Pediatric Surgical PatientsNCT07415343
Impact of Virtual Reality on Fear and Pain in Pediatric Patients
A study testing virtual reality in people with Pediatric Surgical Patients, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Preoperative fear and postoperative pain are common problems in children undergoing surgery and may adversely affect perioperative outcomes. Nonpharmacological, child-centered interventions that support emotional preparation are increasingly emphasized in pediatric nursing care. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Pediatric Surgical Patients
- What is being tested?
- virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Jan 2026
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child and parent provided informed consent,
- the child was aged 5-12 years,
- scheduled to undergo surgery for the first time
Who cannot join
- they had any chronic medical illness,
- exhibited cognitive impairment or mental retardation,
- had previously undergone any surgical intervention,
- were scheduled for a complex surgical procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Virtual Reality on Fear and Pain in Pediatric Patients Undergoing Preoperative Preparation: A Randomized Controlled Study
Preoperative fear and postoperative pain are common problems in children undergoing surgery and may adversely affect perioperative outcomes. Nonpharmacological, child-centered interventions that support emotional preparation are increasingly emphasized in pediatric nursing care. :To investigate the effects of virtual reality on preoperative fear and postoperative pain in children aged 5-12 years undergoing surgery.This randomized controlled study was conducted in accordance with the CONSORT guidelines. A total of 74 children were randomly assigned using block randomization to either the Educational Animation (VR) group (n = 36) or the control group (n = 38). Data were collected using an information form, the Children's Fear Scale, and the Wong-Baker Faces Pain Rating Scale. Preoperative fear was assessed by child, nurse, and researcher ratings, while postoperative pain was evaluated at two time points by parents, nurses, and the researcher. No significant differences were found between the VR and control groups in preoperative fear scores based on child, nurse, or researcher assessments (p > .05). However, within the VR group, preoperative fear scores significantly decreased after the intervention across all evaluators (p < .001). Postoperative pain scores were significantly lower in the VR group compared with the control group at both postoperative assessments according to parent, nurse, and researcher ratings (p < .05 for all). VR-based educational interventions appear to be an effective and feasible, nurse-led nonpharmacological approach for reducing preoperative fear and postoperative pain in pediatric surgical patients. Integrating VR into routine preoperative nursing care may enhance children's perioperative experiences and support child-centered care practices.
- Conditions
- Pediatric Surgical Patients
- Being tested
- virtual reality
- Keywords
- pediatrics, nursing, fear, pain, preoperative preparation, virtual reality
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityOther
Children in the VR group viewed the preoperative preparation video, after which fear levels were reassessed to determine the immediate effect of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| VR Group | Experimental | Children in the intervention group watched a preoperative preparation video via a Virtual Reality (VR) headset Receives: Other: virtual reality |
| Control Group | No intervention | Children in the control group received routine preoperative preparation according to the clinic protocol, without any additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Fear measured by the Children's Fear Scale (CFS)
The Children's Fear Scale is a validated self-report tool consisting of five facial expressions representing increasing levels of fear. Scores range from 0 to 4, with higher scores indicating greater fear.
Measured: Preoperative period (immediately before surgery)
Secondary outcomes (1)
Postoperative Pain measured by the Wong-Baker FACES Pain Rating Scale (WBFPRS)
The Wong-Baker FACES Pain Rating Scale is a validated pain assessment tool scored from 0 to 10. Higher scores indicate greater pain intensity.
Measured: Postoperative 1st hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Feb 2024
- Primary completion1 Nov 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Surgical PatientsStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir Bakircay University
- Responsible party
- Principal investigator, Merve Gümüş, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415343
- Sponsor's protocol ID
- 872
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Can be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Virtual Reality on Fear and Pain in Pediatric Patients Undergoing Preoperative Preparation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07415343
- Acronym / sponsor ID
- 872
- Conditions
- Pediatric Surgical Patients
- Keywords
- pediatrics, nursing, fear, pain, preoperative preparation, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Izmir Bakircay University
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 17 Feb 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.
Preoperative fear and postoperative pain are common problems in children undergoing surgery and may adversely affect perioperative outcomes. Nonpharmacological, child-centered interventions that support emotional preparation are increasingly emphasized in pediatric nursing care. :To investigate the effects of virtual reality on preoperative fear and postoperative pain in children aged 5-12 years undergoing surgery.This randomized controlled study was conducted in accordance with the CONSORT guidelines. A total of 74 children were randomly assigned using block randomization to either the Educational Animation (VR) group (n = 36) or the control group (n = 38). Data were collected using an information form, the Children's Fear Scale, and the Wong-Baker Faces Pain Rating Scale. Preoperative fear was assessed by child, nurse, and researcher ratings, while postoperative pain was evaluated at two time points by parents, nurses, and the researcher. No significant differences were found between the VR and control groups in preoperative fear scores based on child, nurse, or researcher assessments (p > .05). However, within the VR group, preoperative fear scores significantly decreased after the intervention across all evaluators (p < .001). Postoperative pain scores were significantly lower in the VR group compared with the control group at both postoperative assessments according to parent, nurse, and researcher ratings (p < .05 for all). VR-based educational interventions appear to be an effective and feasible, nurse-led nonpharmacological approach for reducing preoperative fear and postoperative pain in pediatric surgical patients. Integrating VR into routine preoperative nursing care may enhance children's perioperative experiences and support child-centered care practices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR Group | Experimental | Other: virtual realityChildren in the intervention group watched a preoperative preparation video via a Virtual Reality (VR) headset |
| Control Group | No intervention | –Children in the control group received routine preoperative preparation according to the clinic protocol, without any additional intervention. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- child and parent provided informed consent,
- the child was aged 5-12 years,
- scheduled to undergo surgery for the first time
Key exclusion criteria (4 listed)
- they had any chronic medical illness,
- exhibited cognitive impairment or mental retardation,
- had previously undergone any surgical intervention,
- were scheduled for a complex surgical procedure
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 realityChildren in the VR group viewed the preoperative preparation video, after which fear levels were reassessed to determine the immediate effect of the intervention. | Other | VR Group |
Primary outcome
Preoperative Fear measured by the Children's Fear Scale (CFS)
Time frame: Preoperative period (immediately before surgery)
The Children's Fear Scale is a validated self-report tool consisting of five facial expressions representing increasing levels of fear. Scores range from 0 to 4, with higher scores indicating greater fear.
1 secondary outcome
Postoperative Pain measured by the Wong-Baker FACES Pain Rating Scale (WBFPRS)
Time frame: Postoperative 1st hour
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 17 Feb 2026.
- Individual participant dataSharing planned: Undecided. Can be shared upon request.
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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 in people with Pediatric Surgical Patients, run by Ege University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 17 Feb 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 Turkey (Türkiye). 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?
Preoperative Fear measured by the Children's Fear Scale (CFS) (time frame: Preoperative period (immediately before surgery)). 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 17 Feb 2026.