NCT07001631 Effect of EMDR for Reduction of Pain Interference in Children With Sickle Cell Disease
| NCT ID | NCT07001631 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Sickle Cell Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-09-20 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-09-20 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Children with sickle cell disease may experience frequent painful episodes. This, together with the traumatic experiences during a hospitalization, can lead to the development of posttraumatic stress reactions. As the stress can trigger painful episodes (pain crisis) in children with sickle cell disease, the investigators think that treating these stress symptoms can reduce the pain-related problems in their lives. Eye Movement Desensitization and Reprocessing (EMDR) is proven to be an effective trauma treatment for posttraumatic stress disorder. Research studies show that EMDR can reduce pain in adults. The investigators want to study now if EMDR effective is in reducing pain-related problems in children with sickle cell disease.
Eligibility Criteria
Inclusion Criteria: * Medical diagnosis of SCD * Age between 6 and 18 years old * Elevated pain interference scores: Reporting above the clinical cut-off T-score of 49 on PROMIS Pain Interference (parent-proxy version for children from 6-7 years and self-report version for children from 8 years). * Having sufficient knowledge of the Dutch or English languages to complete the assessments Exclusion Criteria: * Undergone successful stem cell transplantation * Pregnant adolescents * Current unsafety that is likely to interfere with psychological therapy for example ongoing domestic violence * Major interfering acute medical or psychiatric condition, such as psychosis, substance dependence, current severe self-harm or high risk for suicide requiring immediate treatment * Receiving psychological (trauma) treatment by another therapist at the same time * IQ estimated to be \< 80 based on information contained in the medical history or information from educational services/school
Contact & Investigator
Karin Fijnvandraat, prof. dr.
PRINCIPAL INVESTIGATOR
Amsterdam UMC
Frequently Asked Questions
Who can join the NCT07001631 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07001631 currently recruiting?
Yes, NCT07001631 is actively recruiting participants. Contact the research team at m.c.nery@amsterdamumc.nl for enrollment information.
Where is the NCT07001631 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT07001631 clinical trial?
NCT07001631 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Karin Fijnvandraat, prof. dr. at Amsterdam UMC. The trial plans to enroll 40 participants.
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