Flexible Attention Sensory Training for Youth With Chronic Pain
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sensory Training Daily protocol - gamified sensory training |
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.
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Outcome Measures
Primary Outcome Measures
- Acceptability of the Intervention- Net Promoter Score [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 [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 [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 [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 Outcome Measures
- Brief Pain Inventory Short Form (BPI) [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 [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) [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 [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) [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) [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) [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.
Other Outcome Measures
- Adverse events [Baseline through 8 weeks]
- Treatment Expectancy and Credibility (TEC) [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of musculoskeletal pain including chronic regional pain syndrome
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English speaking
Exclusion Criteria:
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Diagnosis of neurological conditions such as seizures, cerebral palsy, developmental delay
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Severe affect disorders (e.g. severe depression/anxiety) from medical record review
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Chronic skin disease or topical allergies that would be worsened by the use of sensor tape
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Stanford University
Investigators
- Principal Investigator: Laura Simons, PhD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
- Borkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. Journal of behavior therapy and experimental psychiatry, 3(4), 257-260.
- Castarlenas E, Jensen MP, von Baeyer CL, Miro J. Psychometric Properties of the Numerical Rating Scale to Assess Self-Reported Pain Intensity in Children and Adolescents: A Systematic Review. Clin J Pain. 2017 Apr;33(4):376-383. doi: 10.1097/AJP.0000000000000406.
- Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
- Ferguson, L., & Scheman, J. (2009). Patient global impression of change scores within the context of a chronic pain rehabilitation program. The Journal of Pain, 10(4), S73.
- Gauntlett-Gilbert J, Alamire B, Duggan GB. Pain Acceptance in Adolescents: Development of a Short Form of the CPAQ-A. J Pediatr Psychol. 2019 May 1;44(4):453-462. doi: 10.1093/jpepsy/jsy090.
- Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One. 2012;7(11):e48230. doi: 10.1371/journal.pone.0048230. Epub 2012 Nov 1.
- Mendoza T, Mayne T, Rublee D, Cleeland C. Reliability and validity of a modified Brief Pain Inventory short form in patients with osteoarthritis. Eur J Pain. 2006 May;10(4):353-61. doi: 10.1016/j.ejpain.2005.06.002. Epub 2005 Jul 26.
- Mesaroli G, Campbell F, Hundert A, Birnie KA, Sun N, Davidge KM, Lalloo C, Davies-Chalmers C, Harris L, Stinson J. Development of a Screening Tool for Pediatric Neuropathic Pain and Complex Regional Pain Syndrome: Pediatric PainSCAN. Clin J Pain. 2021 Oct 12;38(1):15-22. doi: 10.1097/AJP.0000000000000993.
- Roelofs J, Peters ML, McCracken L, Vlaeyen JWS. The pain vigilance and awareness questionnaire (PVAQ): further psychometric evaluation in fibromyalgia and other chronic pain syndromes. Pain. 2003 Feb;101(3):299-306. doi: 10.1016/S0304-3959(02)00338-X.
- Sekhon M, Cartwright M, Francis JJ. Development of a theory-informed questionnaire to assess the acceptability of healthcare interventions. BMC Health Serv Res. 2022 Mar 1;22(1):279. doi: 10.1186/s12913-022-07577-3.
- Vowles KE, McCracken LM, McLeod C, Eccleston C. The Chronic Pain Acceptance Questionnaire: confirmatory factor analysis and identification of patient subgroups. Pain. 2008 Nov 30;140(2):284-291. doi: 10.1016/j.pain.2008.08.012. Epub 2008 Sep 27.
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