Children with sickle cell disease (SCD) experience recurrent vaso-occlusive crises that cause intense pain and often require hospitalization. These acute painful episodes and the associated medical events can be traumatic and contribute to psychological distress, including subclinical or clinical posttraumatic stress disorder (PTSD). Research suggests that elevated pain interference—the impact of pain on daily functioning—may be more closely associated with psychological factors than with biological disease markers in this population.
Eye Movement Desensitization and Reprocessing (EMDR) is a psychotherapeutic intervention originally developed to treat PTSD. Recent investigations have explored EMDR’s potential to reduce pain, given the links between traumatic memories, psychological distress, and chronic pain. However, before the RELAX study, EMDR had not been evaluated specifically for children with SCD with the explicit aim of reducing pain interference.
The RELAX study is described as a single-center randomized controlled trial. The protocol published in BMC Pediatrics outlines a randomized comparison of EMDR therapy versus a waiting-list control in a pediatric SCD population. The study was conducted at Amsterdam UMC, with affiliations across child and adolescent psychiatry, pediatric hematology, and public health departments noted for the author group.
Eligible participants are children and adolescents aged 6 to 18 years with SCD who have clinically relevant scores on measures of pain interference. The abstract reports planned group sizes of 20 participants allocated to the EMDR arm and 20 participants allocated to the waiting-list control arm, for a total of 40 randomized participants. Additional details on recruitment, inclusion and exclusion criteria, and baseline assessments were not reported in the abstract and would require consulting the full protocol.
Participants randomized to the intervention arm receive EMDR therapy. Those randomized to the waiting-list control are reallocated to receive EMDR after a 9-week waiting period. The protocol includes follow-up assessments 3 months after treatment completion. Specifics on the number and duration of EMDR sessions, the therapeutic protocol used, therapist training or fidelity monitoring, and delivery location are not detailed in the abstract and are reported in the full protocol.
The primary outcome of the RELAX trial is pain interference, measured by clinically relevant instruments (exact instruments not specified in the abstract). Secondary outcomes include:
Additional outcomes described in the abstract assess themes of pain- and trauma-related memories and the feasibility of delivering EMDR in this population. The abstract does not provide specific measurement tools, timing of outcome assessments beyond the 3-month follow-up, or sample size justification; these methodological details are expected to be described in the full trial protocol.
The trial is registered on ClinicalTrials.gov under identifier NCT07001631; registration was posted retrospectively on May 23, 2025. Ethical approval and consent procedures were approved by the Amsterdam UMC medical ethical committee (NL86274.018.24). The conflict of interest statement notes that one author (CdeR) receives income from a published book about EMDR therapy and provides EMDR training for postdoctoral professionals; the other authors declare no competing interests.
The protocol frames EMDR as a promising non-pharmacological and non-invasive approach to reduce pain interference and potentially chronic pain burden among children and adolescents with SCD. If EMDR demonstrates efficacy for reducing pain interference in this randomized trial, the intervention could offer an adjunctive treatment option that targets psychological contributors to pain and daily functioning. The authors also suggest that positive findings may have broader relevance for children living with chronic pain from other causes.
The abstract does not report trial results, effect estimates, or detailed methodology such as randomization procedures, blinding, statistical analysis plans, or therapist credentialing. For full methodological transparency, outcome measurement instruments, sample size calculations, intervention manuals, and results, readers should consult the full published protocol and subsequent trial reports.