Flexible Attention Sensory Training for Youth with Chronic Pain

NCT06051305 | Completed

• 1 other identifier: 67616
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Pain

Outcome Measures

Primary Outcomes (4)

• 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.

  Discharge (at 8 weeks)

• 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.

  Discharge (at 8 weeks)

• 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.

  Discharge (at 8 weeks)

• Feasibility of the Intervention- Usage Metrics

  Engagement will be assessed via collected use metrics (e.g. how long the app was played each day).

  Baseline through discharge (at 8 weeks)

Secondary Outcomes (12)

• Brief Pain Inventory Short Form (BPI)

  Baseline through discharge (at 8 weeks) weekly and follow up (1-month)

• Bodily Threat Monitoring Scale (BTMS)

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

• Patient Global Impression of Change (PGIC) Scale

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

• Pain Vigilance and Awareness Questionnaire (PVAQ)

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

• Child Pain Acceptance Questionnaire (CPAQ)

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

Other Outcomes (2)

• Adverse events

  Baseline through 8 weeks

• Treatment Expectancy and Credibility (TEC)

  Baseline, discharge (at 8 weeks)

Study Arms (1)

Sensory Training

EXPERIMENTAL

Daily protocol - gamified sensory training

Behavioral: Sensory Training

Interventions

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.

Sensory Training

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of musculoskeletal pain including chronic regional pain syndrome
• English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Pediatric Pain Clinic

Menlo Park, California, 94025, United States

Location

Related Publications (11)

• Borkovec, T. D., & Nau, S. D. (1972). Credibility of analogue therapy rationales. Journal of behavior therapy and experimental psychiatry, 3(4), 257-260.

  BACKGROUND

• 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.

  PMID: 35232455 BACKGROUND

• 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.

  PMID: 16051509 BACKGROUND

• 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.

  PMID: 34636750 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 12583873 BACKGROUND

• 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.

  PMID: 18824301 BACKGROUND

• 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.

  PMID: 23133619 BACKGROUND

• 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.

  PMID: 11132119 BACKGROUND

• 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.

  PMID: 27518484 BACKGROUND

• 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.

  PMID: 30496433 BACKGROUND

Study Officials

• Laura Simons, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Perioperative and Pain Medicine

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: September 22, 2023
• Study Start: October 16, 2023
• Primary Completion: January 9, 2025
• Study Completion: January 17, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)