Smartphone virtual reality exposure before paediatric surgery (scoliosis)

Smartphone virtual reality exposure before paediatric surgery: effects on pre- and post-procedural pain and anxiety. A multicentre study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33970603

Enrollment

Registered

2024-02-05

Start date

2024-02-19

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain in children undergoing scoliosis surgery Surgery

Interventions

Intervention: Virtual reality environment for pediatric surgical patients The objectives of this study are to assess the efficacy of a virtual reality environment (sVRE) compared to Care As Usual (CAU

this record involves only the scoliosis surgery patients. Participants will be randomly assigned to either the sVRE intervention (n=90) or CAU (n=90). The study includes six measurement points: 1. I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Consecutive pediatric patients 2. Aged 8 up to < 18 years old at baseline 3. Undergoing surgery for scoliosis (either idiopathic scoliosis or non-idiopathic scoliosis patients receiving an open dorsal spinal fusion) between January 2024 and December 2024

Exclusion criteria

Exclusion criteria: 1. Mental retardation 2. Severe visual disability 3. Preoperative use of anxiolytic medication 4. In case of non-idiopathic scoliosis: loss of sensation, for example, caused by spina bifida or paraplegia 5. Inability to read and write Dutch

Design outcomes

Primary

Measure	Time frame
Pain in adolescents undergoing surgery for scoliosis measured using the Faces Pain Scale (FPS-R) and observational Face, Legs, Activity, Cry, Consolability (FLACC) scale at baseline, approximately one week before surgery (T0) and five days postoperatively (T4)	—

Secondary

Measure	Time frame
1. Postoperative analgesic use measured using data collected from medical records (analgesics given during hospitalization) and via a questionnaire for the parents (analgesics use at home) 2. Pre-operative anxiety measured using the modified Yale Preoperative Anxiety Scale (mYPAS) 3. Anxiety measured using the Numeric Rating Scale (NRS) 4. Compliance with the induction of anaesthesia measured using the Induction Compliance Checklist (ICC) 5. The user experience measured using a self-developed questionnaire 6. Sleep measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance item bank. For children aged 8 years and older, a self-report children’s version of the PROMIS Sleep Disturbance scale will be used. The study will investigate whether the following factors influence smartphone VR effectivity: 1. Medical outcomes including the type of surgery, ASA score, analgesic use and length of hospital stay measured using data collected from the child’s medical file 2. Socio-demographic data such as sex and age of the child, presence of brothers/sisters who have been operated on, socioeconomic status and the number of prior surgeries of the child measured using data collected from a baseline questionnaire completed by the parent. The secondary objective is to identify which variables predict the efficacy of sVRE. Predictor variables that will be examined are at: 1. Socioeconomic status (SES) (questionnaire timepoint T0) 2. Age (questionnaire timepoint T0) 3. Sex (questionnaire timepoint T0) 4. Type of surgery (questionnaire timepoint T0) 5. Number of prior surgeries (questionnaire timepoint T0) 6. Preoperative child anxiety (NRS timepoint T0, T1) 7. Preoperative parental anxiety (mYPAS timepoint T0) 8. Sleep problems before surgery (PROMIS, T0)	—

Measure

Time frame

1. Postoperative analgesic use measured using data collected from medical records (analgesics given during hospitalization) and via a questionnaire for the parents (analgesics use at home) 2. Pre-operative anxiety measured using the modified Yale Preoperative Anxiety Scale (mYPAS) 3. Anxiety measured using the Numeric Rating Scale (NRS) 4. Compliance with the induction of anaesthesia measured using the Induction Compliance Checklist (ICC) 5. The user experience measured using a self-developed questionnaire 6. Sleep measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance item bank. For children aged 8 years and older, a self-report children’s version of the PROMIS Sleep Disturbance scale will be used. The study will investigate whether the following factors influence smartphone VR effectivity: 1. Medical outcomes including the type of surgery, ASA score, analgesic use and length of hospital stay measured using data collected from the child’s medical file 2. Socio-demographic data such as sex and age of the child, presence of brothers/sisters who have been operated on, socioeconomic status and the number of prior surgeries of the child measured using data collected from a baseline questionnaire completed by the parent. The secondary objective is to identify which variables predict the efficacy of sVRE. Predictor variables that will be examined are at: 1. Socioeconomic status (SES) (questionnaire timepoint T0) 2. Age (questionnaire timepoint T0) 3. Sex (questionnaire timepoint T0) 4. Type of surgery (questionnaire timepoint T0) 5. Number of prior surgeries (questionnaire timepoint T0) 6. Preoperative child anxiety (NRS timepoint T0, T1) 7. Preoperative parental anxiety (mYPAS timepoint T0) 8. Sleep problems before surgery (PROMIS, T0)

—

Countries

Netherlands

Contacts

Public ContactBram Dierckx

b.dierckx@erasmusmc.nl+31 0107040209

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026