Surgery in ChildrenNCT07131982
The Effect of Informative Animated Videos Watched Before Surgery on Anxiety and Fear in Children and Their Mothers
A study testing Informative Animated Video to be Viewed with Virtual Reality Glasses in people with Surgery in Children, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
It is important to prepare children and their mothers psychologically for surgery. There are many initiatives to achieve this psychological preparation, including interactive educational booklets for children and their families, hospital tours, educational multimedia applications, web-based preparation programs… Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery in Children
- What is being tested?
- Informative Animated Video to be Viewed with Virtual Reality Glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Feb 2024to 15 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 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 7-13,
- Those who will undergo surgery for the first time,
- Able to read and write,
- Her mother and herself agreed to participate in the study,
- No communication problems,
- It will be done with children who can speak and understand Turkish and their mothers.
Who cannot join
- With developmental disabilities,
- Having a history of neurological disease or psychoactive drug use,
- Those with hearing and/or visual impairments,
- Children with a history of previous surgery and their mothers will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Watching Animation-Assisted Preoperative Informative Video Using Virtual Reality on Perioperative Anxiety and Fear in Children and Mothers: A Randomized Controlled Study
It is important to prepare children and their mothers psychologically for surgery. There are many initiatives to achieve this psychological preparation, including interactive educational booklets for children and their families, hospital tours, educational multimedia applications, web-based preparation programs, virtual reality applications, virtual tours, therapeutic games, hospital clowning, and educational coloring books. Among these initiatives, the immersive features of virtual reality glasses are seen as an effective method for distracting children from negative stimuli. Informing children before surgery is effective in increasing their sense of control during medical and surgical interventions. The information provided before surgery effectively reduces pain and fear in children. This research aims to reduce the anxiety and fear of children undergoing surgery and their mothers, as well as to facilitate the child's recovery after surgery. Additionally, reducing the mother's anxiety and fear will enable her to provide higher-quality care to her child during the postoperative process.
This study will be conducted using a prospective randomized controlled study design, matching children according to gender, age, and minor surgical reason, to determine the effect of animated videos shown through virtual reality glasses before surgery on perioperative anxiety and fear in children and their mothers.
Read more
The objectives of the study are:
- The animated video to be shown will reduce children's and mothers' fear of surgery.
- The animated video to be shown will reduce children's and mothers' perioperative anxiety.
Read the detailed description
Surgical procedures are difficult experiences that create stress and anxiety for children and their families. Children's dependence on others to fulfill their roles during the hospital stay and surgery can lead to a loss of control and anxiety. Furthermore, the disruption of physical integrity, pain, and discomfort can lead to stress and anxiety in children and their parents. Parental stress often manifests as anxiety, anger, fear, or apprehension. Children affected by their mothers' anxiety, who are their primary caregivers, may fear something bad will happen to them or that something is being hidden from them. Children's anxiety about surgery can lead to postoperative behavioral problems such as separation anxiety, eating disorders, nightmares, and enuresis.
Reducing children's anxiety in the preoperative period is crucial to preventing negative postoperative outcomes. Preparations for this include interactive educational booklets, hospital tours, educational multimedia applications, web-based preparation programs, virtual reality applications, virtual tours, therapeutic games, hospital clowning, and educational coloring books, among many other initiatives. Among these interventions, the immersive features of virtual reality headset technology are seen as an effective method for distracting children from negative stimuli. Virtual reality slows down the response to pain and anxiety in children. Recent studies have used virtual reality headsets to increase children's comfort and familiarity with medical procedures and treatment environments, and technology-based preoperative preparation interventions have been reported to be effective in alleviating preoperative anxiety in children. The literature contains research findings on the effectiveness or ineffectiveness of methods used to reduce preoperative anxiety and fear in children. However, no studies have been found that evaluate the effects of animated videos shown to children on mothers and children. The purpose of this study was to determine the effect of animated videos viewed through virtual reality headsets before surgery on perioperative anxiety and fear in children and their mothers.
- Conditions
- Surgery in Children
- Being tested
- Informative Animated Video to be Viewed with Virtual Reality Glasses
- Keywords
- children, anxiety, surgery, fear
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informative Animated Video to be Viewed with Virtual Reality GlassesOther
No study has been found in the literature evaluating the effect of animated videos shown to children through virtual reality glasses on mothers and children. The aim of this study was to determine the effect of animated videos shown through virtual reality glasses before surgery on perioperative anxiety and fear in children and their mothers.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | On the morning of the surgery, before the operation, children and their mothers who are included in the training group will be administered the following questionnaires: the Physiological Parameters Measurement Form, the Children's Fear Scale, and the Multidimensional Perioperative Anxiety Scale for Children (for children) and the State Anxiety Inventory-Short Form (for mothers). After the scales are administered, a pre-recorded video content, approximately 5 minutes in length and written by the researchers, will be shown to the child and mother on the morning of the surgery using a Virtual Reality Headset. Fifteen minutes after the video presentation, the Physiological Parameters Measurement Form, Multidimensional Perioperative Anxiety Scale for Children, and Children's Fear Scale will be administered to the children, and the State Anxiety Inventory-Short Form will be administered to the mothers. One hour post-op, the Physiological Parameters Measurement Form, Multidimensional Periop Receives: Other: Informative Animated Video to be Viewed with Virtual Reality Glasses |
| control group | No intervention | No interventions other than clinical routines will be performed on children in the control group, and they will be evaluated during the standard care process. Before surgery, the Physiological Parameters Measurement Form, Children's Fear Scale, and Multidimensional Perioperative Anxiety Scale questions will be administered to children, and the State Anxiety Inventory-Short Form questions will be administered to mothers. The scales will be administered again 15 minutes after administration and at the 1-hour post-operative mark. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional Perioperative Anxiety Scale for Children
This scale was developed by Chow and colleagues to assess perioperative anxiety in children aged 7-13 years undergoing day surgery. As the score increases, anxiety increases. The scale is administered to children aged 7-13 years a total of three times: on the day the surgical procedure date is scheduled, on the day of the surgical procedure, and one month after the surgical procedure.
Measured: one month
Secondary outcomes (2)
Child Fear Scale
The Children's Fear Scale, developed by McMurtry and colleagues, is used to measure children's fears and anxieties.As the score increases, fear increases
Measured: one month
State-trait Anxiety Inventory
A form that measures state anxiety and trait anxiety. As the score increases, state-trait anxiety increases.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start29 Feb 2024
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgery in ChildrenStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Model description
- intervention group and control group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yağmur Sezer Efe, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131982
- Sponsor's protocol ID
- ERU-SBF-YZE-01
- Status last verified
- Mar 2026
- First submitted
- 13 Aug 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Efe YS, Usta E, Roba AA, Calisir O, Turan C. Preoperative virtual reality education for children undergoing surgery: a randomized controlled trial. Sci Rep. 2026 Jun 23. doi: 10.1038/s41598-026-58392-3. Online ahead of print.
PubMed 42337300
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Watching Animation-Assisted Preoperative Informative Video Using Virtual Reality on Perioperative Anxiety and Fear in Children and Mothers: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07131982
- Acronym / sponsor ID
- ERU-SBF-YZE-01
- Conditions
- Surgery in Children
- Keywords
- children, anxiety, surgery, fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 20 Aug 2025 (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.
It is important to prepare children and their mothers psychologically for surgery. There are many initiatives to achieve this psychological preparation, including interactive educational booklets for children and their families, hospital tours, educational multimedia applications, web-based preparation programs, virtual reality applications, virtual tours, therapeutic games, hospital clowning, and educational coloring books. Among these initiatives, the immersive features of virtual reality glasses are seen as an effective method for distracting children from negative stimuli. Informing children before surgery is effective in increasing their sense of control during medical and surgical interventions. The information provided before surgery effectively reduces pain and fear in children. This research aims to reduce the anxiety and fear of children undergoing surgery and their mothers, as well as to facilitate the child's recovery after surgery. Additionally, reducing the mother's anxiety and fear will enable her to provide higher-quality care to her child during the postoperative process.
This study will be conducted using a prospective randomized controlled study design, matching children according to gender, age, and minor surgical reason, to determine the effect of animated videos shown through virtual reality glasses before surgery on perioperative anxiety and fear in children and their mothers.
The objectives of the study are:
- The animated video to be shown will reduce children's and mothers' fear of surgery.
- The animated video to be shown will reduce children's and mothers' perioperative anxiety.
Detailed description
Surgical procedures are difficult experiences that create stress and anxiety for children and their families. Children's dependence on others to fulfill their roles during the hospital stay and surgery can lead to a loss of control and anxiety. Furthermore, the disruption of physical integrity, pain, and discomfort can lead to stress and anxiety in children and their parents. Parental stress often manifests as anxiety, anger, fear, or apprehension. Children affected by their mothers' anxiety, who are their primary caregivers, may fear something bad will happen to them or that something is being hidden from them. Children's anxiety about surgery can lead to postoperative behavioral problems such as separation anxiety, eating disorders, nightmares, and enuresis.
Reducing children's anxiety in the preoperative period is crucial to preventing negative postoperative outcomes. Preparations for this include interactive educational booklets, hospital tours, educational multimedia applications, web-based preparation programs, virtual reality applications, virtual tours, therapeutic games, hospital clowning, and educational coloring books, among many other initiatives. Among these interventions, the immersive features of virtual reality headset technology are seen as an effective method for distracting children from negative stimuli. Virtual reality slows down the response to pain and anxiety in children. Recent studies have used virtual reality headsets to increase children's comfort and familiarity with medical procedures and treatment environments, and technology-based preoperative preparation interventions have been reported to be effective in alleviating preoperative anxiety in children. The literature contains research findings on the effectiveness or ineffectiveness of methods used to reduce preoperative anxiety and fear in children. However, no studies have been found that evaluate the effects of animated videos shown to children on mothers and children. The purpose of this study was to determine the effect of animated videos viewed through virtual reality headsets before surgery on perioperative anxiety and fear in children and their mothers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention group and control group
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Other: Informative Animated Video to be Viewed with Virtual Reality GlassesOn the morning of the surgery, before the operation, children and their mothers who are included in the training group will be administered the following questionnaires: the Physiological Parameters Measurement Form, the Children's Fear Scale, and the Multidimensional Perioperative Anxiety Scale for Children (for children) and the State Anxiety Inventory-Short Form (for mothers). After the scales are administered, a pre-recorded video content, approximately 5 minutes in length and written by the researchers, will be shown to the child and mother on the morning of the surgery using a Virtual Reality Headset. Fifteen minutes after the video presentation, the Physiological Parameters Measurement Form, Multidimensional Perioperative Anxiety Scale for Children, and Children's Fear Scale will be administered to the children, and the State Anxiety Inventory-Short Form will be administered to the mothers. One hour post-op, the Physiological Parameters Measurement Form, Multidimensional Periop |
| control group | No intervention | –No interventions other than clinical routines will be performed on children in the control group, and they will be evaluated during the standard care process. Before surgery, the Physiological Parameters Measurement Form, Children's Fear Scale, and Multidimensional Perioperative Anxiety Scale questions will be administered to children, and the State Anxiety Inventory-Short Form questions will be administered to mothers. The scales will be administered again 15 minutes after administration and at the 1-hour post-operative mark. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 7-13,
- Those who will undergo surgery for the first time,
- Able to read and write,
- Her mother and herself agreed to participate in the study,
- No communication problems,
Key exclusion criteria (4 listed)
- With developmental disabilities,
- Having a history of neurological disease or psychoactive drug use,
- Those with hearing and/or visual impairments,
- Children with a history of previous surgery and their mothers will not be included in the study.
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 |
|---|---|---|
| Informative Animated Video to be Viewed with Virtual Reality GlassesNo study has been found in the literature evaluating the effect of animated videos shown to children through virtual reality glasses on mothers and children. The aim of this study was to determine the effect of animated videos shown through virtual reality glasses before surgery on perioperative anxiety and fear in children and their mothers. | Other | intervention group |
Primary outcome
Multidimensional Perioperative Anxiety Scale for Children
Time frame: one month
This scale was developed by Chow and colleagues to assess perioperative anxiety in children aged 7-13 years undergoing day surgery. As the score increases, anxiety increases. The scale is administered to children aged 7-13 years a total of three times: on the day the surgical procedure date is scheduled, on the day of the surgical procedure, and one month after the surgical procedure.
2 secondary outcomes
Child Fear Scale
Time frame: one month
State-trait Anxiety Inventory
Time frame: one month
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 3 Mar 2026.
- Derived from this study: PubMed 42337300Efe YS, Usta E, Roba AA, Calisir O, Turan C. Preoperative virtual reality education for children undergoing surgery: a randomized controlled trial. Sci Rep. 2026 Jun 23. doi: 10.1038/s41598-026-58392-3. Online ahead of print.
- 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.
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 Informative Animated Video to be Viewed with Virtual Reality Glasses in people with Surgery in Children, run by TC Erciyes 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 6 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 3 Mar 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?
Multidimensional Perioperative Anxiety Scale for Children (time frame: one month). 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 NCT07131982, which also lists 1 linked publication.
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 3 Mar 2026.