ChildNCT05543876
The Effect of Video Watching With Virtual Reality Glasses on Pain and Fear of Children
A study testing suturing procedure in people with Child and Pain, run by Zühal Artuvan at 1 site in Turkey (Türkiye).
Trial summary
IInvasive procedures such as suturing cause pain and fear in children. The high level of pain and fear of children makes it difficult to adapt to the procedure. It is a randomized controlled study planned to examine the effect of watching videos with virtual reality glasses as a distraction method while suturing in… Read more about this study
- Who is it for?
- Ages 7 to 12 years
- What is being tested?
- suturing procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 31 Jul 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7-12 years,
- Suture the emergency room on 01 October 2022 - 31 March 2023 children applying for expulsion,
- Informed volunteer signers (child and parent),
- Children without mental and developmental retardation,
- No history of epilepsy,
- Have not taken painkillers in the last 6 hours,
- There will be no stitches around the eyes and head (where the virtual reality glasses will coincide) kids
- They are children who can speak and communicate in Turkish.
Who cannot join
- Children under 7 years old and over 12 years old,
- Children who applied to the emergency room for suturing except between 01 October 2022 - 31 March 2023,
- Those who did not sign the informed consent form (child and parent),
- Children with mental and developmental retardation, with a history of epilepsy,
- Have taken painkillers in the last 6 hours,
- Stitches will be placed around the eyes and head (where the virtual reality glasses will coincide) kids
- These are children who cannot speak Turkish and cannot be communicated.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mersin Toros Public Hospital
Mersin, Akdeniz, 33343
Zühal Artuvan, zuhalartuvan@gmail.com
About this study
Official title: The Effect of Video Watching With Virtual Reality Glasses on Pain and Fear of Children Presenting to the Emergency Department for Suture: A Randomized Controlled Study
IInvasive procedures such as suturing cause pain and fear in children. The high level of pain and fear of children makes it difficult to adapt to the procedure. It is a randomized controlled study planned to examine the effect of watching videos with virtual reality glasses as a distraction method while suturing in 7-12 age group children. Araştırma Acil Müdahale Odasında 01 Ekim 2022-31 Mart 2023 tarihlerinde yürütülmesi planlanmaktadır. In the collection of data; It is planned to use the Child Information Form, Wong-Baker Pain Scale, Child Fear Scale, which was created as a result of the literature review.
Read the detailed description
TChildren may feel pain and fear during invasive procedures in the emergency room. The methodology of the research planned to be conducted in the Emergency Service with the participation of 84 children who met the inclusion and exclusion criteria between 01 October 2022 and 31 March 2023 is explained below. Children who apply to the emergency department due to an incision come to the emergency room and suturing takes place in this room. Two nurses work in this room, which is approximately 20 square meters, located at the entrance of the emergency room. G*Power 3.1.9.4 program was used to determine the number of children to be included in the study and control groups. In order for the difference between the study and control groups to be statistically significant in the study to be conducted, taking into account the previous studies, a total of at least 84 children (42 studies, 42 control groups) with 0.55 effect size, 80% power and 5% type 1 error according to the t test) is planned to be included in the study.
Hypothesis 10: : There is no difference in pain scores before, during and after suturing procedure in children watching videos with virtual reality glasses compared to the control group.
Hypothesis 11: There is a difference in pain scores before, during and after suturing in children watching videos with virtual reality glasses compared to the control group.
Hypothesis 20: There is no difference between the fear scores of children watching videos with virtual reality glasses before, during and after suturing compared to the control group.
Hypothesis 22: There is a difference between the fear scores of children watching videos with virtual reality glasses before, during and after suturing compared to the control group.
84 children will be assigned as study (42) and control (42) by block randomization method. In the study, block randomization will be done to eliminate selection bias and to provide balance in the number of individuals. The determined blocks will be created by the statistician with the codes obtained from the permutation-based computer program (https://www.randomizer.org). Then, it will be determined whether A and B are the experimental or control group by drawing lots. After the patient is evaluated according to the inclusion/exclusion criteria, self-tests will be performed by obtaining consent. In the research, single blinding will be done so that the participants will not know that they are in the experimental and control groups. In the collection of data; It is planned to use the Child Information Form, Wong-Baker Pain Scale, Child Fear Scale, which was created as a result of the literature review. In the research, video surveillance with virtual reality glasses will form the intervention group. Three minutes before watching the video with the Virtual Reality Glasses, the cartoon chosen by the child (Puzzle Tower and Z Team from the cartoons broadcast on TRT children) will be started to be watched. Pain and fear scores will be recorded before, during and after the procedure. Each child will be shown 1 episode of cartoons. This time is approximately 15 minutes. The data will be recorded before, during and after the procedure by the parent and the researcher. Researchers will definitely not perform suturing. The same health personnel will perform the suturing procedure. During the suturing procedure, data will be collected from the child by the researcher. A statistical package program will be used in the evaluation of the data. The scale mean scores of the groups will be evaluated with descriptive statistics (mean, percentage, frequency, etc.). The relevant statistics will be made according to the normality of the distribution.
- Conditions
- Child, Pain, Fear, Suture, Virtual Reality
- Being tested
- suturing procedure
- Keywords
- suture, virtual reality glasses, pain, fear, child
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suturing procedureProcedure or surgery
Children presenting to the emergency department for suturing
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | group watching video with virtual reality glasses Receives: Procedure: suturing procedure |
| control group | No intervention | without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong Baker Pain score of the intervention group before the suture procedure
Wong Baker Pain Score; The pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.
Measured: Wong Baker pain score of the intervention group three minutes before the suture procedure
Wong Baker Pain Score during suture procedure of the intervention group
Wong Baker Pain Score; The pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.
Measured: Wong Baker Pain Score at the time of suturing of the intervention group
Wong Baker Pain Score of the control group before suture procedure
Wong Baker Pain Score; The pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.
Measured: Wong Baker Pain Score of the control group three minutes before the suture procedure
Wong Baker Pain Score during suture procedure of the control group
Wong Baker Pain Score;The pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.
Measured: Wong Baker Pain Score at the time of suturing of the control group
Child Fear Scale Score before the suture procedure of the intervention group
Child Fear Scale Score; It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.
Measured: Child Fear Scale Score 3 minutes before suture of the intervention group
Child Fear Scale Score during the suture procedure of the intervention group
Child Fear Scale Score; It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.
Measured: Child Fear Score at the time of suturing of the intervention group
Child Fear Scale Score before the suture procedure of the control group
Child Fear Scale Score; It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.
Measured: Child Fear Scale Score 3 minutes before suture of the control group
Child Fear Scale Score during the suture procedure of the control group
Child Fear Scale Score;It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.
Measured: Child Fear Score at the time of suturing of the control group
Wong Baker Pain score of the intervention group after the suture procedure
Wong Baker Pain ScoreThe pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.;
Measured: Wong Baker pain score of the intervention group three minutes after the suture procedure
Wong Baker Pain Score of the control group after suture procedure
Wong Baker Pain Score; The pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.
Measured: Wong Baker pain score of the control group three minutes after the suture procedure
Child Fear Scale Score of the intervention group after the suture procedure
Child Fear Scale Score;It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.
Measured: Child Fear Scale Score of the intervention group three minutes after the suture procedure
Child Fear Scale Score of the control group after the suture procedure
Child Fear Scale Score;It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.
Measured: Child Fear Scale Score of the control group three minutes after the suture procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Oct 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
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 ChildStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zühal Artuvan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zühal Artuvan, Mersin University
- Investigators
- Hacer Çetin, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543876
- Sponsor's protocol ID
- Zühal Artuvan
- Status last verified
- Jan 2024
- First submitted
- 13 Sep 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Artuvan Z, Cetin H, Turkmen AS. The effect of watching videos with virtual reality glasses on pain and fear in children who undergoing suturing in the emergency department: A randomized controlled trial. J Pediatr Nurs. 2025 May-Jun;82:31-37. doi: 10.1016/j.pedn.2025.02.017. Epub 2025 Feb 28.
PubMed 40022763
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video Watching With Virtual Reality Glasses on Pain and Fear of Children Presenting to the Emergency Department for Suture: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05543876
- Acronym / sponsor ID
- Zühal Artuvan
- Conditions
- Child, Pain, Fear, Suture, Virtual Reality
- Keywords
- suture, virtual reality glasses, pain, fear, child
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Zühal ArtuvanUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 16 Sep 2022 (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.
IInvasive procedures such as suturing cause pain and fear in children. The high level of pain and fear of children makes it difficult to adapt to the procedure. It is a randomized controlled study planned to examine the effect of watching videos with virtual reality glasses as a distraction method while suturing in 7-12 age group children. Araştırma Acil Müdahale Odasında 01 Ekim 2022-31 Mart 2023 tarihlerinde yürütülmesi planlanmaktadır. In the collection of data; It is planned to use the Child Information Form, Wong-Baker Pain Scale, Child Fear Scale, which was created as a result of the literature review.
Detailed description
TChildren may feel pain and fear during invasive procedures in the emergency room. The methodology of the research planned to be conducted in the Emergency Service with the participation of 84 children who met the inclusion and exclusion criteria between 01 October 2022 and 31 March 2023 is explained below. Children who apply to the emergency department due to an incision come to the emergency room and suturing takes place in this room. Two nurses work in this room, which is approximately 20 square meters, located at the entrance of the emergency room. G*Power 3.1.9.4 program was used to determine the number of children to be included in the study and control groups. In order for the difference between the study and control groups to be statistically significant in the study to be conducted, taking into account the previous studies, a total of at least 84 children (42 studies, 42 control groups) with 0.55 effect size, 80% power and 5% type 1 error according to the t test) is planned to be included in the study.
Hypothesis 10: : There is no difference in pain scores before, during and after suturing procedure in children watching videos with virtual reality glasses compared to the control group.
Hypothesis 11: There is a difference in pain scores before, during and after suturing in children watching videos with virtual reality glasses compared to the control group.
Hypothesis 20: There is no difference between the fear scores of children watching videos with virtual reality glasses before, during and after suturing compared to the control group.
Hypothesis 22: There is a difference between the fear scores of children watching videos with virtual reality glasses before, during and after suturing compared to the control group.
84 children will be assigned as study (42) and control (42) by block randomization method. In the study, block randomization will be done to eliminate selection bias and to provide balance in the number of individuals. The determined blocks will be created by the statistician with the codes obtained from the permutation-based computer program (https://www.randomizer.org). Then, it will be determined whether A and B are the experimental or control group by drawing lots. After the patient is evaluated according to the inclusion/exclusion criteria, self-tests will be performed by obtaining consent. In the research, single blinding will be done so that the participants will not know that they are in the experimental and control groups. In the collection of data; It is planned to use the Child Information Form, Wong-Baker Pain Scale, Child Fear Scale, which was created as a result of the literature review. In the research, video surveillance with virtual reality glasses will form the intervention group. Three minutes before watching the video with the Virtual Reality Glasses, the cartoon chosen by the child (Puzzle Tower and Z Team from the cartoons broadcast on TRT children) will be started to be watched. Pain and fear scores will be recorded before, during and after the procedure. Each child will be shown 1 episode of cartoons. This time is approximately 15 minutes. The data will be recorded before, during and after the procedure by the parent and the researcher. Researchers will definitely not perform suturing. The same health personnel will perform the suturing procedure. During the suturing procedure, data will be collected from the child by the researcher. A statistical package program will be used in the evaluation of the data. The scale mean scores of the groups will be evaluated with descriptive statistics (mean, percentage, frequency, etc.). The relevant statistics will be made according to the normality of the distribution.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Procedure: suturing proceduregroup watching video with virtual reality glasses |
| control group | No intervention | –without any intervention |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children aged 7-12 years,
- Suture the emergency room on 01 October 2022 - 31 March 2023 children applying for expulsion,
- Informed volunteer signers (child and parent),
- Children without mental and developmental retardation,
- No history of epilepsy,
Key exclusion criteria (7 listed)
- Children under 7 years old and over 12 years old,
- Children who applied to the emergency room for suturing except between 01 October 2022 - 31 March 2023,
- Those who did not sign the informed consent form (child and parent),
- Children with mental and developmental retardation, with a history of epilepsy,
- Have taken painkillers in the last 6 hours,
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 |
|---|---|---|
| suturing procedureChildren presenting to the emergency department for suturing | Procedure or surgery | intervention group |
Primary outcome
Wong Baker Pain score of the intervention group before the suture procedure
Time frame: Wong Baker pain score of the intervention group three minutes before the suture procedure
Wong Baker Pain Score; The pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.
Wong Baker Pain Score during suture procedure of the intervention group
Time frame: Wong Baker Pain Score at the time of suturing of the intervention group
Wong Baker Pain Score; The pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.
Wong Baker Pain Score of the control group before suture procedure
Time frame: Wong Baker Pain Score of the control group three minutes before the suture procedure
Wong Baker Pain Score; The pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.
Wong Baker Pain Score during suture procedure of the control group
Time frame: Wong Baker Pain Score at the time of suturing of the control group
Wong Baker Pain Score;The pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.
Child Fear Scale Score before the suture procedure of the intervention group
Time frame: Child Fear Scale Score 3 minutes before suture of the intervention group
Child Fear Scale Score; It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.
Child Fear Scale Score during the suture procedure of the intervention group
Time frame: Child Fear Score at the time of suturing of the intervention group
Child Fear Scale Score; It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.
Child Fear Scale Score before the suture procedure of the control group
Time frame: Child Fear Scale Score 3 minutes before suture of the control group
Child Fear Scale Score; It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.
Child Fear Scale Score during the suture procedure of the control group
Time frame: Child Fear Score at the time of suturing of the control group
Child Fear Scale Score;It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.
Wong Baker Pain score of the intervention group after the suture procedure
Time frame: Wong Baker pain score of the intervention group three minutes after the suture procedure
Wong Baker Pain ScoreThe pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.;
Wong Baker Pain Score of the control group after suture procedure
Time frame: Wong Baker pain score of the control group three minutes after the suture procedure
Wong Baker Pain Score; The pain level of the faces on the scale is explained to the child: "0=no pain……..10=unbearably severe pain".According to the scoring; 0-4 means mild pain, 5-6 moderate, 7-8 severe, 9-10 unbearable pain.
Child Fear Scale Score of the intervention group after the suture procedure
Time frame: Child Fear Scale Score of the intervention group three minutes after the suture procedure
Child Fear Scale Score;It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.
Child Fear Scale Score of the control group after the suture procedure
Time frame: Child Fear Scale Score of the control group three minutes after the suture procedure
Child Fear Scale Score;It consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety) with scores ranging from 0-4.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 40022763Artuvan Z, Cetin H, Turkmen AS. The effect of watching videos with virtual reality glasses on pain and fear in children who undergoing suturing in the emergency department: A randomized controlled trial. J Pediatr Nurs. 2025 May-Jun;82:31-37. doi: 10.1016/j.pedn.2025.02.017. Epub 2025 Feb 28.
- 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.
Hacer Çetin study director
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suturing procedure in people with Child and Pain, run by Zühal Artuvan 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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zühal Artuvan (+9003242337180 ext. 1761, zuhalartuvan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong Baker Pain score of the intervention group before the suture procedure (time frame: Wong Baker pain score of the intervention group three minutes before the suture procedure). The study lists 12 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 NCT05543876, 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 18 Jan 2024.