Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607682307645 Date of Registration: 24/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Virtual Reality for Reducing Preoperative Anxiety in Children Undergoing Surgery
Official scientific title Effectiveness of Virtual Reality Intervention in Reducing Preoperative Anxiety and Distress Among Children Undergoing Elective Surgery: A Quasi-Experimental Study
Brief summary describing the background and objectives of the trial Children undergoing elective surgery often experience preoperative anxiety and psychological distress due to fear of the unfamiliar hospital environment, anesthesia, surgical procedures, pain, and separation from parents. High levels of anxiety before surgery may negatively affect children’s cooperation, postoperative recovery, pain perception, and psychological well-being. Virtual reality is a promising non-pharmacological intervention that may help reduce anxiety by providing children with an immersive, child-friendly simulation of the surgical environment before the operation. This exposure may familiarize children with the preoperative area, operating room, anesthesia equipment, and recovery process, thereby reducing fear and uncertainty. This trial aims to evaluate the effectiveness of a virtual reality intervention in reducing preoperative anxiety and distress symptoms among children aged 6–12 years undergoing elective surgery. The study compares children who receive a virtual reality preparation session before surgery with children who receive routine preoperative care. The primary objective is to assess whether virtual reality reduces preoperative anxiety measured by the Modified Yale Preoperative Anxiety Scale. Secondary objectives are to evaluate its effect on pediatric distress symptoms measured by the Pediatric Symptom Checklist and to assess mothers’ satisfaction with healthcare services using the Patient Satisfaction Questionnaire. The study is conducted among children undergoing elective orofacial and ear, nose, and throat surgeries at Mostafa Hassan Children’s Hospital, Fayoum University Hospitals.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/11/2024
Actual trial start date 01/11/2024
Anticipated date of last follow up 01/04/2025
Actual Last follow-up date 01/04/2025
Anticipated target sample size (number of participants) 104
Actual target sample size (number of participants) 104
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation Sequence/Code was not concealed Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Virtual Reality Intervention A single session of 15–20 minutes VR exposure once before surgery One-time intervention on the day before surgery (or preoperative period within 24 hours before surgery) Children in the intervention group received a single preoperative virtual reality session using VR headsets and smartphone-based 3D immersive videos. The VR experience lasted approximately 15–20 minutes and simulated the preoperative journey, including hospital admission, operating room environment, anesthesia induction, and postoperative recovery. The intervention aimed to familiarize children with the surgical process and reduce anxiety and distress prior to elective surgery. 52
Control Group Routine Preoperative Care Standard hospital preoperative preparation only (no VR exposure), provided once before surgery Single routine preoperative session within 24 hours before surgery (standard care period) Children in the control group received routine preoperative care provided by the hospital. This included standard nursing preparation, monitoring of vital signs, and provision of routine information about the surgical procedure without any virtual reality exposure or additional psychological distraction techniques. 52 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children aged 6 to 12 years Scheduled for elective surgery (orofacial or ENT procedures) Medically stable and fit for surgery Children able to understand and participate in the intervention Children accompanied by their mothers who provide informed consent No prior exposure to virtual reality intervention in the perioperative period Parents willing to allow participation in the study Children with cognitive impairment or developmental delay Children with visual or auditory impairment Children who are medically unstable or critically ill Children receiving pharmacological sedation or other anxiety-reducing interventions prior to surgery Children with anxiety due to causes unrelated to surgery Children who refuse to participate or withdraw consent Children with contraindications to VR use (e.g., severe motion sickness, epilepsy history if applicable per hospital policy) Child: 6 Year-12 Year 6 Year(s) 12 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/09/2024 Ethical Research Committee Faculty of Medicine Fayoum University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Fayoum University, Al-Mashtal Street Fayoum 63514 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Preoperative anxiety level in children undergoing elective surgery (measured using Modified Yale Preoperative Anxiety Scale - mYPAS) Before intervention as baseline and immediately after the virtual reality intervention prior to surgery preoperative period, within the same day or within 24 hours before surgery
Secondary Outcome Pediatric distress symptoms measured by Pediatric Symptom Checklist (PSC) and parental satisfaction measured by Patient Satisfaction Questionnaire (PSQ-18) Pre-intervention baseline and post-intervention preoperative assessment same within the same day or within 24 hours before surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mostafa Hassan Children Hospital Fayoum University Hospitals Mostafa Hassan street Fayoum 63514 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amany Ibrahim Abdalla Faculty of Nursing Fayoum University Fayoum 63514 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Fayoum University Faculty of Nursing Fayoum University Fayoum 63514 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amany Ibrahim Abdalla aai03@fayoum.edu.eg 03567568 Fayoum street
City Postal code Country Position/Affiliation
Fayoum 63514 Egypt Pediatric nursing Faculty of nursing Fayoum University Fayoum Egypt
Role Name Email Phone Street address
Scientific Enquiries Abdelaziz Hendy a.hendy@qu.edu.sa 99374893 Abbasia
City Postal code Country Position/Affiliation
Cairo 190293 Egypt Pediatric nursing Faculty of nursing Ain Shams University Cairo Egypt
Role Name Email Phone Street address
Public Enquiries Rahma Elsayed Abdel Aziz dr.rahma.alsayed@nursing.asu.edy.eg 019827322 Abbasia
City Postal code Country Position/Affiliation
Cairo Egypt Pediatric nursing Faculty of nursing Ain Shams University Cairo Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data will include anonymized demographic characteristics, preoperative anxiety scores measured by the modified Yale Preoperative Anxiety Scale (mYPAS), pediatric symptom/checklist scores, and parental satisfaction scores measured by the PSQ-18, as collected during the study. Informed Consent Form,Statistical Analysis Plan,Study Protocol De-identified data will be available after publication of the main study results, approximately 6–12 months after publication, or upon reasonable request, subject to institutional approval. De-identified data will be made available upon reasonable request to qualified researchers who provide a scientifically valid proposal and evidence of ethical approval. Data access will be subject to institutional approval, confidentiality requirements, and a signed data use agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 17/07/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 17/07/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 24/06/2026 Write the actual name of PI Self funded study, Faculty of Nursing Fayoum University, Fayoum, 63514, Egypt, Self Funded, Amany Ibrahim Abdalla, Faculty of Nursing Fayoum University, Fayoum, 63514, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 24/06/2026 The reporting section has been updated to include the required IPD sharing statement and to clarify the availability of summary results in accordance with registry requirements. Individual participant data includes anonymized demographic characteristics, preoperative anxiety scores (mYPAS), pediatric symptom scores (PSC), and parental satisfaction scores (PSQ-18) collected during the study De-identified individual participant data will include anonymized demographic characteristics, preoperative anxiety scores measured by the modified Yale Preoperative Anxiety Scale (mYPAS), pediatric symptom/checklist scores, and parental satisfaction scores measured by the PSQ-18, as collected during the study.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 24/06/2026 The reporting section has been updated to include the required IPD sharing statement and to clarify the availability of summary results in accordance with registry requirements. After publication of study results (e.g., 6–12 months after publication) or upon reasonable request De-identified data will be available after publication of the main study results, approximately 6–12 months after publication, or upon reasonable request, subject to institutional approval.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 24/06/2026 The reporting section has been updated to include the required IPD sharing statement and to clarify the availability of summary results in accordance with registry requirements. De-identified data available upon reasonable request from qualified researchers with ethical approval; data use subject to institutional approval and confidentiality requirements De-identified data will be made available upon reasonable request to qualified researchers who provide a scientifically valid proposal and evidence of ethical approval. Data access will be subject to institutional approval, confidentiality requirements, and a signed data use agreement.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 17/07/2026 The Reporting section was updated to include baseline characteristics, participant flow, adverse-event information, and primary and secondary outcome results in response to the trial reviewer’s comments. No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 17/07/2026 The Reporting section was updated to include baseline characteristics, participant flow, adverse-event information, and primary and secondary outcome results in response to the trial reviewer’s comments. 41516_28676_1045.pdf