Fear of PainNCT06246877
Virtual Reality on Pain and Fear Level During Kirschner Wires (K-Wires) Removal in Children
A study testing virtual reality applied group in people with Fear of Pain, run by Ondokuz Mayıs University at 2 sites in Turkey (Türkiye).
Trial summary
This study will be conducted to examine the effect of virtual reality applied during K-wire removal and dressing on the pain and fear levels that develop due to the procedure in children aged 7-12 years who apply to the orthopedic outpatient clinic. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear of Pain
- What is being tested?
- virtual reality applied group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 12 Feb 2024to 31 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being a child between the ages of 7-12 who will have the K wire removed
- The child is not using glasses
- The child must be at a cognitive development level that can respond to video selection.
Who cannot join
- Having a disease that causes chronic pain
- The child must have used medication that would have an analgesic effect in the last 24 hours before the application.
- The child is wearing glasses
- The child has a mental or neurological disability
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ondokuz Mayıs University Faculty of Health Sciences
Samsun, Atakum, 55200
Esra Tural Büyük, pHD, 5052795196, esratural55@gmail.com
Bafra State Hospital
Samsun
About this study
Official title: Effect of Virtual Reality on Pain and Fear Level During Kirschner Wires (K-Wires) Removal and Dressing in Children
This study will be conducted to examine the effect of virtual reality applied during K-wire removal and dressing on the pain and fear levels that develop due to the procedure in children aged 7-12 years who apply to the orthopedic outpatient clinic.
Read the detailed description
Technology-based methods have now begun to be used to control anxiety and prevent pain that may occur before, during and after diagnosis and treatment procedures in children.
Virtual reality (VR), which is among the technological products, can be used in non-pharmacological methods as well as pharmacological methods.
It has been observed that VR, especially in children, creates an analgesic effect by mainly distracting the pain centers in the brain and evokes positive emotions with an anxiolytic effect.Since children do not want to see the procedures to be performed on them, virtual reality used during the procedure is one of the methods of diverting attention from the environment they are in. This study will be conducted to examine the effect of virtual reality applied during K-wire removal and dressing on the pain and fear levels that develop due to the procedure in children aged 7-12 years who apply to the orthopedic outpatient clinic.
- Conditions
- Fear of Pain
- Being tested
- virtual reality applied group
- Keywords
- child, Kirschner Wires, pain, fear, Virtual reality
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality applied groupBehavioural
Before the K-wire is removed and dressed, the three-dimensional video that the child likes and wants to watch will be placed on virtual reality glasses and attached to the child.
During the procedure, the child will be allowed to watch videos through virtual reality glasses.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality applied group | Experimental | Before the K-wire is removed and dressed, the three-dimensional video that the child likes and wants to watch will be placed on virtual reality glasses and attached to the child.
During the procedure, the child will be allowed to watch videos through virtual reality glasses. Receives: Behavioral: virtual reality applied group |
| control group | No intervention | During the removal and dressing of the wire, the child's attention will be diverted by asking some questions (where she lives, the name of the school she attends, what grade she attends, etc.). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Faces Pain Scale
It is suitable for ages three and above. The pain level of the faces on the scale is explained to the child: "Face 0" indicates that there is no pain and is very happy. "Face 2" has some pain. "Face 4" has slightly more pain. "Face 6" has more pain. The pain of "Face 8" is quite severe. The pain of "Face 10" is unbearable.
Measured: The "Wong-Baker Faces Pain Scale" will be scored 5 minutes before K-wire removal and dressing. It will be evaluated again by scoring the "Wong-Baker Faces Pain Scale" 5 minutes after the K-wire removal and dressing.
Secondary outcomes (1)
Children's Fear Scale
The scale is a scale that evaluates between 0 and 4, consisting of showing five drawn facial expressions ranging from neutral expression (0 = no anxiety) to scared face (4 = severe anxiety).
Measured: "Child Fear Scale" scoring will be done 5 minutes before K-wire removal and dressing. It will be evaluated again by scoring the "Child Fear Scale" 5 minutes after the K-wire removal and dressing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start12 Feb 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra TURAL BUYUK, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246877
- Sponsor's protocol ID
- K Teli
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 9 Feb 2024
- 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 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality on Pain and Fear Level During Kirschner Wires (K-Wires) Removal and Dressing in Children
- ClinicalTrials.gov ID
- NCT06246877
- Acronym / sponsor ID
- K Teli
- Conditions
- Fear of Pain
- Keywords
- child, Kirschner Wires, pain, fear, Virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 12 Feb 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Feb 2024 (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 study will be conducted to examine the effect of virtual reality applied during K-wire removal and dressing on the pain and fear levels that develop due to the procedure in children aged 7-12 years who apply to the orthopedic outpatient clinic.
Detailed description
Technology-based methods have now begun to be used to control anxiety and prevent pain that may occur before, during and after diagnosis and treatment procedures in children.
Virtual reality (VR), which is among the technological products, can be used in non-pharmacological methods as well as pharmacological methods.
It has been observed that VR, especially in children, creates an analgesic effect by mainly distracting the pain centers in the brain and evokes positive emotions with an anxiolytic effect.Since children do not want to see the procedures to be performed on them, virtual reality used during the procedure is one of the methods of diverting attention from the environment they are in. This study will be conducted to examine the effect of virtual reality applied during K-wire removal and dressing on the pain and fear levels that develop due to the procedure in children aged 7-12 years who apply to the orthopedic outpatient clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality applied group | Experimental | Behavioral: virtual reality applied groupBefore the K-wire is removed and dressed, the three-dimensional video that the child likes and wants to watch will be placed on virtual reality glasses and attached to the child. During the procedure, the child will be allowed to watch videos through virtual reality glasses. |
| control group | No intervention | –During the removal and dressing of the wire, the child's attention will be diverted by asking some questions (where she lives, the name of the school she attends, what grade she attends, etc.). |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Being a child between the ages of 7-12 who will have the K wire removed
- The child is not using glasses
- The child must be at a cognitive development level that can respond to video selection.
Key exclusion criteria (4 listed)
- Having a disease that causes chronic pain
- The child must have used medication that would have an analgesic effect in the last 24 hours before the application.
- The child is wearing glasses
- The child has a mental or neurological disability
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 |
|---|---|---|
| virtual reality applied groupBefore the K-wire is removed and dressed, the three-dimensional video that the child likes and wants to watch will be placed on virtual reality glasses and attached to the child. During the procedure, the child will be allowed to watch videos through virtual reality glasses. | Behavioural | virtual reality applied group |
Primary outcome
Wong-Baker Faces Pain Scale
Time frame: The "Wong-Baker Faces Pain Scale" will be scored 5 minutes before K-wire removal and dressing. It will be evaluated again by scoring the "Wong-Baker Faces Pain Scale" 5 minutes after the K-wire removal and dressing.
It is suitable for ages three and above. The pain level of the faces on the scale is explained to the child: "Face 0" indicates that there is no pain and is very happy. "Face 2" has some pain. "Face 4" has slightly more pain. "Face 6" has more pain. The pain of "Face 8" is quite severe. The pain of "Face 10" is unbearable.
1 secondary outcome
Children's Fear Scale
Time frame: "Child Fear Scale" scoring will be done 5 minutes before K-wire removal and dressing. It will be evaluated again by scoring the "Child Fear Scale" 5 minutes after the K-wire removal and dressing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality applied group in people with Fear of Pain, 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 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: status not confirmed, as of the sponsor's last update on 9 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esra TURAL BÜYÜK, pHD (+5052795196, esratural55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong-Baker Faces Pain Scale (time frame: The "Wong-Baker Faces Pain Scale" will be scored 5 minutes before K-wire removal and dressing. It will be evaluated again by scoring the "Wong-Baker Faces Pain Scale" 5 minutes after the K-wire removal and dressing.). 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 9 Feb 2024.