RandomizedNCT05490693
The Effect of Virtual Reality Glasses Used During Burn Dressing in Children on Pain, Anxiety and Fear
An observational study of Randomized, run by Ondokuz Mayıs University at 2 sites in Turkey (Türkiye).
Trial summary
This work; It was planned as a randomized controlled study to determine the effect of watching cartoons with virtual reality glasses during burn dressing of children aged 5-10 years who applied to the Training and Research Hospital Burn Unit Polyclinic on the feeling of pain, anxiety and fear in children. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Randomized
- What is being tested?
- Experimental group
- How many people
- 1 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 24 Jul 2022to 2 Oct 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Study population: In order to determine the number of samples, power analysis was performed using the G*power program. The effect size coefficient was calculated by using the Newcastle satisfaction scale averages in source 1 (thesis), and the effect size = 0.76, and it was decided to recruit at least 26 people in each group in order to obtain 80% power at the ɑ=0.05 level, a total of 52 people in the two groups.
Who may be able to join
- The child and family agree to participate in the research,
- The child does not have a disease that causes chronic pain,
- The child is between the ages of 5-10,
- 1st and 2nd degree burns of less than 10% of the body surface area of the child,
- Local burn, no facial burn
- The child has no mental or neurological disability
- Failure to intervene in the child with general anesthesia
- The child has no eye problems
Who cannot join
- Child and family refusal to participate in the study
- 3rd and 4th degree burns of more than 10% of the body surface area of the child,
- The child is less than 5 years old and over 10 years old
- The child has a mental or neurological disability
- Intervention of the child with general anesthesia
- The child has an eye problem
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Omü
Samsun, İlkadım
19May University
Samsun, 34100
About this study
This work; It was planned as a randomized controlled study to determine the effect of watching cartoons with virtual reality glasses during burn dressing of children aged 5-10 years who applied to the Training and Research Hospital Burn Unit Polyclinic on the feeling of pain, anxiety and fear in children.
Read the detailed description
The study will be applied to children in the 5-10 group who will undergo burn dressing. During the dressing, children will be watched cartoons with virtual reality glasses and pain, anxiety and fear will be looked at before and after the dressing. The children in the control group will be given routine applications of the clinic.
- Conditions
- Randomized
- Being tested
- Experimental group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Also called control group
Experimental group: 26 control group group: 26
What is being measured
The primary outcome is the main question the study is designed to answer.
pain, anxiety, fear scores,
We will evaluate the pain, anxiety, fear score with the Wong Baker Pain Scale before and after dressing in the trial and control group.reality glasses compared to the control group.
Measured: July 2022-October 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start24 Jul 2022
- Primary completion5 Sep 2022
- Study completion2 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RandomizedStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ümmühan kılıç, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490693
- Sponsor's protocol ID
- OMU
- Status last verified
- Dec 2022
- First submitted
- 1 Aug 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses Used During Burn Dressing in Children on Pain, Anxiety and Fear
- ClinicalTrials.gov ID
- NCT05490693
- Acronym / sponsor ID
- OMU
- Conditions
- Randomized
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 24 Jul 2022 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 2 Oct 2022 (actual)
- First posted
- 8 Aug 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.
This work; It was planned as a randomized controlled study to determine the effect of watching cartoons with virtual reality glasses during burn dressing of children aged 5-10 years who applied to the Training and Research Hospital Burn Unit Polyclinic on the feeling of pain, anxiety and fear in children.
Detailed description
The study will be applied to children in the 5-10 group who will undergo burn dressing. During the dressing, children will be watched cartoons with virtual reality glasses and pain, anxiety and fear will be looked at before and after the dressing. The children in the control group will be given routine applications of the clinic.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- In order to determine the number of samples, power analysis was performed using the G*power program. The effect size coefficient was calculated by using the Newcastle satisfaction scale averages in source 1 (thesis), and the effect size = 0.76, and it was decided to recruit at least 26 people in each group in order to obtain 80% power at the ɑ=0.05 level, a total of 52 people in the two groups.
Key inclusion criteria (8 listed)
- The child and family agree to participate in the research,
- The child does not have a disease that causes chronic pain,
- The child is between the ages of 5-10,
- 1st and 2nd degree burns of less than 10% of the body surface area of the child,
- Local burn, no facial burn
Key exclusion criteria (6 listed)
- Child and family refusal to participate in the study
- 3rd and 4th degree burns of more than 10% of the body surface area of the child,
- The child is less than 5 years old and over 10 years old
- The child has a mental or neurological disability
- Intervention of the child with general anesthesia
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 |
|---|---|---|
| Experimental groupAlso: control groupExperimental group: 26 control group group: 26 | Other | – |
Primary outcome
pain, anxiety, fear scores,
Time frame: July 2022-October 2022
We will evaluate the pain, anxiety, fear score with the Wong Baker Pain Scale before and after dressing in the trial and control group.reality glasses compared to the control group.
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 6 Dec 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Randomized, run by Ondokuz Mayıs University at 2 sites 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 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: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
pain, anxiety, fear scores, (time frame: July 2022-October 2022). 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 6 Dec 2022.