Development, implementation and evaluation of a digital treatment for adolescents with chronic pain: a protocol for a multi-phase study

doi:10.3389/fdgth.2025.1555733

. 2025 Jun 4:7:1555733.

doi: 10.3389/fdgth.2025.1555733. eCollection 2025.

Development, implementation and evaluation of a digital treatment for adolescents with chronic pain: a protocol for a multi-phase study

Jordi Miró^{1

2}, Ariadna Sampietro^{1

2}, Sonia Monterde^{1

2

3}, Pablo Ingelmo^{4

5

6}, Rikard K Wicksell^{7

8}, Carme Nolla^{1

2

9}, Mercedes Alonso¹⁰, Juan José Lázaro¹¹, Ernesto Martínez¹², Paloma Rubio¹³, Armando Sánchez¹⁴, Vanessa Sánchez¹⁵, Alvaro Vázquez¹⁶, Rocío de la Vega^{17

18}, Francisco Reinoso-Barbero¹⁰

Affiliations

¹ Unit for the Study and Treatment of Pain-ALGOS, Research Center for Behavior Assessment (CRAMC), Department of Psychology, Universitat Rovira I Virgili, Tarragona, Spain.
² Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira I Virgili, Tarragona, Spain.
³ Unit of Physical Therapy, Department of Medicine and Surgery, Faculty of Medicine and Health Sciences, Universitat Rovira I Virgili, Tarragona, Spain.
⁴ Department of Anesthesiology, Montreal Children's Hospital, The Edwards Family Interdisciplinary Centre for Complex Pain, Montreal, QC, Canada.
⁵ Department of Anesthesia, McGill University, Montreal, QC, Canada.
⁶ Research Institute, Alan Edwards Centre for Research on Pain, McGill University Health Center, Montreal, QC, Canada.
⁷ Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
⁸ Pain Clinic, Capio St Göran Hospital, Stockholm, Sweden.
⁹ Health Care Center Xarxa Tecla, Tarragona, Spain.
¹⁰ Pediatric Pain Unit, Pediatric Anesthesiology Department, La Paz University Hospital, Madrid, Spain.
¹¹ Department of Anaesthesia and Pain Therap, Hospital Sant Joan de Déu, Barcelona, Spain.
¹² Department of Anesthesia, Children University Hospital Niño Jesús, Madrid, Spain.
¹³ Pediatric Chronic Pain Unit, Anesthesia Department, 12 de Octubre Universitary Hospital, Madrid, Spain.
¹⁴ Pediatric Pain Unit, Pediatric Anaesthesiology Section, Critical Care and Pain Therapy Department, Miguel Servet University Hospital, Zaragoza, Spain.
¹⁵ Servei d'Anestesiologia, Reanimació I Tractament del Dolor, Hospital Infantil I Hospital de la Dona, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
¹⁶ Servicio de Anestesiología y Reanimación, Unidad de Dolor, Hospital Universitari Son Espases, Palma, Spain.
¹⁷ Department of Personality, Evaluation, and Psychological Treatment, Faculty of Psychology and Speech Therapy, University of Málaga, Málaga, Spain.
¹⁸ Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA Plataforma BIONAND), Málaga, Spain.

PMID: 40534825
PMCID: PMC12174134
DOI: 10.3389/fdgth.2025.1555733

Development, implementation and evaluation of a digital treatment for adolescents with chronic pain: a protocol for a multi-phase study

Jordi Miró et al. Front Digit Health. 2025.

. 2025 Jun 4:7:1555733.

doi: 10.3389/fdgth.2025.1555733. eCollection 2025.

Authors

Affiliations

¹ Unit for the Study and Treatment of Pain-ALGOS, Research Center for Behavior Assessment (CRAMC), Department of Psychology, Universitat Rovira I Virgili, Tarragona, Spain.
² Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira I Virgili, Tarragona, Spain.
³ Unit of Physical Therapy, Department of Medicine and Surgery, Faculty of Medicine and Health Sciences, Universitat Rovira I Virgili, Tarragona, Spain.
⁴ Department of Anesthesiology, Montreal Children's Hospital, The Edwards Family Interdisciplinary Centre for Complex Pain, Montreal, QC, Canada.
⁵ Department of Anesthesia, McGill University, Montreal, QC, Canada.
⁶ Research Institute, Alan Edwards Centre for Research on Pain, McGill University Health Center, Montreal, QC, Canada.
⁷ Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
⁸ Pain Clinic, Capio St Göran Hospital, Stockholm, Sweden.
⁹ Health Care Center Xarxa Tecla, Tarragona, Spain.
¹⁰ Pediatric Pain Unit, Pediatric Anesthesiology Department, La Paz University Hospital, Madrid, Spain.
¹¹ Department of Anaesthesia and Pain Therap, Hospital Sant Joan de Déu, Barcelona, Spain.
¹² Department of Anesthesia, Children University Hospital Niño Jesús, Madrid, Spain.
¹³ Pediatric Chronic Pain Unit, Anesthesia Department, 12 de Octubre Universitary Hospital, Madrid, Spain.
¹⁴ Pediatric Pain Unit, Pediatric Anaesthesiology Section, Critical Care and Pain Therapy Department, Miguel Servet University Hospital, Zaragoza, Spain.
¹⁵ Servei d'Anestesiologia, Reanimació I Tractament del Dolor, Hospital Infantil I Hospital de la Dona, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
¹⁶ Servicio de Anestesiología y Reanimación, Unidad de Dolor, Hospital Universitari Son Espases, Palma, Spain.
¹⁷ Department of Personality, Evaluation, and Psychological Treatment, Faculty of Psychology and Speech Therapy, University of Málaga, Málaga, Spain.
¹⁸ Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA Plataforma BIONAND), Málaga, Spain.

PMID: 40534825
PMCID: PMC12174134
DOI: 10.3389/fdgth.2025.1555733

Abstract

Chronic pain in adolescents is an increasing public health concern with a significant physical, psychological, and social impact. This study aims to develop, implement, and evaluate DigiDOL-Ad, a digital psychosocial treatment for adolescents with chronic pain, supplemented by dedicated websites for their parents and teachers. This multicenter study will be conducted in four phases: (1) Development of the intervention framework and foundational planning; (2) Focus groups with adolescents with chronic pain, their parents, teachers, healthcare professionals and health authorities to identify specific needs and tailor the psychosocial treatment and related components; (3) Iterative usability testing of the digital treatment, using an a hermeneutical circle methodology to refine the design based on participant feedback; and (4) Evaluation of DigiDOL-Ad through a pre-treatment, post-treatment, and 3-month follow-up assessment. DigiDOL-Ad has the potential to improve the quality of life for adolescents with chronic pain. By leveraging digital health technologies, this innovative approach could establish a new benchmark for treating adolescents with chronic pain, emphasizing interdisciplinary and stakeholder-driven care.

Clinical trial registration: clinicaltrials.gov, identifier NCT06765200.

Keywords: adolescents; chronic pain; digital health; digital therapeutics; mobile application; pain management.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

**Figure 1**
Summary of study procedures.

**Figure 2**
Schedule of enrolment, intervention and assessments for phase 4. t₁ = enrollment; t₁ = pre-treatment assessment_; t_1.1−1.8 = weekly check-ins; t₂ = post-treatment assessment; t₃ = 3-month follow-up assessment.

See this image and copyright information in PMC

References

1. Miró J, Roman-Juan J, Sánchez-Rodríguez E, Solé E, Castarlenas E, Jensen MP. Chronic pain and high impact chronic pain in children and adolescents: a cross-sectional study. J Pain. (2023) 24:812–23. 10.1016/j.jpain.2022.12.007 - DOI - PubMed
1. Roy R, Galán S, Sánchez-Rodríguez E, Racine M, Solé E, Jensen MP, et al. Cross-national trends of chronic back pain in adolescents: results from the HBSC study, 2001–2014. J Pain. (2022) 23:123–30. 10.1016/j.jpain.2021.07.002 - DOI - PubMed
1. Roman-Juan J, Solé E, Sánchez-Rodríguez E, Castarlenas E, Jensen MP, Miró J. Validation of the pediatric version of the graded chronic pain scale revised in school-aged children and adolescents. Pain. (2023) 164:2606–14. 10.1097/j.pain.0000000000002965 - DOI - PubMed
1. Chambers CT, Dol J, Tutelman PR, Langley CL, Parker JA, Cormier BT, et al. The prevalence of chronic pain in children and adolescents: a systematic review update and meta-analysis. Pain. (2024) 165:2215–34. 10.1097/j.pain.0000000000003267 - DOI - PMC - PubMed
1. Huguet A, Miró J. The severity of chronic pediatric pain: an epidemiological study. J Pain. (2008) 9:226–36. 10.1016/j.jpain.2007.10.015 - DOI - PubMed

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[1] Miró J, Roman-Juan J, Sánchez-Rodríguez E, Solé E, Castarlenas E, Jensen MP. Chronic pain and high impact chronic pain in children and adolescents: a cross-sectional study. J Pain. (2023) 24:812–23. 10.1016/j.jpain.2022.12.007 - DOI - PubMed

[2] Miró J, Roman-Juan J, Sánchez-Rodríguez E, Solé E, Castarlenas E, Jensen MP. Chronic pain and high impact chronic pain in children and adolescents: a cross-sectional study. J Pain. (2023) 24:812–23. 10.1016/j.jpain.2022.12.007 - DOI - PubMed

[3] Roy R, Galán S, Sánchez-Rodríguez E, Racine M, Solé E, Jensen MP, et al. Cross-national trends of chronic back pain in adolescents: results from the HBSC study, 2001–2014. J Pain. (2022) 23:123–30. 10.1016/j.jpain.2021.07.002 - DOI - PubMed

[4] Roy R, Galán S, Sánchez-Rodríguez E, Racine M, Solé E, Jensen MP, et al. Cross-national trends of chronic back pain in adolescents: results from the HBSC study, 2001–2014. J Pain. (2022) 23:123–30. 10.1016/j.jpain.2021.07.002 - DOI - PubMed

[5] Roman-Juan J, Solé E, Sánchez-Rodríguez E, Castarlenas E, Jensen MP, Miró J. Validation of the pediatric version of the graded chronic pain scale revised in school-aged children and adolescents. Pain. (2023) 164:2606–14. 10.1097/j.pain.0000000000002965 - DOI - PubMed

[6] Roman-Juan J, Solé E, Sánchez-Rodríguez E, Castarlenas E, Jensen MP, Miró J. Validation of the pediatric version of the graded chronic pain scale revised in school-aged children and adolescents. Pain. (2023) 164:2606–14. 10.1097/j.pain.0000000000002965 - DOI - PubMed

[7] Chambers CT, Dol J, Tutelman PR, Langley CL, Parker JA, Cormier BT, et al. The prevalence of chronic pain in children and adolescents: a systematic review update and meta-analysis. Pain. (2024) 165:2215–34. 10.1097/j.pain.0000000000003267 - DOI - PMC - PubMed

[8] Chambers CT, Dol J, Tutelman PR, Langley CL, Parker JA, Cormier BT, et al. The prevalence of chronic pain in children and adolescents: a systematic review update and meta-analysis. Pain. (2024) 165:2215–34. 10.1097/j.pain.0000000000003267 - DOI - PMC - PubMed

[9] Huguet A, Miró J. The severity of chronic pediatric pain: an epidemiological study. J Pain. (2008) 9:226–36. 10.1016/j.jpain.2007.10.015 - DOI - PubMed

[10] Huguet A, Miró J. The severity of chronic pediatric pain: an epidemiological study. J Pain. (2008) 9:226–36. 10.1016/j.jpain.2007.10.015 - DOI - PubMed

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Development, implementation and evaluation of a digital treatment for adolescents with chronic pain: a protocol for a multi-phase study

Affiliations

Development, implementation and evaluation of a digital treatment for adolescents with chronic pain: a protocol for a multi-phase study

Authors

Affiliations

Abstract

Conflict of interest statement

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Abstract

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