Pain, AcuteNCT05281133
Effect Of Virtual Reality Glasses Used During Splint Application On Children's Pain And Anxiety Levels.
A study testing The group using virtual reality glasses in people with Pain, Acute and Anxiety Acute, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
The study in order to evaluate the effect of virtual reality glasses during splint in children on pain and anxiety due to the procedure. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pain, Acute, Anxiety Acute, Fractures, Bone
- What is being tested?
- The group using virtual reality glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 31 Oct 2021
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child should be between the ages of 6 and 12 age old.
- Acceptance of the research and giving written consent by the family and the child.
- Ability of the family and child to speak Turkish.
- The child should not wear glasses.
- The child should be at a cognitive level able to choose videos.
Who cannot join
- The child should have chronic diseases.
- The child should take analgesics with in the last 24 hours.
- The child should have physical, mental and neurological disabilities.
- The child has a febrile illness.
- Fainting of the child during the procedure.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Institute of Health Sciences Karabuk University
Karabük, Merkez/Turkey, 78050
About this study
The study in order to evaluate the effect of virtual reality glasses during splint in children on pain and anxiety due to the procedure.
Read the detailed description
The study was carried out as a randomized controlled experimental study in order to evaluate the effect of virtual reality glasses during splint in children aged 6-12 years on pain and anxiety due to the procedure.
The sample of the research consisted of 80 childrens who came to Karabuk University Training and Research Hospital orthopedic policlinic and emergency between 1 May and 31 October 2021 for the splint application. In the study, two groups consisted of experimental group (n=40) and control group (n=40) were determined.
The "Participant Information Form", the "Wong Baker Pain Scale", the "State Anxiety Inventory for Children", virtual reality glasses and pulse oximeter were used to collect data. The pain, anxiety and vital signs of the children in the experimental and control groups were recorded before, during and after the splint.
The video chosen by the children in the experimental group was shown with virtual reality glasses during the splint application. In the control group a video wasn't shown during the splint application. Chi square, Mann Whitney U, Bonferroni and Friedman tests were used in the analysis of data.
- Conditions
- Pain, Acute, Anxiety Acute, Fractures, Bone
- Being tested
- The group using virtual reality glasses
- Keywords
- Anxiety, child, fracture, nurse, pain, splint, virtual reality glasses
- Medical subject headings
- Acute Pain, Fractures, Bone, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group using virtual reality glassesOther
The video chosen by the children in the experimental group was started 1-2 minutes before the splint with virtual reality glasses and watched for an average of 7 minutes.
| Study group | Role | What they receive |
|---|---|---|
| The group using virtual reality glasses | Experimental | The video chosen by the children in the experimental group was started 1-2 minutes before the splint with virtual reality glasses and watched for an average of 7 minutes. Receives: Other: The group using virtual reality glasses |
| The group not using virtual reality glasses | No intervention | In the control group, during the splint a video was not watched. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong Baker Pain Scale- (FACES)
Wong Baker Faces Pain Rating Scale was developed by Wong and Baker (1981) and was reorganized in 1983. It is employed in the diagnosis of pain severity in 3e18 years-old children. It includes a zero (0) to five (5) scoring system. It is a horizontal scale of 6 hand-drawn faces, from 0 to 5, that range from a smiling "no hurt" face on the left followed by "hurts little bit", "hurts little more", "hurts even more", "hurts whole lot" to a crying "hurts worst" face on the right and scoring is conducted according to the image.
Measured: six months
State-Trait Anxiety Inventory for Children- (STAI-CH)
State-Trait Anxiety Inventory for Children is the scale developed Spielberg's (1966) for testing anxiety. Children are asked to assess how they feel at the moment and to mark the most appropriate option. For each of the 20 items to evaluate the level of anxiety, one of the options (scored as 1, 2 or 3) is marked according to the presence and severity of the symptom. Turkish adaptation, validity and reliability study of this scale was done by Şeniz Özusta (1993). The scale, which consists of twenty items, aims to evaluate the emotions associated with state anxiety such as tension, nervousness, perturbation, and haste. When the presence of these emotions is reported as "very much so" by the child, the highest score is 3 and the lowest score of 1is assigned when "not at all" is preferred. The highest score in the scale is 60 and the lowest score is 20.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 May 2021
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was carried out as a randomized controlled. In the study, two groups consisted of experimental group (n=40) and control group (n=40) were determined.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağla Kaya, Karabuk University
- Investigators
- Özlem Öztürk Şahin, ass. prof., Study director, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281133
- Sponsor's protocol ID
- KBU-SBE-CK-01
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 16 Mar 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 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Virtual Reality Glasses Used During Splint Application On Children's Pain And Anxiety Levels.
- ClinicalTrials.gov ID
- NCT05281133
- Acronym / sponsor ID
- KBU-SBE-CK-01
- Conditions
- Pain, Acute, Anxiety Acute, Fractures, Bone
- Keywords
- Anxiety, child, fracture, nurse, pain, splint, virtual reality glasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 16 Mar 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 in order to evaluate the effect of virtual reality glasses during splint in children on pain and anxiety due to the procedure.
Detailed description
The study was carried out as a randomized controlled experimental study in order to evaluate the effect of virtual reality glasses during splint in children aged 6-12 years on pain and anxiety due to the procedure.
The sample of the research consisted of 80 childrens who came to Karabuk University Training and Research Hospital orthopedic policlinic and emergency between 1 May and 31 October 2021 for the splint application. In the study, two groups consisted of experimental group (n=40) and control group (n=40) were determined.
The "Participant Information Form", the "Wong Baker Pain Scale", the "State Anxiety Inventory for Children", virtual reality glasses and pulse oximeter were used to collect data. The pain, anxiety and vital signs of the children in the experimental and control groups were recorded before, during and after the splint.
The video chosen by the children in the experimental group was shown with virtual reality glasses during the splint application. In the control group a video wasn't shown during the splint application. Chi square, Mann Whitney U, Bonferroni and Friedman tests were used in the analysis of data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was carried out as a randomized controlled. In the study, two groups consisted of experimental group (n=40) and control group (n=40) were determined.
| Arm | Type | Receives |
|---|---|---|
| The group using virtual reality glasses | Experimental | Other: The group using virtual reality glassesThe video chosen by the children in the experimental group was started 1-2 minutes before the splint with virtual reality glasses and watched for an average of 7 minutes. |
| The group not using virtual reality glasses | No intervention | –In the control group, during the splint a video was not watched. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The child should be between the ages of 6 and 12 age old.
- Acceptance of the research and giving written consent by the family and the child.
- Ability of the family and child to speak Turkish.
- The child should not wear glasses.
- The child should be at a cognitive level able to choose videos.
Key exclusion criteria (5 listed)
- The child should have chronic diseases.
- The child should take analgesics with in the last 24 hours.
- The child should have physical, mental and neurological disabilities.
- The child has a febrile illness.
- Fainting of the child during the procedure.
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 |
|---|---|---|
| The group using virtual reality glassesThe video chosen by the children in the experimental group was started 1-2 minutes before the splint with virtual reality glasses and watched for an average of 7 minutes. | Other | The group using virtual reality glasses |
Primary outcome
Wong Baker Pain Scale- (FACES)
Time frame: six months
Wong Baker Faces Pain Rating Scale was developed by Wong and Baker (1981) and was reorganized in 1983. It is employed in the diagnosis of pain severity in 3e18 years-old children. It includes a zero (0) to five (5) scoring system. It is a horizontal scale of 6 hand-drawn faces, from 0 to 5, that range from a smiling "no hurt" face on the left followed by "hurts little bit", "hurts little more", "hurts even more", "hurts whole lot" to a crying "hurts worst" face on the right and scoring is conducted according to the image.
State-Trait Anxiety Inventory for Children- (STAI-CH)
Time frame: six months
State-Trait Anxiety Inventory for Children is the scale developed Spielberg's (1966) for testing anxiety. Children are asked to assess how they feel at the moment and to mark the most appropriate option. For each of the 20 items to evaluate the level of anxiety, one of the options (scored as 1, 2 or 3) is marked according to the presence and severity of the symptom. Turkish adaptation, validity and reliability study of this scale was done by Şeniz Özusta (1993). The scale, which consists of twenty items, aims to evaluate the emotions associated with state anxiety such as tension, nervousness, perturbation, and haste. When the presence of these emotions is reported as "very much so" by the child, the highest score is 3 and the lowest score of 1is assigned when "not at all" is preferred. The highest score in the scale is 60 and the lowest score is 20.
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 16 Mar 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.
Özlem Öztürk Şahin, ass. prof. study director
Karabuk 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 The group using virtual reality glasses in people with Pain, Acute and Anxiety Acute, run by Karabuk 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 5 inclusion and 5 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 16 Mar 2022. 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?
Wong Baker Pain Scale- (FACES) (time frame: six months). The study lists 2 primary outcomes in all. 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 16 Mar 2022.