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Sickle Cell DiseaseRELAXNCT07001631

Effect of EMDR for Reduction of Pain Interference in Children With Sickle Cell Disease

A study testing Eye Movement Desensitization and Reprocessing (EMDR) in people with Sickle Cell Disease and Pain, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Sickle Cell Disease, Pain, Pain, Chronic Disease
What is being tested?
Eye Movement Desensitization and Reprocessing (EMDR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteNetherlands
Study dates
20 Sep 2024to 1 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Netherlands1 site, 1 recruiting
  • Amsterdam UMC

    Amsterdam

    Mariana Nery, +31 020 - 5666462, m.c.nery@amsterdamumc.nl

    Recruiting

Other trials in Netherlands

About this study

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.

Read the detailed description

Objective: The primary objective of this study is to investigate the efficacy of EMDR therapy in reducing pain interference in the lives of children with SCD. Secondary objectives are to study the efficacy of EMDR in reducing PTSD symptoms, anxiety, depressive symptoms, physical complaints (low mobility), frequency and severity of pain, use of pain medication, and number of days absent from school. Themes of pain and trauma-related memories and feasibility of EMDR therapy for this population will also be explored.

Study design: In this single-center randomized controlled trial (RCT) patients (aged 6-18 years) with SCD and clinically relevant scores on PROMIS pain interference will be randomized into an intervention group and waiting list control group. Measurements will be done for the complete study population at inclusion (T0). In the intervention group, measurements will be done 2 weeks (T1i) and 3 months (T2i) after the end of EMDR sessions. Eight weeks after inclusion (T1c) will be performed for participants in the waiting list control group just before they receive EMDR treatment, and they are asked to complete measurements, 2 weeks (T1.1c) and 3 months after the end of EMDR sessions (T2c).

Intervention: After the intake session (week 1), including case conceptualization and treatment plan, a maximum of 6 weekly EMDR sessions with a duration of 1 hour per session will be offered. The waiting list control group will wait 9 weeks before starting EMDR therapy.

Being tested
Eye Movement Desensitization and Reprocessing (EMDR)
Keywords
Pain, Pain Interference, Vaso-occlusive crisis, EMDR, PTSD
Medical subject headings
Anemia, Sickle Cell, Pain, Chronic Disease, Vaso-Occlusive Crises, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eye Movement Desensitization and Reprocessing (EMDR)Other

    Also called EMDR therapy, EMDR treatment

    The Dutch version of the standard EMDR protocol with age-specific adaptations for children and adolescents will be used. The eight phases consist of history taking, preparation, assessment, desensitization, installation, body scan, closure, and re-evaluation. During an EMDR session, the child focuses on emotionally disturbing memories (images, thoughts, emotions, and sensations) while simultaneously focusing on an external distracting stimulus (e.g., eye movements). This process facilitates accessing and desensitizing the traumatic memory network, so information processing is enhanced, and new associations can be made between the traumatic memory and more adaptive memories and information. As a result, the traumatic memory representation will be less intense and emotionally disturbing. After the intake session (week 1), including case conceptualization and treatment plan, a maximum of 6 weekly EMDR sessions with a duration of 1 hour per session will be offered.

Study groups in NCT07001631
Study groupRoleWhat they receive
EMDR intervention groupActive comparatorMeasurements will be done for the complete study population at inclusion (T0). Participants randomized to the intervention group will start the EMDR therapy as soon as possible. After the intake session (week 1), including case conceptualization and treatment plan, a maximum of 6 weekly EMDR sessions with a duration of 1 hour per session will be offered. In the intervention group, measurements will be done 2 weeks (T1i) and 3 months (T2i) after the end of EMDR sessions.
Receives: Other: Eye Movement Desensitization and Reprocessing (EMDR)
Wait-list control groupOtherMeasurements will be done for the complete study population at inclusion (T0). Participants randomized to wait-list control group will wait for 9 weeks to start the therapy. Eight weeks after inclusion (T1c) will be performed for participants in the wait-list control group, just before they receive EMDR treatment. After the intake session (week 1), including case conceptualization and treatment plan, a maximum of 6 weekly EMDR sessions with a duration of 1 hour per session will be offered. Participants of the wait-list control group are asked to complete measurements 2 weeks (T1.1c) and 3 months after the end of EMDR sessions (T2c).
Receives: Other: Eye Movement Desensitization and Reprocessing (EMDR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain interference

    The PROMIS Short Form - Pain Interference 8a for measuring Pain Interference will be used. The PROMIS Pain Interference questionnaire assesses the pain impact on relevant aspects of one's life. This includes the extent to which pain affects social, cognitive, emotional, physical, and recreational activities. It also incorporates items probing sleep and enjoyment in life. The questionnaire assesses pain interference over the past seven days (recall period). A higher PROMIS T-score represents more pain interference. This scale ranges from 0 to 100 points. In his dissertation, Luijten reports that the general Dutch pediatric population reports a mean score of 39 points with a standard deviation of 10 points. Therefore, T-scores of 49 and above represent a (sub)clinical level of functioning. On a previous study from our group, children with severe SCD phenotype (n= 36) reported a mean score of 52.73 points (SD= 12.72), while the ones with less severe SCD phenotype (n= 54).

    Measured: Tscreen, inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2)

Secondary outcomes (8)
  1. PTSD symptoms

    The efficacy of EMDR in reducing PTSD symptoms. The Child and Adolescent Trauma Screen (CATS) questionnaire is a screening instrument based on the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for PTSD. It measures potentially traumatic events and PTSD symptoms (PTSS). The questionnaire consists of 15 items measuring traumatic events, 20 items measuring DSM-5 PTSD symptoms, and 5 items measuring psychosocial functioning, and it is administered in approximately 15 minutes. The 4-point symptom response scales indicate the reported frequency/severity of each symptom.

    For children aged 6-7 years, using the caregiver-report version, the possible score range is 0-48, and the recommended cut-off point indicative of (sub)clinically relevant levels of symptoms is 12 points or more. For children aged 8 years and older, using the self-report version, the possible score range is 0-60, and the cut-off point is 15 points or more.

    Measured: Tscreen, inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2)

  2. Anxiety

    The efficacy of EMDR in reducing anxiety. PROMIS Anxiety questionnaires assess fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). They assess anxiety over the past seven days (recall period). PROMIS T-scores are calculated per version, with higher T-scores representing greater anxiety.

    Measured: Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2)

  3. Depressive symptoms

    The efficacy of EMDR in reducing depressive symptoms. PROMIS Depressive Symptoms questionnaires assess negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). Somatic symptoms (changes in appetite, sleeping patterns) are not included, which eliminates consideration of these item's confounding effects when assessing children with comorbid physical conditions. The questionnaires are universal rather than disease-specific, making scores easily comparable to the general population. They assess depressive symptoms over the past seven days (recall period). The PROMIS T-scores are calculated per version. A higher PROMIS T-score represents more depressive symptoms.

    Measured: Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2)

  4. Physical complaints (low moblity)

    The efficacy of EMDR in reducing physical complaints. These questionnaires assess activities of physical mobility such as getting out of bed or a chair to activities such as running. They assess mobility over the past seven days (recall period). The PROMIS T-scores are calculated per version. A higher PROMIS T-score represents more mobility.

    Measured: Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2)

  5. Pain frequency

    The efficacy of EMDR in reducing pain frequency. At T0, T1i/T1.1c, T1c and T2, participants should complete a diary and report for each day of the week if they had pain (yes/no).

    Measured: Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2)

  6. Pain severity

    The efficacy of EMDR in reducing pain severity. At T0, T1i/T1.1c, T1c and T2, participants should complete a diary and rate, for each day of the week that they had pain, the severity of the pain on a numeric rating scale (NRS, 0 - 10, 10 indicating the highest pain). It will also be investigated before and after each EMDR session using the same NRS, and will be registered by the therapist as part of the session report.

    Measured: Inclusion (T0), before and after each EMDR session, 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2).

  7. Use of pain medication

    The efficacy of EMDR in reducing pain medication use. At T0, T1i/T1.1c, T1c and T2, participants should complete a diary and report for each day of the week any pain medication used. The (multiple-choice) options available are: no pain medication, paracetamol, diclofenac/ibuprofen, tramadol.

    Measured: Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2).

  8. School absence

    The efficacy of EMDR in reducing school absence. At T0, T1i/T1.1c, T1c and T2, participants should complete a diary and report for each day of the week if they went to school (yes/no; if 'no' is chosen, they can also answer why, in a free text format).

    Measured: Inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2025
  2. Study start20 Sep 2024
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07001631
Sponsor's protocol ID
NL86274.018.24
Other IDs
RELAX
Acronym
RELAX
Status last verified
Mar 2025
First submitted
28 Apr 2025
Last updated
3 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Nery M, Scholten L, Voorrips C, de Roos C, Fijnvandraat K, Haverman L. Effect of EMDR for reduction of pain interference in children with sickle cell disease, the RELAX study: a randomized controlled trial protocol. BMC Pediatr. 2026 Aug 27;26(1):797. doi: 10.1186/s12887-026-07153-2.

    PubMed 42649491

Questions about this trial

What is this clinical trial studying?

A study testing Eye Movement Desensitization and Reprocessing (EMDR) in people with Sickle Cell Disease and Pain, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mariana Nery, MD (+31 020 - 5666462, m.c.nery@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain interference (time frame: Tscreen, inclusion (T0), 2 weeks after end of treatment (T1i/T1.1c) or 8 weeks after inclusion (T1c), 3 months after end of treatment (T2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07001631, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.

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