Sickle cell disease
Conditions
Interventions
Control group (standard care + tablet): 3 tablet-session per day, lasting 15
minutes. Before and after every session they will answer about their pain and
anxiety level. Every day they will answer a
Sponsors
Amsterdam UMC
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Medical diagnosis of SCD; • Age between 8 and 25 years old; • Diagnosed with a current VOC; • With moderate or severe pain reported (4 points or more in NRS); • Capable to read in English or Dutch; • Written informed consent
Exclusion criteria
Exclusion criteria: • Refused informed consent; • Pregnant women; • Admission for other reason than VOC; • Patients with history of opiate addiction; • Blindness or significantly impaired vision.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study parameter: • Level of pain reported via NRS. Endpoint: • The main endpoint of this study is the pain intensity in SCD patients hospitalized because of a VOC directly before and after the use of intervention and the pattern of pain intensity during hospitalization in both groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Anxiety of patients: Study parameter: • Level of general anxiety reported via PROMIS Anxiety Short-form 8a/PROMIS Anxiety Pediatric Custom Short-form 8, measured in the first 24h of admission and at discharge; and via 1 item from PROMIS Anxiety Pediatric Custom Short-form 8 questionnaire (*I felt scared**), measured directly before and after the use of intervention Endpoint: • Statistical difference between groups in the general anxiety level in SCD patients hospitalized because of a VOC. Pain medication: Study parameter: • Total opioid medication dosage during hospitalization (continuous use - data from patient*s electronic record - and PCA pump). Endpoint: • Statistical difference between groups in the total opioid medication used by patients during hospitalization because of a VOC. Length of stay (LOS): Study parameter: • Total LOS (data from patient*s electronic record). Endpoint: • Statistical difference between groups in the total LOS for a VOC management. Complications: Study parameter: • Presence of ACS, need for blood transfusion and admission to (P)ICU (data from patient*s electronic record). Endpoint: • Statistical difference between groups in the total incidence of complications during hospitalization because of a VOC. VR experience: Study parameter: • VR experience interview. Endpoints: • Qualitative assessment of VR sessions* feasibility, acceptability, tolerability and satisfaction. Tablet experience: Study parameter: • Tablet experience interview. Endpoints: • Qualitative assessment of the feasibility, acceptability and satisfaction of tablet sessions Cost-effectiveness: Study parameter: • Health Technology Assessment based, among others, on health-related quality of life reported via EQ-5D questionnaire and on how many days are the parents/companion absent from work because of the hospitalization Endpoints: • Assessment of cost-effectiveness of VR technology. | — |
Countries
Netherlands
Outcome results
None listed