and follow up (1-month)
Title
Pediatric PainSCAN
Description
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.
Time Frame
Baseline, discharge (at 8 weeks), and follow up (1-month)
Title
Bodily Threat Monitoring Scale (BTMS)
Description
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.
Time Frame
Baseline, discharge (at 8 weeks), and follow up (1-month)
Title
Patient Global Impression of Change (PGIC) Scale
Description
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.
Time Frame
Baseline, discharge (at 8 weeks), and follow up (1-month)
Title
Pain Vigilance and Awareness Questionnaire (PVAQ)
Description
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.
Time Frame
Baseline, discharge (at 8 weeks), and follow up (1-month)
Title
Child Pain Acceptance Questionnaire (CPAQ)
Description
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.
Time Frame
Baseline, discharge (at 8 weeks), and follow up (1-month)
Title
Multidimensional Assessment of Interoceptive Awareness Youth (MAIA-Y)
Description
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.
Time Frame
Baseline, discharge (at 8 weeks), and follow up (1-month)
Other Pre-specified Outcome Measures:
Title
Adverse events
Time Frame
Baseline through 8 weeks
Title
Treatment Expectancy and Credibility (TEC)
Description
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.
Time Frame
Baseline, discharge (at 8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Simons, PhD
Phone
(650) 723-6412
Email
lesimons@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Jehl, BS
Phone
(650) 725-8111
Email
njehl@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Simons, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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Results Reference
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Citation
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Flexible Attention Sensory Training for Youth With Chronic Pain
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