Effect of EMDR for reduction of pain interference in children with sickle cell disease, the RELAX study: a randomized controlled trial protocol

BACKGROUND: Children with sickle cell disease (SCD) suffer from vaso-occlusive crises, extremely painful episodes that may require hospitalization. Traumatic experiences during hospitalization and frequent pain experiences may lead to psychological distress and the development of (subclinical) posttraumatic stress disorder (PTSD). Children with SCD also experience elevated pain interference (the negative impact of pain on daily life), which research suggests may be more strongly associated with psychological than biological factors. Due to the association between psychological distress and pain, Eye Movement Desensitization and Reprocessing (EMDR), originally developed for treating PTSD, has recently been investigated for its potential to reduce pain. However, its effectiveness has not been studied for children and for SCD populations with the aim of reduction in pain interference. METHODS: In this single-center randomized controlled trial children and adolescents (aged 6-18 years) with SCD and clinical relevant scores on pain interference will be randomized to either EMDR therapy (n = 20) or waiting list control group (n = 20). Waiting list participants were reallocated to EMDR after 9 weeks. Follow-up was conducted 3-months post-treatment. Primary outcome is pain interference. Secondary outcomes include PTSD symptoms, anxiety and depressive symptoms, physical mobility, number of painful days, pain intensity, pain medication use and school absence, with additional outcomes assessing themes of pain and trauma-related memories and EMDR feasibility. DISCUSSION: This paper outlines the study protocol of a randomized controlled trial aiming to investigate the efficacy of EMDR therapy in reducing pain interference in the lives of children with SCD. If proven effective, this will be a promising intervention to reduce pain interference and chronic pain experienced by this group, with the advantage of being a non-pharmacological and non-invasive intervention. This method may also hold potential for children living with chronic pain of other causes. TRIAL REGISTRATION: clinicaltrials.gov, NCT07001631, retrospectively registered on May 23rd 2025, clinicaltrials.gov/study/NCT07001631.