Effectiveness and Implementation of a Digital Intervention for Pediatric Chronic Pain Co-designed With Patients

NCT05917626 | Recruiting

• 1 other identifier: PID2021-122885OA-I00
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 6

Brief Summary

Children and adolescents with chronic pain often lack a proper diagnosis and treatment. Research has shown that, if left untreated, it usually doesn't resolve and continues through adulthood. The goal of this multi-phase study is to co-develop (with patients), test, and implement a smartphone app called "Digital Solution for Pain in Adolescents" (Digital SPA) which can provide pain management resources to children with chronic pain and their parents, preventing future disability. Participants will: participate in individual and group interviews, respond to questionnaires online and try a smartphone app.

Conditions

Chronic Pain

Keywords

Chronic pain; Adolescents; Digital Health; Psychological Intervention; Co-development; Implementation

Outcome Measures

Primary Outcomes (3)

• Change in Pain Interference

  Spanish version of the Brief Pain Inventory (BPI) short version. Pain intensity scale scores range from from 0 to 10 , with higher scores indicating greater interference. Interference scores range from 0 to 10, with higher scores indicating greater interference.

  Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).

• Global impression of change after treatment

  11-point scale (0 to 10) with higher scores indicating greater impression of change.

  Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).

• Change in the number of visits to the Emergency Room (ER) due to pain

  The number of visits to the ER due to pain during the follow-up period (T3 to T4; 3 months) will be compared with the three months before starting treatment (T1).

  Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).

Secondary Outcomes (10)

• Change in pain readiness to change

  Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).

• Change in the dose of pain medication taken

  Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).

• Change in the type of pain medication taken

  Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).

• Change in Emotional Distress

  Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).

• Change in Functional Disability

  Pre-treatment (T1), Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).

Other Outcomes (1)

• Adverse Events (side effects)

  Mid-treatment (T2; 4 weeks after T1), Post-treatment (T3; 8 weeks after T1) and 3-months follow-up (T4; 3 months after T3).

Study Arms (2)

Digital SPA

EXPERIMENTAL

A psychological intervention for chronic pain in adolescents administered using an app co-created with patients.

Behavioral: Digital SPA

Usual Care

NO INTERVENTION

Participants assigned to this arm will receive usual care from their hospital.

Interventions

Digital SPA BEHAVIORAL

A psychological digital intervention for chronic pain in adolescents, based on evidence-based Acceptance and Commitment Therapy techniques. The intervention will be co-created with patients in a previous phase of the study, so the exact number or format of sessions and content has not been determined yet.

Digital SPA

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents age 12-17 years
• Has had non-oncologic chronic pain for at least 3 months (e.g., abdominal pain, headache or musculoskeletal pain)
• Has Internet access
• One parent is willing to participate (and both give consent for their child to participate)

You may not qualify if:

• Diagnosis of a comorbid serious health condition (e.g., cancer)
• Parent or child does not speak or read Spanish
• Active psychosis or suicidal ideation

Sponsors & Collaborators

• University of Malaga: lead
• Ministerio de Ciencia e Innovación, Spain: collaborator

Study Sites (6)

Hospital Materno Infantil Torrecardenas

Almería, Almería, 04009, Spain

RECRUITING

Hospital Sant Joan de Déu

Barcelona, Barcelona, 08950, Spain

RECRUITING

Hospital Materno Infantil Virgen de las Nieves

Granada, Granada, 18014, Spain

RECRUITING

Hospital infantil del Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Hospital General Universitario Santa Lucía

Cartagena, Murcia, 30202, Spain

RECRUITING

Hospital Materno Infantil del Hospital Regional Universitario

Málaga, Málaga, 29006, Spain

RECRUITING

Related Publications (1)

• de la Vega R, Serrano-Ibanez ER, Ruiz-Parraga GT, Palermo TM, Wicksell R, Fernandez-Jimenez E, Oliva S, Roldan S, Monfort L, Pelaez MJ, Leyva Carmona M, Ramirez-Maestre C, Lopez-Martinez AE, Miro J, Esteve R. Protocol for a multi-phase, multi-center, real-world, hybrid effectiveness-implementation study of a digital intervention for pediatric chronic pain co-designed with patients (Digital SPA). Digit Health. 2023 Dec 19;9:20552076231219490. doi: 10.1177/20552076231219490. eCollection 2023 Jan-Dec.

  PMID: 38130799 BACKGROUND

Related Links

• Project website

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rocio de la Vega, PhD

  University of Malaga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rocio de la Vega, PhD

CONTACT

+34634014362; rocio.delavega@uma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * Clinicians referring participants will be unaware of the study phase * Outcomes will be assessed with an online survey
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: "Ramón y Cajal" Researcher; Principal Investigator

Model Details: This study will employ a stepped wedge cluster randomized design in which hospitals are randomized sequentially to initiate the intervention. Prior to initiating patient recruitment, each of the 6 hospitals will be randomized to one of two waves in the stepped wedge design. During the non-exposure periods, patients will receive usual care from the hospital.

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 26, 2023
• Study Start: May 5, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)