Preoperative AnxietyNCT07650695
Virtual Reality for Pediatric Perioperative Preparation
A study testing NixiKit Virtual Reality Preparation and Standard Nursing Preoperative Preparation in people with Preoperative Anxiety and Fear, run by Fundación de investigación HM at 1 site in Spain.
Trial summary
This pilot randomized controlled trial will evaluate whether a virtual reality (VR) preparation program can improve the perioperative experience of children aged 3 to 12 years undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Preoperative Anxiety, Fear, Pediatric Surgery
- What is being tested?
- NixiKit Virtual Reality Preparation and Standard Nursing Preoperative Preparation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 9 Sep 2026to 1 Apr 2027
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 12 years.
- Scheduled for elective surgery under anesthesia.
- Parent or legal guardian owns a mobile phone.
- Ability to understand simple instructions, according to clinical judgment and developmental level.
- Sufficient Spanish language proficiency of the child and at least one parent or legal guardian.
- Written informed consent from parents or legal guardians and child assent when applicable.
Who cannot join
- Emergency or urgent surgery.
- Moderate to severe neurodevelopmental disorder or intellectual disability limiting understanding of the intervention or study scales.
- Severe visual or hearing impairment preventing use of virtual reality.
- History of photosensitive epilepsy, severe vertigo, severe motion sickness, or other conditions that could worsen with virtual reality.
- Severe decompensated psychiatric disorder.
- Use of intense sedative premedication before baseline assessment that prevents evaluation of preoperative anxiety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital HM Puerta del Sur
Madrid, Mujer, 28229
Cayetana Ruiz Zaldibar, PhD, 695829472, crzaldibar@ucjc.edu
About this study
Official title: Preoperative Virtual Reality Intervention to Improve the Perioperative Experience in Children Undergoing Elective Surgery: A Pilot Randomized Controlled Trial
This pilot randomized controlled trial will evaluate whether a virtual reality (VR) preparation program can improve the perioperative experience of children aged 3 to 12 years undergoing elective surgery. Children scheduled for surgery at HM Hospital in Madrid, Spain, will be randomly assigned to receive either a VR-based educational experience (NixiKit) or the standard preoperative preparation routinely provided by nursing staff.
The VR intervention includes an immersive virtual tour of the preoperative area, operating room, and recovery room, designed to familiarize children with the surgical process in an age-appropriate manner. The control group will receive the usual verbal explanation and support provided by nurses before surgery.
The study will assess children's fear, preoperative anxiety, cooperation during anesthesia induction, and postoperative pain. Parents' experience and satisfaction with care will also be evaluated. The results of this pilot study will help determine the feasibility and potential effectiveness of VR as a nursing-led preparation strategy for pediatric surgical patients.
Read the detailed description
Preoperative anxiety and fear are common among children undergoing elective surgery and may negatively affect cooperation during anesthesia induction, perioperative experience, and postoperative recovery. Educational preparation programs have been developed to help children and their families better understand the surgical process; however, conventional preparation methods may not fully address the emotional needs of pediatric patients.
Virtual reality (VR) has emerged as a promising tool for perioperative preparation by providing immersive and interactive experiences that allow children to become familiar with the hospital environment before surgery. Previous randomized studies and recent systematic reviews have suggested that VR-based preparation may reduce preoperative anxiety and fear while improving cooperation during anesthesia induction and family satisfaction. Nevertheless, evidence remains limited regarding its effectiveness when compared with structured nurse-led preparation delivered as part of routine clinical practice, particularly in real-world hospital settings.
This pilot study aims to evaluate the feasibility and potential effectiveness of a VR-based preoperative preparation program for pediatric patients undergoing elective surgery. The intervention uses the NixiKit system, which provides an immersive virtual tour of the perioperative journey, including the preoperative area, operating room, and recovery room, through age-appropriate audiovisual content designed to familiarize children with the surgical environment.
Participants assigned to the intervention group will receive the VR experience during hospital admission before surgery. Participants assigned to the comparison group will receive the standard preoperative preparation routinely delivered by nursing staff. Data collected during the perioperative period will be used to explore the impact of the intervention on psychological and behavioral outcomes in children as well as on family experience.
As a pilot randomized controlled trial, this study is intended to provide preliminary estimates of intervention effects, assess study procedures and feasibility, and generate information to support the design of a future definitive multicenter trial evaluating virtual reality as a perioperative preparation strategy in pediatric surgical care.
- Conditions
- Preoperative Anxiety, Fear, Pediatric Surgery, Preoperative Care
- Being tested
- NixiKit Virtual Reality Preparation, Standard Nursing Preoperative Preparation
- Keywords
- Virtual Reality, Pediatric Surgery, Perioperative Care, children, Nursing intervention, fear, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NixiKit Virtual Reality PreparationDevice
Participants assigned to the intervention group will receive a virtual reality-based preoperative preparation program using the NixiKit system (Nixi for Children). The intervention consists of an immersive 360-degree virtual tour delivered through a pediatric virtual reality headset connected to a smartphone. The experience guides children through the perioperative journey, including the preoperative area, operating room, and recovery room, using age-appropriate narration and storytelling designed to familiarize them with the surgical environment and procedures. The virtual experience lasts approximately 10 to 15 minutes and is delivered during hospital admission before elective surgery. In addition to the virtual reality experience, participants receive the standard components of the NixiKit package, including educational and supportive materials intended to reinforce preparation for surgery.
Standard Nursing Preoperative PreparationBehavioural
Participants assigned to the control group will receive the standard preoperative preparation routinely provided by nursing staff. This preparation includes a verbal explanation of the perioperative process, including transfer to the preoperative area, operating room procedures, anesthesia induction, and postoperative recovery, as well as the opportunity for children and their parents to ask questions and receive clarification about the surgical process.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Preparation | Experimental | Participants assigned to this arm will receive a virtual reality-based preoperative preparation program using the NixiKit system before elective surgery. The intervention consists of an immersive 360-degree virtual tour of the perioperative pathway, including the preoperative area, operating room, and recovery room, delivered through a virtual reality headset connected to amobile phone. The experience is designed to familiarize children with the surgical environment, reduce fear and anxiety, and improve preparedness for surgery. Participants will also receive routine perioperative care provided by the hospital. Receives: Device: NixiKit Virtual Reality Preparation |
| Standard Nursing Preparation | Active comparator | Participants assigned to this arm will receive the standard preoperative preparation routinely provided by nursing staff before elective surgery. This preparation includes a verbal explanation of the perioperative process, including admission procedures, transfer to the preoperative area, anesthesia induction, the operating room environment, and postoperative recovery. Children and their parents will have the opportunity to ask questions and receive clarification regarding the surgical procedure. Participants will receive routine perioperative care according to hospital practice. Receives: Behavioral: Standard Nursing Preoperative Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Preoperative Anxiety
Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS), an observational instrument widely used in pediatric surgical populations. The scale evaluates activity, vocalization, emotional expressivity, apparent arousal, and interaction with parents. Total scores range from 23.3 to 100, with higher scores indicating greater anxiety. The primary outcome will be the change in mYPAS score between baseline assessment and post-intervention assessment.
Measured: From baseline (T0, immediately before intervention) to immediately after intervention (T1, approximately 15-45 minutes after baseline). Same day, prior to surgery
Change in Fear Level
Measured using the Children's Fear Scale (CFS). Scores range from 0 to 4, with higher scores indicating greater fear. The outcome will be the change in fear score from baseline to immediately after the intervention.
Measured: From baseline (T0, immediately before intervention) to immediately after intervention (T1, approximately 15-45 minutes after baseline). Same day, prior to surgery
Secondary outcomes (3)
Cooperation During Anesthesia Induction
Cooperation during anesthesia induction will be assessed using the Induction Compliance Checklist (ICC). The checklist includes 10 observational items scored as 0 or 1, with higher scores indicating more negative behaviors and poorer cooperation during induction.
Measured: During anesthesia induction, after transfer to the operating room on the day of surgery.
Postoperative Pain
Pain will be assessed using the Wong-Baker FACES Pain Rating Scale. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Measured: Day of surgery, after return to the hospital room
Parent Experience and Satisfaction
Parent experience and satisfaction will be assessed using the EMCA Pediatric Hospitalization Questionnaire, a parent-reported measure of pediatric inpatient experience. The questionnaire includes multiple items evaluating information provided, communication with healthcare professionals, participation in care, hospital environment, and overall quality of care. Individual questionnaire items will be analyzed according to their response categories, with more favorable responses indicating a more positive care experience.
Measured: At hospital discharge, up to 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start9 Sep 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel study arms. The intervention arm will receive a virtual reality-based preoperative preparation program (NixiKit) in addition to routine perioperative care, while the control arm will receive the standard preoperative preparation routinely provided by nursing staff. Participants will remain in their assigned group throughout the study, and outcomes will be assessed at predefined perioperative time points.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación de investigación HM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650695
- Sponsor's protocol ID
- 17_26_26.06.2733-GHM
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Franco Castanys T, Jimenez Carrion A, Rodenas Gomez F, Clemente Garcia S, Melero Mascaray A, Janeiro Amela M, Busquets Bonet J. Effects of virtual tour on perioperative pediatric anxiety. Paediatr Anaesth. 2023 May;33(5):377-386. doi: 10.1111/pan.14639. Epub 2023 Feb 7.
PubMed 36700361Jenkins BN, Fortier MA, Kaplan SH, Mayes LC, Kain ZN. Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg. 2014 Sep;119(3):643-650. doi: 10.1213/ANE.0000000000000350.
PubMed 25010821McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
PubMed 21806301
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Virtual Reality Intervention to Improve the Perioperative Experience in Children Undergoing Elective Surgery: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07650695
- Acronym / sponsor ID
- 17_26_26.06.2733-GHM
- Conditions
- Preoperative Anxiety, Fear, Pediatric Surgery, Preoperative Care
- Keywords
- Virtual Reality, Pediatric Surgery, Perioperative Care, children, Nursing intervention, fear, anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Fundación de investigación HMUniversity, hospital or other
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 16 Jun 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.
This pilot randomized controlled trial will evaluate whether a virtual reality (VR) preparation program can improve the perioperative experience of children aged 3 to 12 years undergoing elective surgery. Children scheduled for surgery at HM Hospital in Madrid, Spain, will be randomly assigned to receive either a VR-based educational experience (NixiKit) or the standard preoperative preparation routinely provided by nursing staff.
The VR intervention includes an immersive virtual tour of the preoperative area, operating room, and recovery room, designed to familiarize children with the surgical process in an age-appropriate manner. The control group will receive the usual verbal explanation and support provided by nurses before surgery.
The study will assess children's fear, preoperative anxiety, cooperation during anesthesia induction, and postoperative pain. Parents' experience and satisfaction with care will also be evaluated. The results of this pilot study will help determine the feasibility and potential effectiveness of VR as a nursing-led preparation strategy for pediatric surgical patients.
Detailed description
Preoperative anxiety and fear are common among children undergoing elective surgery and may negatively affect cooperation during anesthesia induction, perioperative experience, and postoperative recovery. Educational preparation programs have been developed to help children and their families better understand the surgical process; however, conventional preparation methods may not fully address the emotional needs of pediatric patients.
Virtual reality (VR) has emerged as a promising tool for perioperative preparation by providing immersive and interactive experiences that allow children to become familiar with the hospital environment before surgery. Previous randomized studies and recent systematic reviews have suggested that VR-based preparation may reduce preoperative anxiety and fear while improving cooperation during anesthesia induction and family satisfaction. Nevertheless, evidence remains limited regarding its effectiveness when compared with structured nurse-led preparation delivered as part of routine clinical practice, particularly in real-world hospital settings.
This pilot study aims to evaluate the feasibility and potential effectiveness of a VR-based preoperative preparation program for pediatric patients undergoing elective surgery. The intervention uses the NixiKit system, which provides an immersive virtual tour of the perioperative journey, including the preoperative area, operating room, and recovery room, through age-appropriate audiovisual content designed to familiarize children with the surgical environment.
Participants assigned to the intervention group will receive the VR experience during hospital admission before surgery. Participants assigned to the comparison group will receive the standard preoperative preparation routinely delivered by nursing staff. Data collected during the perioperative period will be used to explore the impact of the intervention on psychological and behavioral outcomes in children as well as on family experience.
As a pilot randomized controlled trial, this study is intended to provide preliminary estimates of intervention effects, assess study procedures and feasibility, and generate information to support the design of a future definitive multicenter trial evaluating virtual reality as a perioperative preparation strategy in pediatric surgical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel study arms. The intervention arm will receive a virtual reality-based preoperative preparation program (NixiKit) in addition to routine perioperative care, while the control arm will receive the standard preoperative preparation routinely provided by nursing staff. Participants will remain in their assigned group throughout the study, and outcomes will be assessed at predefined perioperative time points.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Preparation | Experimental | Device: NixiKit Virtual Reality PreparationParticipants assigned to this arm will receive a virtual reality-based preoperative preparation program using the NixiKit system before elective surgery. The intervention consists of an immersive 360-degree virtual tour of the perioperative pathway, including the preoperative area, operating room, and recovery room, delivered through a virtual reality headset connected to amobile phone. The experience is designed to familiarize children with the surgical environment, reduce fear and anxiety, and improve preparedness for surgery. Participants will also receive routine perioperative care provided by the hospital. |
| Standard Nursing Preparation | Active comparator | Behavioral: Standard Nursing Preoperative PreparationParticipants assigned to this arm will receive the standard preoperative preparation routinely provided by nursing staff before elective surgery. This preparation includes a verbal explanation of the perioperative process, including admission procedures, transfer to the preoperative area, anesthesia induction, the operating room environment, and postoperative recovery. Children and their parents will have the opportunity to ask questions and receive clarification regarding the surgical procedure. Participants will receive routine perioperative care according to hospital practice. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 3 to 12 years.
- Scheduled for elective surgery under anesthesia.
- Parent or legal guardian owns a mobile phone.
- Ability to understand simple instructions, according to clinical judgment and developmental level.
- Sufficient Spanish language proficiency of the child and at least one parent or legal guardian.
Key exclusion criteria (6 listed)
- Emergency or urgent surgery.
- Moderate to severe neurodevelopmental disorder or intellectual disability limiting understanding of the intervention or study scales.
- Severe visual or hearing impairment preventing use of virtual reality.
- History of photosensitive epilepsy, severe vertigo, severe motion sickness, or other conditions that could worsen with virtual reality.
- Severe decompensated psychiatric disorder.
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 |
|---|---|---|
| NixiKit Virtual Reality PreparationParticipants assigned to the intervention group will receive a virtual reality-based preoperative preparation program using the NixiKit system (Nixi for Children). The intervention consists of an immersive 360-degree virtual tour delivered through a pediatric virtual reality headset connected to a smartphone. The experience guides children through the perioperative journey, including the preoperative area, operating room, and recovery room, using age-appropriate narration and storytelling designed to familiarize them with the surgical environment and procedures. The virtual experience lasts approximately 10 to 15 minutes and is delivered during hospital admission before elective surgery. In addition to the virtual reality experience, participants receive the standard components of the NixiKit package, including educational and supportive materials intended to reinforce preparation for surgery. | Device | Virtual Reality Preparation |
| Standard Nursing Preoperative PreparationParticipants assigned to the control group will receive the standard preoperative preparation routinely provided by nursing staff. This preparation includes a verbal explanation of the perioperative process, including transfer to the preoperative area, operating room procedures, anesthesia induction, and postoperative recovery, as well as the opportunity for children and their parents to ask questions and receive clarification about the surgical process. | Behavioural | Standard Nursing Preparation |
Primary outcome
Change in Preoperative Anxiety
Time frame: From baseline (T0, immediately before intervention) to immediately after intervention (T1, approximately 15-45 minutes after baseline). Same day, prior to surgery
Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS), an observational instrument widely used in pediatric surgical populations. The scale evaluates activity, vocalization, emotional expressivity, apparent arousal, and interaction with parents. Total scores range from 23.3 to 100, with higher scores indicating greater anxiety. The primary outcome will be the change in mYPAS score between baseline assessment and post-intervention assessment.
Change in Fear Level
Time frame: From baseline (T0, immediately before intervention) to immediately after intervention (T1, approximately 15-45 minutes after baseline). Same day, prior to surgery
Measured using the Children's Fear Scale (CFS). Scores range from 0 to 4, with higher scores indicating greater fear. The outcome will be the change in fear score from baseline to immediately after the intervention.
3 secondary outcomes
Cooperation During Anesthesia Induction
Time frame: During anesthesia induction, after transfer to the operating room on the day of surgery.
Postoperative Pain
Time frame: Day of surgery, after return to the hospital room
Parent Experience and Satisfaction
Time frame: At hospital discharge, up to 72 hours after surgery
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 28 Sep 2026.
- Results publication: PubMed 36700361Franco Castanys T, Jimenez Carrion A, Rodenas Gomez F, Clemente Garcia S, Melero Mascaray A, Janeiro Amela M, Busquets Bonet J. Effects of virtual tour on perioperative pediatric anxiety. Paediatr Anaesth. 2023 May;33(5):377-386. doi: 10.1111/pan.14639. Epub 2023 Feb 7.
- Results publication: PubMed 25010821Jenkins BN, Fortier MA, Kaplan SH, Mayes LC, Kain ZN. Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg. 2014 Sep;119(3):643-650. doi: 10.1213/ANE.0000000000000350.
- Results publication: PubMed 21806301McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NixiKit Virtual Reality Preparation and Standard Nursing Preoperative Preparation in people with Preoperative Anxiety and Fear, run by Fundación de investigación HM at 1 site in Spain.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. 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 Spain. 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?
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 Cayetana Ruiz Zaldibar, Dr (695829472, crzaldibar@ucjc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Preoperative Anxiety (time frame: From baseline (T0, immediately before intervention) to immediately after intervention (T1, approximately 15-45 minutes after baseline). Same day, prior to surgery). The study lists 2 primary outcomes in all. 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 NCT07650695, which also lists 3 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 28 Sep 2026; AzTrials last refreshed its copy on 31 Oct 2026.