An interventional study of VR- headset in Preoperative Anxiety Score, sponsored by Universitaire Ziekenhuizen KU Leuven. Not yet recruiting. Open to participants aged 13 Years to 19 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Prevention
The purpose of this study is to investigate whether using a Virtual Reality (VR) headset can help young people relax during the placement of an epidural catheter for pain control after pectus surgery.
An epidural catheter is a thin tube that is inserted by the anesthesiologist between two vertebrae in the back. Many teenagers experience anxiety or stress during the placement of this catheter.
To help reduce anxiety, medication called Midazolam can be given through an IV line. However, this does not always provide enough relief. Scientific studies have shown that virtual reality (VR) can help reduce anxiety, stress, and pain during medical procedures. By focusing on a virtual environment, patients are less aware of the procedure itself. In particular, VR has been shown to be a safe and effective way of improving comfort for children and adolescents during medical examinations and treatments.
A total of 78 adolescents aged 13 to 19 years will participate in this study. Participants will be randomly assigned to one of two groups, each consisting of 39 participants:
Children in the interventional group will wear a VR headset during the placement of the epidural catheter. If the child still experiences significant anxiety or stress during the procedure, Midazolam will be administered through the IV line.
Children assigned to the control group will receive the usual care. This means that Midazolam will be given through the IV line if your child experiences significant anxiety or stress. Children in this group will not receive a VR headset.
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children will receive the usual care.
Children will wear a Virtual Reality headset during the placement of the epidural catheter.
Device: VR- headset
Children will wear a VR headset during the placement of the epidural catheter.
Postprocedural anxiety score
Subjective Anxiety/stress measured by the VAS from 0 (no anxiety/distress) and 100mm (extreme anxiety/distress)
Time frame: postprocedural until 10 min after procedure
anxiety assessments by the physician performing the epidural, the assisting nurse and accompanying parent, reflecting their perception of the patient's anxiety (NRS)
measured by the VAS from 0 (no anxiety/distress) and 100mm (extreme anxiety/distress)
Time frame: 10 min preprocedural
anxiety questionnaire from the patient
anxiety questionnaire from the patient
Time frame: 10 min preprocedural
- Rescue sedation medication during placement of the epidural catheter
dose of Midazolam in mg
Time frame: during the procedure
- Efficacy of epidural placement:
Time and number of attempts
Time frame: during the procedure
patient satisfaction score
NRS: from 0-10, 0=not satisfied and 10=very satisfied
Time frame: postprocedural until 10 min after procedure
- Pain score of placement of the epidural catheter
NRS from 0-10, 0=no pain and 10=worst pain)
Time frame: postprocedural until 10 min after procedure
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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