RandomizedNCT05373797
The Effect of Virtual Reality Glasses Used During Burn Dressing in Children on Parents' Satisfaction Level and Anxiety
An observational study of Randomized, run by Ondokuz Mayıs University at 2 sites in Turkey (Türkiye).
Trial summary
The study was planned as a prospective randomized controlled study and was carried out in the Training and Research Hospital burn unit outpatient clinic between 05.7.2021-1.04.2022. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Randomized
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 7 May 2021to 4 May 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
- parents
- read and write,
- understand Turkish,
Who cannot join
- under the age of 18
- do not want to participate in the study
- cannot be pregnant
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Samsun Health Directorate
Samsun, İlkadım
19May University
Samsun, 34100
About this study
Official title: Determination of the Effect of Virtual Reality Glasses Used During Burn Dressing in Children on Parents' Satisfaction Level and Anxiety
The study was planned as a prospective randomized controlled study and was carried out in the Training and Research Hospital burn unit outpatient clinic between 05.7.2021-1.04.2022. The population of the study consisted of the parents of children aged 5-10 years who applied to the burn unit polyclinic for dressing between the dates of the study. A total of 52 people were included in the research group. Data were collected by using the "Survey Form" consisting of 10 questions, "Newcastle Nursing Satisfaction Scale" and "Beck Anxiety Scale".
Read the detailed description
In this study, the "Beck Anxiety Inventory" was applied to the parents before and after the burn dressing, while the "Newcastle Satisfaction with Nursing Scale" was applied only after dressing.
Control Group (n=26): "Parent Information Form" and "Beck Anxiety Inventory" were completed by the researcher nurse after obtaining the consent of the family and the children in the control group. After filling out the form, the parent and child were taken to the dressing room, and the researcher nurse was with both the child and the parent throughout the dressing and answered all the questions that the parent and child had. After the dressing, the child was taken to the waiting room and it was waited for the child to calm down, and "Beck Anxiety Inventory" and "Newcastle Satisfaction with Nursing Scale" were applied to the parent by the researcher nurse.
The Intervention Group (n=26): "Parent Information Form" and "Beck Anxiety Inventory" were completed by the researcher nurse after obtaining the consent of the family and the children in the intervention group. Then, the parent and child were taken to the dressing room and the child was put on virtual reality headsets and he/she watched a cartoon he/she liked. During this time, all the questions that both the child and the parent had have been answered. After the dressing, the virtual reality headsets were removed, the child was taken to the waiting room and the "Beck Anxiety Inventory" and "Newcastle Satisfaction with Nursing Scale" were applied to the parents. During all these processes, procedures were carried out in accordance with the protocols and principles established within the scope of the "COVID-19 Pandemic Measures" published by the Ministry of Health.
- Conditions
- Randomized
- Being tested
- Procedures performed on the experimental and control groups
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedures performed on the experimental and control groupsBehavioural
Also called experimental and control group
Intervention Group:26 Control Group (n=26):
| Study group | Role | What they receive |
|---|---|---|
| experimental and control group | experimental: 26 control group:26 Receives: Behavioral: Procedures performed on the experimental and control groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Virtual Reality Glasses Used During Burn Dressing in Children on Parents' Satisfaction Level and Anxiety
Using virtual reality glasses lowers parental anxiety
Measured: May 2022- October2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start7 May 2021
- Primary completion4 Apr 2022
- Study completion4 May 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)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ümmühan kılıç, Ondokuz Mayıs University
- Investigators
- Esra TURAL, PhD, Principal investigator, omu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373797
- Sponsor's protocol ID
- nineteen may university
- Other IDs
- health
- Status last verified
- May 2022
- First submitted
- 27 Apr 2022
- Last updated
- 15 Jul 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 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Virtual Reality Glasses Used During Burn Dressing in Children on Parents' Satisfaction Level and Anxiety
- ClinicalTrials.gov ID
- NCT05373797
- Acronym / sponsor ID
- nineteen may university
- Conditions
- Randomized
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 13 May 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.
The study was planned as a prospective randomized controlled study and was carried out in the Training and Research Hospital burn unit outpatient clinic between 05.7.2021-1.04.2022. The population of the study consisted of the parents of children aged 5-10 years who applied to the burn unit polyclinic for dressing between the dates of the study. A total of 52 people were included in the research group. Data were collected by using the "Survey Form" consisting of 10 questions, "Newcastle Nursing Satisfaction Scale" and "Beck Anxiety Scale".
Detailed description
In this study, the "Beck Anxiety Inventory" was applied to the parents before and after the burn dressing, while the "Newcastle Satisfaction with Nursing Scale" was applied only after dressing.
Control Group (n=26): "Parent Information Form" and "Beck Anxiety Inventory" were completed by the researcher nurse after obtaining the consent of the family and the children in the control group. After filling out the form, the parent and child were taken to the dressing room, and the researcher nurse was with both the child and the parent throughout the dressing and answered all the questions that the parent and child had. After the dressing, the child was taken to the waiting room and it was waited for the child to calm down, and "Beck Anxiety Inventory" and "Newcastle Satisfaction with Nursing Scale" were applied to the parent by the researcher nurse.
The Intervention Group (n=26): "Parent Information Form" and "Beck Anxiety Inventory" were completed by the researcher nurse after obtaining the consent of the family and the children in the intervention group. Then, the parent and child were taken to the dressing room and the child was put on virtual reality headsets and he/she watched a cartoon he/she liked. During this time, all the questions that both the child and the parent had have been answered. After the dressing, the virtual reality headsets were removed, the child was taken to the waiting room and the "Beck Anxiety Inventory" and "Newcastle Satisfaction with Nursing Scale" were applied to the parents. During all these processes, procedures were carried out in accordance with the protocols and principles established within the scope of the "COVID-19 Pandemic Measures" published by the Ministry of Health.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental and control group | – | Behavioral: Procedures performed on the experimental and control groupsexperimental: 26 control group:26 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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 (3 listed)
- parents
- read and write,
- understand Turkish,
Key exclusion criteria (3 listed)
- under the age of 18
- do not want to participate in the study
- cannot be pregnant
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 |
|---|---|---|
| Procedures performed on the experimental and control groupsAlso: experimental and control groupIntervention Group:26 Control Group (n=26): | Behavioural | experimental and control group |
Primary outcome
The Effect of Virtual Reality Glasses Used During Burn Dressing in Children on Parents' Satisfaction Level and Anxiety
Time frame: May 2022- October2022
Using virtual reality glasses lowers parental anxiety
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 15 Jul 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.
Esra TURAL, PhD principal investigator
omu
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 3 inclusion and 3 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 15 Jul 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?
The Effect of Virtual Reality Glasses Used During Burn Dressing in Children on Parents' Satisfaction Level and Anxiety (time frame: May 2022- October2022). 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 15 Jul 2022.