Preoperative Anxiety ScoreNCT07911436
Virtual Reality to Reduce Anxiety During Thoracic Epidural Placement.
A study testing VR- headset in people with Preoperative Anxiety Score, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Preoperative Anxiety Score
- What is being tested?
- VR- headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Aug 2028
- 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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Voluntary written informed assent of the minor participant + consent of their legally authorized representative or voluntary written informed consent of the adult participant has been obtained prior to any screening procedures
- Between 13 \& 19 years of age at the time of signing the Informed Consent Form (ICF)
- Scheduled for elective Pectus Excavatum or Carinatum repair (Nuss/Ravitch) with planned Thoracic Epidural Analgesia (TEA).
- ASA I-III
- Proficiency in Dutch to allow self-assessment via VAS-Anxiety
Who cannot join
- Patient has history of Epilepsy or Seizure Disorder
- Regular use of anxiolytics, sedatives, or psychoactive medication at home.
- Deafness or blindness preventing VR engagement or VAS self-assessment.
- Known contraindication to TEA (e.g., coagulopathy) or refusal of TEA.
- Urgent or emergency surgery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Virtual Reality Distraction on Procedural Anxiety in Adolescents Undergoing Epidural Placement for Pectus Surgery: An Open-Label Prospective Randomized Controlled Trial.
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.
Read more
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.
- Conditions
- Preoperative Anxiety Score
- Being tested
- VR- headset
- Keywords
- Epidural katheter, Preoperative anxiety, virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR- headsetDevice
Children will wear a VR headset during the placement of the epidural catheter.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Children will receive the usual care. |
| Interventional group | Experimental | Children will wear a Virtual Reality headset during the placement of the epidural catheter. Receives: Device: VR- headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprocedural anxiety score
Subjective Anxiety/stress measured by the VAS from 0 (no anxiety/distress) and 100mm (extreme anxiety/distress)
Measured: postprocedural until 10 min after procedure
Secondary outcomes (6)
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)
Measured: 10 min preprocedural
anxiety questionnaire from the patient
anxiety questionnaire from the patient
Measured: 10 min preprocedural
- Rescue sedation medication during placement of the epidural catheter
dose of Midazolam in mg
Measured: during the procedure
- Efficacy of epidural placement:
Time and number of attempts
Measured: during the procedure
patient satisfaction score
NRS: from 0-10, 0=not satisfied and 10=very satisfied
Measured: 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)
Measured: postprocedural until 10 min after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Anxiety ScoreStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911436
- Sponsor's protocol ID
- S71981
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Reality Distraction on Procedural Anxiety in Adolescents Undergoing Epidural Placement for Pectus Surgery: An Open-Label Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07911436
- Acronym / sponsor ID
- S71981
- Conditions
- Preoperative Anxiety Score
- Keywords
- Epidural katheter, Preoperative anxiety, virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Children will receive the usual care. |
| Interventional group | Experimental | Device: VR- headsetChildren will wear a Virtual Reality headset during the placement of the epidural catheter. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Voluntary written informed assent of the minor participant + consent of their legally authorized representative or voluntary written informed consent of the adult participant has been obtained prior to any screening procedures
- Between 13 \& 19 years of age at the time of signing the Informed Consent Form (ICF)
- Scheduled for elective Pectus Excavatum or Carinatum repair (Nuss/Ravitch) with planned Thoracic Epidural Analgesia (TEA).
- ASA I-III
- Proficiency in Dutch to allow self-assessment via VAS-Anxiety
Key exclusion criteria (5 listed)
- Patient has history of Epilepsy or Seizure Disorder
- Regular use of anxiolytics, sedatives, or psychoactive medication at home.
- Deafness or blindness preventing VR engagement or VAS self-assessment.
- Known contraindication to TEA (e.g., coagulopathy) or refusal of TEA.
- Urgent or emergency surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR- headsetChildren will wear a VR headset during the placement of the epidural catheter. | Device | Interventional group |
Primary outcome
Postprocedural anxiety score
Time frame: postprocedural until 10 min after procedure
Subjective Anxiety/stress measured by the VAS from 0 (no anxiety/distress) and 100mm (extreme anxiety/distress)
6 secondary outcomes
anxiety assessments by the physician performing the epidural, the assisting nurse and accompanying parent, reflecting their perception of the patient's anxiety (NRS)
Time frame: 10 min preprocedural
anxiety questionnaire from the patient
Time frame: 10 min preprocedural
- Rescue sedation medication during placement of the epidural catheter
Time frame: during the procedure
- Efficacy of epidural placement:
Time frame: during the procedure
patient satisfaction score
Time frame: postprocedural until 10 min after procedure
- Pain score of placement of the epidural catheter
Time frame: postprocedural until 10 min after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Preoperative Anxiety Score
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Prediction of Postoperative Pain Using Venous Cannulation Pain and Preoperative Anxiety Scores
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Anesthesia Awareness on YouTube: Content and Quality Analysis
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Smartwatch Accuracy for Measuring Vitals and Anxiety Before Disc Surgery
Disc Herniations, Disc Herniation, Lumbar
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Effect of Emotional Freedom Technique on Surgical Fear and Vital Signs in Women Undergoing Cesarean Section
Cesarean Section, Preoperative Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing VR- headset in people with Preoperative Anxiety Score, run by Universitaire Ziekenhuizen KU Leuven.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Geertrui Dewinter, Phd, MD (+32 16 34 4270, geertrui.dewinter@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprocedural anxiety score (time frame: postprocedural until 10 min after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.