Preoperative AnxietyNCT05094141
Comparing Virtual Reality (VR) to Non-VR for Decreasing Preoperative/Procedural Anxiety
A study testing Virtual reality in people with Preoperative Anxiety, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The primary objective of the study is to utilize the modified Yale Preoperative Anxiety scale (mYPAS), a validated preoperative/procedural anxiety score, to measure preoperative anxiety via distraction in pediatric oncology patients undergoing port access. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2021to 14 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any patient of the Children's Medical Center CCBD
- 5-12 years of age
- Patient requiring their port accessed twice or more within a 6 months period
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Subjects younger than 5 and older than 12
- Patients requiring recovery in PICU or sites other than PACU
- If parents or subject is not willing to participate
- Subjects with severe developmental delays and subjects with developmental challenges preventing them from keeping the VR device on are also excluded
- Patients who will not be in CCBD for port access at least twice in 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Pilot Crossover Study Comparing Virtual Reality (VR) and Non-VR Distraction for Decreasing Preoperative/Procedural Anxiety as a Function of the Modified Yale Preoperative Anxiety Scale (mYPAS)
The primary objective of the study is to utilize the modified Yale Preoperative Anxiety scale (mYPAS), a validated preoperative/procedural anxiety score, to measure preoperative anxiety via distraction in pediatric oncology patients undergoing port access.
The hypothesis is that using Virtual Reality (VR) will objectively decrease anxiety scores measured by mYPAS by five percent (primary outcome).
Read more
The secondary outcome will be the parents or the legally authorized representative (LAR) subjective reports of anxiety with the use of VR.
The Kind VR device is used in house at Children's Health in the Dallas and Plano campuses. The VR device used in this study qualifies as exempt from FDA IDE regulations. It is a non-significant risk, non-invasive, interactive video device the user wears like goggles. The study carries minimal risks to the subjects and is designed to minimize patient discomfort from placement or motion sickness. Furthermore, the device has disposable covers for protection against infection and can be sanitized between uses, once the disposable covers are removed. Children's Health System of Texas (CHST) and this research group are not partnering entities with the Kind VR, and the Kind VR device is not being studied. The effect of virtual reality (VR) on preprocedural anxiety as measured by questionnaires and the observations of the modified Yale Preoperative Anxiety Scale (mYPAS) is being studied
Most patients coming to the Clinic of Cancer and Blood Disorders (CCBD) are under chronic care for their ongoing disease and are likely to be coming to the CCBD at least twice in a 6-month period. The CCBD schedule will be reviewed by the researchers for patients age 5-12, requiring port access at least twice during the next six-month period. Patient families whose child meets the basic screening criteria, and have no exclusion criteria, will be approached privately as possible participants in the study. Up to 100 subjects will be enrolled over a 2-year period. Once the subject/parent or LAR agrees to participate, study staff will randomize the subjects into which standard of care distraction method for anxiety management they will receive first in this study.
Read the detailed description
- After the potential participants signed informed consent and were screened for the ability to participate in the study at a treatment appointment.
- They then came to their cancer center (CCBD) appointment for port access for chemotherapy and were randomized to the Virtual Reality (VR) distraction group first, OR the Non-Virtual Reality (Non-VR) Distraction group first.
- At this CCBD visit, they then participated in their port needle access as part of standard of care for their cancer treatment using either VR or non-VR distraction for anxiety mitigation, depending on randomization, and were observed during the needle access with the Modified Yale Pre-procedural Anxiety Scale (mYPAS) to assess anxiety during the needle access procedure. The mYPAS is an objective, validated, observational anxiety assessment tool.
- In addition, parents were asked subjective questions as to how they thought their child tolerated Port needle access with the VR versus Non-VR accordingly.
- The study personnel then asked when their next potential cancer center appointment for port access to schedule participation in the second arm according to their randomization stratification. In this way, each study participant served as their own control.
- At the next possible port needle access appointment, they were once again observed using the mYPAS scale for the 2nd port access, with either VR or Non-VR distraction, depending on initial randomization group.
- Parents were once again asked subjective questions as to how they thought their child tolerated Port needle access with the VR versus Non-VR accordingly.
- The participants data could Only be included in the study if they participated in both study arms to completion.
- Conditions
- Preoperative Anxiety
- Being tested
- Virtual reality
- Keywords
- virtual reality, preoperative anxiety, modified Yale Preoperative Anxiety Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
Also called Kind VR game
Virtual reality game played during port needle access.
| Study group | Role | What they receive |
|---|---|---|
| Non-VR (Virtual reality) | No intervention | The patient is not assigned to play the VR game. mYPAS scoring for port access is done. |
| VR (Virtual Reality) | Experimental | The patient is assigned to play the VR game for 15 minutes prior to actual port access procedure start. mYPAS scoring while playing VR device for Port access Receives: Other: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety Score in Pediatric Oncology Patients
Preoperative anxiety score in pediatric oncology patients as measured by modified Yale Preoperative Anxiety Scale (mYPAS), a validated preoperative/procedural anxiety score.
Possible scores range from 23 to 100. Higher score values are correlated with increased preoperative anxiety.
Measured: 2 years
Secondary outcomes (1)
Number of Parents or Legally Authorized Representative (LAR) Who Subjectively Report Decreased Anxiety With the Use of VR
Number of parents or legally authorized representative (LAR) who subjectively report decreased anxiety in their kids (participants in this study) with the use of VR (Virtual Reality) would be calculated based on Parents' questionnaires scored and evaluated for subjective improvement in parental assessment of preoperative anxiety.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start13 Jan 2021
- Primary completion14 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Preoperative AnxietyStudies 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
- Crossover
- Model description
- Randomized Crossover design study will be performed. Subjects will be randomized (1 to 1 randomization) at their initial encounter to either VR or Non-VR. During their second visit patients will be given the alternative mode of care (i.e. patients who initially received VR distraction will be given Non-VR distraction, and patients who initially received Non- VR distraction will receive VR distraction)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah E Rebstock, University of Texas Southwestern Medical Center
- Investigators
- Sarah Rebstock, MD, Principal investigator, UT SouthwesternNeethu Chandran, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094141
- Sponsor's protocol ID
- STU-2020-0607
- Status last verified
- Jul 2025
- First submitted
- 22 Oct 2021
- Last updated
- 11 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fronk E, Billick SB. Pre-operative Anxiety in Pediatric Surgery Patients: Multiple Case Study Analysis with Literature Review. Psychiatr Q. 2020 Dec;91(4):1439-1451. doi: 10.1007/s11126-020-09780-z.
PubMed 32424544Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
PubMed 16882820Myers RM, Balsamo L, Lu X, Devidas M, Hunger SP, Carroll WL, Winick NJ, Maloney KW, Kadan-Lottick NS. A prospective study of anxiety, depression, and behavioral changes in the first year after a diagnosis of childhood acute lymphoblastic leukemia: a report from the Children's Oncology Group. Cancer. 2014 May 1;120(9):1417-25. doi: 10.1002/cncr.28578. Epub 2014 Jan 28.
PubMed 24473774Pelcovitz D, Libov BG, Mandel F, Kaplan S, Weinblatt M, Septimus A. Posttraumatic stress disorder and family functioning in adolescent cancer. J Trauma Stress. 1998 Apr;11(2):205-21. doi: 10.1023/A:1024442802113.
PubMed 9565912Wu Y, Chen J, Ma W, Guo L, Feng H. Virtual reality in preoperative preparation of children undergoing general anesthesia: a randomized controlled study. Anaesthesiologie. 2022 Dec;71(Suppl 2):204-211. doi: 10.1007/s00101-022-01177-w. Epub 2022 Aug 1.
PubMed 35925196Agbayani CG, Fortier MA, Kain ZN. Non-pharmacological methods of reducing perioperative anxiety in children. BJA Educ. 2020 Dec;20(12):424-430. doi: 10.1016/j.bjae.2020.08.003. Epub 2020 Oct 21. No abstract available.
PubMed 33456927Chiu PL, Li H, Yap KY, Lam KC, Yip PR, Wong CL. Virtual Reality-Based Intervention to Reduce Preoperative Anxiety in Adults Undergoing Elective Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2340588. doi: 10.1001/jamanetworkopen.2023.40588.
PubMed 37906193Xu H, Hou J, Zhou J, Wang S. Effects of Virtual Reality on Preoperative Anxiety in Adult Patients: An Updated Meta-analysis. J Perianesth Nurs. 2025 Apr;40(2):422-430.e3. doi: 10.1016/j.jopan.2024.05.009. Epub 2024 Sep 26.
PubMed 39340515Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
PubMed 9322455Mai CL, Burns S, August DA, Bhattacharya ST, Mueller A, Houle TT, Anderson TA, Peck J. Cardiac index as a surrogate marker for anxiety in pediatric patients undergoing ambulatory endoscopy: a prospective cohort study. Physiol Meas. 2024 Oct 9;45(10). doi: 10.1088/1361-6579/ad805e.
PubMed 39326507Hu L, Hua Y, Wang L, Mao Z, Jia X, Lei Z, Chang D, Cheng W. Effect of Short-term Deep Breathing Exercises on Perioperative Anxiety and Pain in Pediatric Orthopedic Patients: A Randomized Controlled Trial. J Perianesth Nurs. 2025 Feb;40(1):69-75. doi: 10.1016/j.jopan.2024.03.009. Epub 2024 Jul 9.
PubMed 38980240Thung A, Tumin D, Uffman JC, Tobias JD, Buskirk T, Garrett W, Karczewski A, Saadat H. The Utility of the Modified Yale Preoperative Anxiety Scale for Predicting Success in Pediatric Patients Undergoing MRI Without the Use of Anesthesia. J Am Coll Radiol. 2018 Sep;15(9):1232-1237. doi: 10.1016/j.jacr.2017.12.022. Epub 2018 Mar 2.
PubMed 29483054Desai B, Newcomb N, Plost B, Waldron S, Sarkar K, Haber L. Virtual reality use in pediatric patients for orthopedic clinical procedures: A randomized prospective trial of efficacy. J Child Orthop. 2024 May 26;18(4):414-420. doi: 10.1177/18632521241254707. eCollection 2024 Aug.
PubMed 39100983Chan EA, Chung JW, Wong TK, Lien AS, Yang JY. Application of a virtual reality prototype for pain relief of pediatric burn in Taiwan. J Clin Nurs. 2007 Apr;16(4):786-93. doi: 10.1111/j.1365-2702.2006.01719.x.
PubMed 17402961Smith KL, Wang Y, Colloca L. Impact of Virtual Reality Technology on Pain and Anxiety in Pediatric Burn Patients: A Systematic Review and Meta-Analysis. Front Virtual Real. 2022 Jan;2:751735. doi: 10.3389/frvir.2021.751735. Epub 2022 Jan 6.
PubMed 36247202
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Crossover Study Comparing Virtual Reality (VR) and Non-VR Distraction for Decreasing Preoperative/Procedural Anxiety as a Function of the Modified Yale Preoperative Anxiety Scale (mYPAS)
- ClinicalTrials.gov ID
- NCT05094141
- Acronym / sponsor ID
- STU-2020-0607
- Conditions
- Preoperative Anxiety
- Keywords
- virtual reality, preoperative anxiety, modified Yale Preoperative Anxiety Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Posted 11 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to utilize the modified Yale Preoperative Anxiety scale (mYPAS), a validated preoperative/procedural anxiety score, to measure preoperative anxiety via distraction in pediatric oncology patients undergoing port access.
The hypothesis is that using Virtual Reality (VR) will objectively decrease anxiety scores measured by mYPAS by five percent (primary outcome).
The secondary outcome will be the parents or the legally authorized representative (LAR) subjective reports of anxiety with the use of VR.
The Kind VR device is used in house at Children's Health in the Dallas and Plano campuses. The VR device used in this study qualifies as exempt from FDA IDE regulations. It is a non-significant risk, non-invasive, interactive video device the user wears like goggles. The study carries minimal risks to the subjects and is designed to minimize patient discomfort from placement or motion sickness. Furthermore, the device has disposable covers for protection against infection and can be sanitized between uses, once the disposable covers are removed. Children's Health System of Texas (CHST) and this research group are not partnering entities with the Kind VR, and the Kind VR device is not being studied. The effect of virtual reality (VR) on preprocedural anxiety as measured by questionnaires and the observations of the modified Yale Preoperative Anxiety Scale (mYPAS) is being studied
Most patients coming to the Clinic of Cancer and Blood Disorders (CCBD) are under chronic care for their ongoing disease and are likely to be coming to the CCBD at least twice in a 6-month period. The CCBD schedule will be reviewed by the researchers for patients age 5-12, requiring port access at least twice during the next six-month period. Patient families whose child meets the basic screening criteria, and have no exclusion criteria, will be approached privately as possible participants in the study. Up to 100 subjects will be enrolled over a 2-year period. Once the subject/parent or LAR agrees to participate, study staff will randomize the subjects into which standard of care distraction method for anxiety management they will receive first in this study.
Detailed description
- After the potential participants signed informed consent and were screened for the ability to participate in the study at a treatment appointment.
- They then came to their cancer center (CCBD) appointment for port access for chemotherapy and were randomized to the Virtual Reality (VR) distraction group first, OR the Non-Virtual Reality (Non-VR) Distraction group first.
- At this CCBD visit, they then participated in their port needle access as part of standard of care for their cancer treatment using either VR or non-VR distraction for anxiety mitigation, depending on randomization, and were observed during the needle access with the Modified Yale Pre-procedural Anxiety Scale (mYPAS) to assess anxiety during the needle access procedure. The mYPAS is an objective, validated, observational anxiety assessment tool.
- In addition, parents were asked subjective questions as to how they thought their child tolerated Port needle access with the VR versus Non-VR accordingly.
- The study personnel then asked when their next potential cancer center appointment for port access to schedule participation in the second arm according to their randomization stratification. In this way, each study participant served as their own control.
- At the next possible port needle access appointment, they were once again observed using the mYPAS scale for the 2nd port access, with either VR or Non-VR distraction, depending on initial randomization group.
- Parents were once again asked subjective questions as to how they thought their child tolerated Port needle access with the VR versus Non-VR accordingly.
- The participants data could Only be included in the study if they participated in both study arms to completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Crossover design study will be performed. Subjects will be randomized (1 to 1 randomization) at their initial encounter to either VR or Non-VR. During their second visit patients will be given the alternative mode of care (i.e. patients who initially received VR distraction will be given Non-VR distraction, and patients who initially received Non- VR distraction will receive VR distraction)
| Arm | Type | Receives |
|---|---|---|
| Non-VR (Virtual reality) | No intervention | –The patient is not assigned to play the VR game. mYPAS scoring for port access is done. |
| VR (Virtual Reality) | Experimental | Other: Virtual realityThe patient is assigned to play the VR game for 15 minutes prior to actual port access procedure start. mYPAS scoring while playing VR device for Port access |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Any patient of the Children's Medical Center CCBD
- 5-12 years of age
- Patient requiring their port accessed twice or more within a 6 months period
- Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (5 listed)
- Subjects younger than 5 and older than 12
- Patients requiring recovery in PICU or sites other than PACU
- If parents or subject is not willing to participate
- Subjects with severe developmental delays and subjects with developmental challenges preventing them from keeping the VR device on are also excluded
- Patients who will not be in CCBD for port access at least twice in 6 months
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 realityAlso: Kind VR gameVirtual reality game played during port needle access. | Other | VR (Virtual Reality) |
Primary outcome
Preoperative Anxiety Score in Pediatric Oncology Patients
Time frame: 2 years
Preoperative anxiety score in pediatric oncology patients as measured by modified Yale Preoperative Anxiety Scale (mYPAS), a validated preoperative/procedural anxiety score. Possible scores range from 23 to 100. Higher score values are correlated with increased preoperative anxiety.
1 secondary outcome
Number of Parents or Legally Authorized Representative (LAR) Who Subjectively Report Decreased Anxiety With the Use of VR
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32424544Fronk E, Billick SB. Pre-operative Anxiety in Pediatric Surgery Patients: Multiple Case Study Analysis with Literature Review. Psychiatr Q. 2020 Dec;91(4):1439-1451. doi: 10.1007/s11126-020-09780-z.
- Background: PubMed 16882820Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
- Background: PubMed 24473774Myers RM, Balsamo L, Lu X, Devidas M, Hunger SP, Carroll WL, Winick NJ, Maloney KW, Kadan-Lottick NS. A prospective study of anxiety, depression, and behavioral changes in the first year after a diagnosis of childhood acute lymphoblastic leukemia: a report from the Children's Oncology Group. Cancer. 2014 May 1;120(9):1417-25. doi: 10.1002/cncr.28578. Epub 2014 Jan 28.
- Background: PubMed 9565912Pelcovitz D, Libov BG, Mandel F, Kaplan S, Weinblatt M, Septimus A. Posttraumatic stress disorder and family functioning in adolescent cancer. J Trauma Stress. 1998 Apr;11(2):205-21. doi: 10.1023/A:1024442802113.
- Background: PubMed 35925196Wu Y, Chen J, Ma W, Guo L, Feng H. Virtual reality in preoperative preparation of children undergoing general anesthesia: a randomized controlled study. Anaesthesiologie. 2022 Dec;71(Suppl 2):204-211. doi: 10.1007/s00101-022-01177-w. Epub 2022 Aug 1.
- Background: PubMed 33456927Agbayani CG, Fortier MA, Kain ZN. Non-pharmacological methods of reducing perioperative anxiety in children. BJA Educ. 2020 Dec;20(12):424-430. doi: 10.1016/j.bjae.2020.08.003. Epub 2020 Oct 21. No abstract available.
- Background: PubMed 37906193Chiu PL, Li H, Yap KY, Lam KC, Yip PR, Wong CL. Virtual Reality-Based Intervention to Reduce Preoperative Anxiety in Adults Undergoing Elective Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2340588. doi: 10.1001/jamanetworkopen.2023.40588.
- Background: PubMed 39340515Xu H, Hou J, Zhou J, Wang S. Effects of Virtual Reality on Preoperative Anxiety in Adult Patients: An Updated Meta-analysis. J Perianesth Nurs. 2025 Apr;40(2):422-430.e3. doi: 10.1016/j.jopan.2024.05.009. Epub 2024 Sep 26.
- Background: PubMed 9322455Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
- Background: PubMed 39326507Mai CL, Burns S, August DA, Bhattacharya ST, Mueller A, Houle TT, Anderson TA, Peck J. Cardiac index as a surrogate marker for anxiety in pediatric patients undergoing ambulatory endoscopy: a prospective cohort study. Physiol Meas. 2024 Oct 9;45(10). doi: 10.1088/1361-6579/ad805e.
- Background: PubMed 38980240Hu L, Hua Y, Wang L, Mao Z, Jia X, Lei Z, Chang D, Cheng W. Effect of Short-term Deep Breathing Exercises on Perioperative Anxiety and Pain in Pediatric Orthopedic Patients: A Randomized Controlled Trial. J Perianesth Nurs. 2025 Feb;40(1):69-75. doi: 10.1016/j.jopan.2024.03.009. Epub 2024 Jul 9.
- Background: PubMed 29483054Thung A, Tumin D, Uffman JC, Tobias JD, Buskirk T, Garrett W, Karczewski A, Saadat H. The Utility of the Modified Yale Preoperative Anxiety Scale for Predicting Success in Pediatric Patients Undergoing MRI Without the Use of Anesthesia. J Am Coll Radiol. 2018 Sep;15(9):1232-1237. doi: 10.1016/j.jacr.2017.12.022. Epub 2018 Mar 2.
- Individual participant dataSharing planned: No
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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.
Sarah Rebstock, MD principal investigator
UT Southwestern
Neethu Chandran principal investigator
UT Southwestern
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 in people with Preoperative Anxiety, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 11 Jul 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Preoperative Anxiety Score in Pediatric Oncology Patients (time frame: 2 years). 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 NCT05094141, which also lists 17 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 11 Jul 2025.