RELAX: Effect of EMDR for reduction of pain interference in children with sickle cell disease

Primary outcomes is pain interference in the child*s life, measured with PROMIS

Pain Interference questionnaire.



PROMIS Pain Interference (parent-report for children aged 6-7 and pediatric

self-report from 7 years on):

We will use the PROMIS Short Form - Pain Interference 8a for measuring Pain

interference. The PROMIS Pain Interference questionnaire assess 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 0-100

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 (sub)clinical level of

functioning. On previous study from our group (submitted), 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) reported a mean score of

47.35 points (SD= 13.82).

• Severity of PTSD symptoms during/after intervention:

PTSD symptoms score reported via the Child and Adolescent Trauma Screen (CATS)

questionnaire (parent-report for children aged 6-7 and pediatric self-report

from 7 years on):

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 is a measure of potentially

traumatic events and of PTSS. These questionnaires are composed of 15 items

measuring traumatic events, 20 items measuring DSM-5 PTSD symptoms, and 5 items

measuring psychosocial functioning, and is administered in approximately 15

minutes. The 4-point symptom response scales indicate the reported

frequency/severity of each symptom. For the children aged 6 years, using the

Caregiver-report, the possible score range is 0 - 48, and the recommended

cut-off point indicative of (sub)clinically relevant level of symptoms is of 12

points or more. For children aged 7 years and older, using the Self-report

version, the possible score range is 0 - 60, and the cut-off point is of 15

points or more.



• Anxiety of participants (parent-report for children aged 6-7 and pediatric

self-report from 7 years on):

General anxiety score reported via PROMIS Anxiety questionnaire:

PROMIS Anxiety questionnaires assess the 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). The PROMIS T-scores are

calculated per version. A higher PROMIS T-score represents more anxiety.



• Depressive symptoms of participants (parent-report for children aged 6-7

and pediatric self-report from 7 years on):

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.



• Physical complaints (parent-report for children aged 6-7 and pediatric

self-report from 7 years on):

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.



• Pain severity and intensity, pain medication and school absence:

At 3 measurement moments (T0, T1, T1.1. and T2) participants, should complete

a diary and report for each day of the week if they had pain and rate the

severity of the pain on a numeric rating scale (NRS), and any pain medication

used and if they went to school.

Pain severity will also be investigated before and after each EMDR session

using the same measurement tool, and will be registered by the therapist as

part of the session report.



• Feasibility of EMDR intervention:

At T1i/T1.1c (2 weeks after the last EMDR session), the EMDR treatment

feasibility will be evaluated via a semi-structured interview performed by the

researcher with the participants.