Pectus ExcavatumNCT06446518
Assessing Virtual Reality for Perioperative Anxiolysis in Adolescents Undergoing MIRPE Surgery
A study testing Virtual reality exposure in people with Pectus Excavatum and Pectus Deformity, run by Semmelweis University at 1 site in Hungary.
Trial summary
In this randomized control trial, investigators would like to assess as primary objective the effectiveness of VR in anxiolysis via using State Trait Anxiety- Inventory test various time during the perioperative period with recorded physiologic data. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pectus Excavatum, Pectus Deformity
- What is being tested?
- Virtual reality exposure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHungary
- Study dates
- 17 Aug 2022to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient between 13-18 years old
- reported chest deformity (pectus excavatum/ carinatum)
- patients undergoing MIRPE surgery in general anesthesia
- Hungarian fluency
- willing to comply with study procedures.
Who cannot join
- gross cognitive impairment that would interfere with the ability to consent or complete study procedures.
- Head injury
- Head infection
- Altered mental status (independently from midazolam)
- Scabies or louse
- Dizziness or vertigo
Show all 9Show fewer
- Blindness or severe vision loss
- Lack of parental/ guardian or patient consent
- Those, who has a head deformity, so VR headset does not fit well
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Paediatric Centre, Semmelweis University
Budapest, Budapest, 1083
About this study
Official title: A Randomized Control Trial for Assessing Virtual Reality for Perioperative Anxiolysis and Postoperative Pain Modulation in Adolescents Undergoing MIRPE Surgery
In this randomized control trial, investigators would like to assess as primary objective the effectiveness of VR in anxiolysis via using State Trait Anxiety- Inventory test various time during the perioperative period with recorded physiologic data. As a secondary objective they are investigating the use of VR in the postoperative period for pain modulation via using pain numeric rating scales (NRS), monitoring physiologic data, and collecting information on painkiller demand of the patients.
Read the detailed description
This prospective, randomized controlled trial will be conducted with participants from the Paediatric Center, Semmelweis University, a tertiary level health care centre based in Budapest, Hungary. We evaluate the effects of VR immersion on reducing perioperative anxiety and postoperative pain.
Participants will be asked to wear a VR headset for preferably an hour before and after the surgery. Patients will be asked to fill out three anxiety tests meanwhile investigators will record their vital parameters (HR, RR, SpO2, BP): on admission, in the operating room and on the surgical ward on the day after surgery. In the first postoperative day vital parameters, analgesic demand and NRS score will be recorded to follow patients pain status.
Researchers will compare VR group to control group to see if anxiety and pain was different among those who recieved the VR headset.
- Conditions
- Pectus Excavatum, Pectus Deformity
- Being tested
- Virtual reality exposure
- Medical subject headings
- Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality exposureDevice
Assessing immersive virtual reality as a distraction tool in anxiolysis and pain modulation.
| Study group | Role | What they receive |
|---|---|---|
| VR intervention group | Experimental | On admission, patients are asked to fill out a STAI-T and-S anxiety inventory. Attending investigator will take vital parameters upon admission.
Patients are asked to use the VR headset a minimum of 1 hour before surgery. Participants are asked to fill out a STAI-S test in the operating room, where physiologic data is collected and timing and dose of medication administered. After surgery, during emergence physiologic data is collected, and attending anesthesiologist fills out the PAED score. Patients are encouraged to use the VR headset after surgery, any time when they feel comfortable.
Pain using an NRS scale, and vital parameters are monitored postoperative 1, 2, 3, 6, 12 hours (if patient is not sleeping) and in the morning following surgery at 6 and 9 am. A final STAI-S test is filled out by patients in the morning after surgery. Data regarding painkiller demand is collected after surgery. Receives: Device: Virtual reality exposure |
| Control group | No intervention | On admission, patients are asked to fill out a STAI-T and-S anxiety inventory. Attending investigator will take vital parameters upon admission. Participants are asked to fill out a STAI-S test in the operating room, where physiologic data is collected and timing and dose of medication administered. After surgery, during emergence physiologic data is collected, and attending anesthesiologist fills out the PAED score. Pain using an NRS scale, and vital parameters are monitored postoperative 1, 2, 3, 6, 12 hours (if patient is not sleeping) and in the morning following surgery at 6 and 9 am. A final STAI-S test is filled out by patients in the morning after surgery. Data regarding painkiller demand is collected after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety
Anxiety assessed by STAI-S and STAI-T questionnaires level of anxiety will be assessed using the State Trait Anxiety-Inventory. The test is composed of 2 parts: STAI-S (How does the patient feel right now?) and STAI-T (How does the patient feel on average?). Both questionnaires contain 20 questions with answers rating from 1 to 4.
Measured: 1-2 days
Secondary outcomes (1)
Change in pain and vital parameters
Pain assessed by Numerical Pain Rating Scale level of pain will be assessed using the Numerical Pain Rating Scale. The scale is composed of 0 (no pain) to 10 (worst pain imaginable).
Vital parameters that are monitored during the study are blood pressure, heart rate, peripheral oxygen saturation and respiratory rate.
Pain will also be followed with analgesic demand per patien during the first postoperative day.
Measured: 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start17 Aug 2022
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pectus ExcavatumStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- Új Nemzeti Kiválóság Program
- Responsible party
- Principal investigator, Agnes Jermendy MD PhD MPH, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446518
- Sponsor's protocol ID
- NRG 2022/2
- Status last verified
- Jul 2025
- First submitted
- 31 May 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All relevant variables, that was collected during the study period will be shared after deidentifying the data.
Publications
Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013.
PubMed 10320165Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.
PubMed 8953995Klassen JA, Liang Y, Tjosvold L, Klassen TP, Hartling L. Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials. Ambul Pediatr. 2008 Mar-Apr;8(2):117-28. doi: 10.1016/j.ambp.2007.12.005.
PubMed 18355741Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.
PubMed 31136330Esposito C, Autorino G, Iervolino A, Vozzella EA, Cerulo M, Esposito G, Coppola V, Carulli R, Cortese G, Gallo L, Escolino M. Efficacy of a Virtual Reality Program in Pediatric Surgery to Reduce Anxiety and Distress Symptoms in the Preoperative Phase: A Prospective Randomized Clinical Trial. J Laparoendosc Adv Surg Tech A. 2022 Feb;32(2):197-203. doi: 10.1089/lap.2021.0566. Epub 2021 Dec 28.
PubMed 34962159Buyuk ET, Odabasoglu E, Uzsen H, Koyun M. The effect of virtual reality on Children's anxiety, fear, and pain levels before circumcision. J Pediatr Urol. 2021 Aug;17(4):567.e1-567.e8. doi: 10.1016/j.jpurol.2021.04.008. Epub 2021 Apr 21.
PubMed 34006462Jung MJ, Libaw JS, Ma K, Whitlock EL, Feiner JR, Sinskey JL. Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial. Anesth Analg. 2021 Mar 1;132(3):798-806. doi: 10.1213/ANE.0000000000005004.
PubMed 32618627Rumsey N, Harcourt D. Body image and disfigurement: issues and interventions. Body Image. 2004 Jan;1(1):83-97. doi: 10.1016/S1740-1445(03)00005-6.
PubMed 18089143Casatori L, Pellegrino A, Messineo A, Ghionzoli M, Facchini F, Modesti A, Modesti PA. Differential Influence of Physical Activity on Cardiopulmonary Performance and Stroke Volume Assessed at Cardiopulmonary Exercise Test in Pectus Excavatum: A Pilot Study. Front Physiol. 2022 Feb 3;13:831504. doi: 10.3389/fphys.2022.831504. eCollection 2022.
PubMed 35185624Trinh SH, Papai J, Kis-Tamas M, Csillag J, Czeh L, Tovishazi G, Petroczy A, Gobl G, Kalman A, Hauser B, Jermendy A. A randomized control trial for assessing virtual reality for perioperative anxiolysis and postoperative pain modulation in adolescents undergoing MIRPE. J Pediatr Surg. 2026 Jun;61(6):163042. doi: 10.1016/j.jpedsurg.2026.163042. Epub 2026 Feb 26.
PubMed 41763294
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial for Assessing Virtual Reality for Perioperative Anxiolysis and Postoperative Pain Modulation in Adolescents Undergoing MIRPE Surgery
- ClinicalTrials.gov ID
- NCT06446518
- Acronym / sponsor ID
- NRG 2022/2
- Conditions
- Pectus Excavatum, Pectus Deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- Új Nemzeti Kiválóság Program
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 6 Jun 2024 (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.
In this randomized control trial, investigators would like to assess as primary objective the effectiveness of VR in anxiolysis via using State Trait Anxiety- Inventory test various time during the perioperative period with recorded physiologic data. As a secondary objective they are investigating the use of VR in the postoperative period for pain modulation via using pain numeric rating scales (NRS), monitoring physiologic data, and collecting information on painkiller demand of the patients.
Detailed description
This prospective, randomized controlled trial will be conducted with participants from the Paediatric Center, Semmelweis University, a tertiary level health care centre based in Budapest, Hungary. We evaluate the effects of VR immersion on reducing perioperative anxiety and postoperative pain.
Participants will be asked to wear a VR headset for preferably an hour before and after the surgery. Patients will be asked to fill out three anxiety tests meanwhile investigators will record their vital parameters (HR, RR, SpO2, BP): on admission, in the operating room and on the surgical ward on the day after surgery. In the first postoperative day vital parameters, analgesic demand and NRS score will be recorded to follow patients pain status.
Researchers will compare VR group to control group to see if anxiety and pain was different among those who recieved the VR headset.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR intervention group | Experimental | Device: Virtual reality exposureOn admission, patients are asked to fill out a STAI-T and-S anxiety inventory. Attending investigator will take vital parameters upon admission. Patients are asked to use the VR headset a minimum of 1 hour before surgery. Participants are asked to fill out a STAI-S test in the operating room, where physiologic data is collected and timing and dose of medication administered. After surgery, during emergence physiologic data is collected, and attending anesthesiologist fills out the PAED score. Patients are encouraged to use the VR headset after surgery, any time when they feel comfortable. Pain using an NRS scale, and vital parameters are monitored postoperative 1, 2, 3, 6, 12 hours (if patient is not sleeping) and in the morning following surgery at 6 and 9 am. A final STAI-S test is filled out by patients in the morning after surgery. Data regarding painkiller demand is collected after surgery. |
| Control group | No intervention | –On admission, patients are asked to fill out a STAI-T and-S anxiety inventory. Attending investigator will take vital parameters upon admission. Participants are asked to fill out a STAI-S test in the operating room, where physiologic data is collected and timing and dose of medication administered. After surgery, during emergence physiologic data is collected, and attending anesthesiologist fills out the PAED score. Pain using an NRS scale, and vital parameters are monitored postoperative 1, 2, 3, 6, 12 hours (if patient is not sleeping) and in the morning following surgery at 6 and 9 am. A final STAI-S test is filled out by patients in the morning after surgery. Data regarding painkiller demand is collected after surgery. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patient between 13-18 years old
- reported chest deformity (pectus excavatum/ carinatum)
- patients undergoing MIRPE surgery in general anesthesia
- Hungarian fluency
- willing to comply with study procedures.
Key exclusion criteria (9 listed)
- gross cognitive impairment that would interfere with the ability to consent or complete study procedures.
- Head injury
- Head infection
- Altered mental status (independently from midazolam)
- Scabies or louse
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 |
|---|---|---|
| Virtual reality exposureAssessing immersive virtual reality as a distraction tool in anxiolysis and pain modulation. | Device | VR intervention group |
Primary outcome
Change in anxiety
Time frame: 1-2 days
Anxiety assessed by STAI-S and STAI-T questionnaires level of anxiety will be assessed using the State Trait Anxiety-Inventory. The test is composed of 2 parts: STAI-S (How does the patient feel right now?) and STAI-T (How does the patient feel on average?). Both questionnaires contain 20 questions with answers rating from 1 to 4.
1 secondary outcome
Change in pain and vital parameters
Time frame: 1-2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 10320165Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013.
- Background: PubMed 8953995Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.
- Background: PubMed 18355741Klassen JA, Liang Y, Tjosvold L, Klassen TP, Hartling L. Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials. Ambul Pediatr. 2008 Mar-Apr;8(2):117-28. doi: 10.1016/j.ambp.2007.12.005.
- Background: PubMed 31136330Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.
- Background: PubMed 34962159Esposito C, Autorino G, Iervolino A, Vozzella EA, Cerulo M, Esposito G, Coppola V, Carulli R, Cortese G, Gallo L, Escolino M. Efficacy of a Virtual Reality Program in Pediatric Surgery to Reduce Anxiety and Distress Symptoms in the Preoperative Phase: A Prospective Randomized Clinical Trial. J Laparoendosc Adv Surg Tech A. 2022 Feb;32(2):197-203. doi: 10.1089/lap.2021.0566. Epub 2021 Dec 28.
- Background: PubMed 34006462Buyuk ET, Odabasoglu E, Uzsen H, Koyun M. The effect of virtual reality on Children's anxiety, fear, and pain levels before circumcision. J Pediatr Urol. 2021 Aug;17(4):567.e1-567.e8. doi: 10.1016/j.jpurol.2021.04.008. Epub 2021 Apr 21.
- Background: PubMed 32618627Jung MJ, Libaw JS, Ma K, Whitlock EL, Feiner JR, Sinskey JL. Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial. Anesth Analg. 2021 Mar 1;132(3):798-806. doi: 10.1213/ANE.0000000000005004.
- Background: PubMed 18089143Rumsey N, Harcourt D. Body image and disfigurement: issues and interventions. Body Image. 2004 Jan;1(1):83-97. doi: 10.1016/S1740-1445(03)00005-6.
- Background: PubMed 35185624Casatori L, Pellegrino A, Messineo A, Ghionzoli M, Facchini F, Modesti A, Modesti PA. Differential Influence of Physical Activity on Cardiopulmonary Performance and Stroke Volume Assessed at Cardiopulmonary Exercise Test in Pectus Excavatum: A Pilot Study. Front Physiol. 2022 Feb 3;13:831504. doi: 10.3389/fphys.2022.831504. eCollection 2022.
- Derived from this study: PubMed 41763294Trinh SH, Papai J, Kis-Tamas M, Csillag J, Czeh L, Tovishazi G, Petroczy A, Gobl G, Kalman A, Hauser B, Jermendy A. A randomized control trial for assessing virtual reality for perioperative anxiolysis and postoperative pain modulation in adolescents undergoing MIRPE. J Pediatr Surg. 2026 Jun;61(6):163042. doi: 10.1016/j.jpedsurg.2026.163042. Epub 2026 Feb 26.
- Individual participant dataSharing planned: Yes. All relevant variables, that was collected during the study period will be shared after deidentifying the data.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality exposure in people with Pectus Excavatum and Pectus Deformity, run by Semmelweis University at 1 site in Hungary.
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 9 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: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety (time frame: 1-2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06446518, which also lists 10 linked publications.
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 8 Sep 2025.