Pain, ProceduralNCT05273866
The Effect of Virtual Reality Glasses on Pain on Intravenous Cannulatıon in Children
A study testing Virtual reality in people with Pain, Procedural, run by Nevsehir Haci Bektas Veli University at 1 site in Turkey (Türkiye).
Trial summary
This study was carried out to determine the effect of virtual reality glasses on reducing pain during vascular access in children. The study consisted of 70 children (35 children in the virtual reality video group and 35 children in the control group). Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Procedural
- What is being tested?
- Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Apr 2019to 31 Aug 2019
- 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
- between the ages of 7-12,
- Does not have a disease that causes chronic pain,
- Not taking any analgesic medication in the last 8 hours before the procedure,
- No mental or neurological disability,
- Having no visual or auditory problems that prevent you from applying the scales or watching videos,
- Does not have eye problems and/or does not use glasses to be able to wear VR glasses,
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- The first vascular access procedure was performed during this hospitalization at the clinic,
- Vascular access opened on the first try,
- Speaking and understanding Turkish,
- Children whose parents and themselves agreed to participate in the study were included in the study.
Who cannot join
- Does not understand the Turkish language
- the child is under 7 years old or 12 years older
- having vision, hearing or speech problems
- having a mental or neurological disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Technological Intervention in Pain Control on Intravenous Cannulatıon in Children Virtual Reality Glasses: A Randomized Controlled Study
This study was carried out to determine the effect of virtual reality glasses on reducing pain during vascular access in children. The study consisted of 70 children (35 children in the virtual reality video group and 35 children in the control group). Ethics committee approval, permissions from institutions and informed voluntary consent of the children were obtained in order to conduct the study. The data of the study were collected with Child Descriptive Characteristics Form, Parent Descriptive Characteristics Form, Visual Analog Scale (VAS), Revised Facial Expression Pain Scale (FPS-R), Intervention Monitoring Form, Child Behavior Observation Form and Parent Behavior Observation Form. In the study, the children in the experimental group were shown a video with virtual reality glasses during the vascular access procedure. Before and after the study; The child and his parents were asked to evaluate the pain experienced/will experience during the procedure, the children's heart rate, O2 saturation, body temperature were measured, and the behaviors of the child and the parent during the procedure were evaluated. A p value of <0.05 was considered statistically significant in data analysis.
Read the detailed description
This randomized controlled experimental study was conducted to determine the effect of virtual reality glasses on reducing pain during vascular access in children. The study was conducted among children aged 7-12 years in a tertiary hospital. Children in the experimental group (n=35) and control group (n=35); Age, gender, class of education, previous hospitalization and vascular access experience criteria were selected similar (p>0.05). Data were collected with Child Descriptive Characteristics Form, Parent Descriptive Characteristics Form, Visual Analog Scale (VAS), Revised Facial Expression Pain Scale (FPS-R), Intervention Monitoring Form, Child Behavior Observation Form, and Parent Behavior Observation Form. In the study, the children in the experimental group were shown a video with virtual reality glasses during the vascular access procedure. Before and after the study; The child and his parents were asked to evaluate the pain experienced/will experience during the procedure, the children's heart rate, O2 saturation, body temperature were measured, and the behaviors of the child and the parent during the procedure were evaluated. Data were used post-power analysis, descriptive statistics, Shapiro Wilk, Pearson chi-square, Mann Whitney U and Two-Related-Samples Tests. A p value of <0.05 was considered statistically significant in data analysis.
- Conditions
- Pain, Procedural
- Being tested
- Virtual reality
- Keywords
- distraction, intravenous cannulation, pain, school-aged children, virtual reality glasses
- Medical subject headings
- Pain, Procedural, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
Virtual Reality video application reduces pain by distracting. The intervention group was watched video during the procedure, starting before the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Virtual reality video application Receives: Other: Virtual reality |
| control group | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS), Change:
The severity of the pain marked by the child on the scale ranges from 0 to 10. If the severity increases after the procedure, it indicates that the pain increases, and if it decreases, it indicates that the pain decreases.
Measured: 2 minutes before and 2 minutes after Intravenous Cannulatıon
Faces Pain Scale-Revised (FPS-R), Change:
In the scale consisting of facial expressions, each facial expression has a number equivalent. The severity of pain marked by the child on the scale ranges from 0 to 10. If the severity increases after the procedure, it indicates that the pain increases, and if it decreases, it indicates that the pain decreases.
Measured: 3 minutes before and 3 minutes after Intravenous Cannulatıon
Secondary outcomes (2)
Physiological parameters
Heart Rate, Change
Measured: 2 minutes before and 2 minutes after Intravenous Cannulatıon
Physiological parameters
Oxygen saturation, Change
Measured: 3 minutes before and 3 minutes after Intravenous Cannulatıon
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start29 Apr 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ProceduralStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevsehir Haci Bektas Veli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahriye Kaplan, Nevsehir Haci Bektas Veli University
- Investigators
- Bahriye Kaplan, Doctor, Study director, Nevsehir Haci Bektas Veli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273866
- Sponsor's protocol ID
- 84902927
- Status last verified
- Mar 2022
- First submitted
- 8 Feb 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Technological Intervention in Pain Control on Intravenous Cannulatıon in Children Virtual Reality Glasses: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05273866
- Acronym / sponsor ID
- 84902927
- Conditions
- Pain, Procedural
- Keywords
- distraction, intravenous cannulation, pain, school-aged children, virtual reality glasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Nevsehir Haci Bektas Veli UniversityUniversity, hospital or other
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 10 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.
This study was carried out to determine the effect of virtual reality glasses on reducing pain during vascular access in children. The study consisted of 70 children (35 children in the virtual reality video group and 35 children in the control group). Ethics committee approval, permissions from institutions and informed voluntary consent of the children were obtained in order to conduct the study. The data of the study were collected with Child Descriptive Characteristics Form, Parent Descriptive Characteristics Form, Visual Analog Scale (VAS), Revised Facial Expression Pain Scale (FPS-R), Intervention Monitoring Form, Child Behavior Observation Form and Parent Behavior Observation Form. In the study, the children in the experimental group were shown a video with virtual reality glasses during the vascular access procedure. Before and after the study; The child and his parents were asked to evaluate the pain experienced/will experience during the procedure, the children's heart rate, O2 saturation, body temperature were measured, and the behaviors of the child and the parent during the procedure were evaluated. A p value of <0.05 was considered statistically significant in data analysis.
Detailed description
This randomized controlled experimental study was conducted to determine the effect of virtual reality glasses on reducing pain during vascular access in children. The study was conducted among children aged 7-12 years in a tertiary hospital. Children in the experimental group (n=35) and control group (n=35); Age, gender, class of education, previous hospitalization and vascular access experience criteria were selected similar (p>0.05). Data were collected with Child Descriptive Characteristics Form, Parent Descriptive Characteristics Form, Visual Analog Scale (VAS), Revised Facial Expression Pain Scale (FPS-R), Intervention Monitoring Form, Child Behavior Observation Form, and Parent Behavior Observation Form. In the study, the children in the experimental group were shown a video with virtual reality glasses during the vascular access procedure. Before and after the study; The child and his parents were asked to evaluate the pain experienced/will experience during the procedure, the children's heart rate, O2 saturation, body temperature were measured, and the behaviors of the child and the parent during the procedure were evaluated. Data were used post-power analysis, descriptive statistics, Shapiro Wilk, Pearson chi-square, Mann Whitney U and Two-Related-Samples Tests. A p value of <0.05 was considered statistically significant in data analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Other: Virtual realityVirtual reality video application |
| control group | No intervention | –control group |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- between the ages of 7-12,
- Does not have a disease that causes chronic pain,
- Not taking any analgesic medication in the last 8 hours before the procedure,
- No mental or neurological disability,
- Having no visual or auditory problems that prevent you from applying the scales or watching videos,
Key exclusion criteria (4 listed)
- Does not understand the Turkish language
- the child is under 7 years old or 12 years older
- having vision, hearing or speech problems
- having 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 realityVirtual Reality video application reduces pain by distracting. The intervention group was watched video during the procedure, starting before the procedure. | Other | Virtual reality |
Primary outcome
Visual Analog Scale (VAS), Change:
Time frame: 2 minutes before and 2 minutes after Intravenous Cannulatıon
The severity of the pain marked by the child on the scale ranges from 0 to 10. If the severity increases after the procedure, it indicates that the pain increases, and if it decreases, it indicates that the pain decreases.
Faces Pain Scale-Revised (FPS-R), Change:
Time frame: 3 minutes before and 3 minutes after Intravenous Cannulatıon
In the scale consisting of facial expressions, each facial expression has a number equivalent. The severity of pain marked by the child on the scale ranges from 0 to 10. If the severity increases after the procedure, it indicates that the pain increases, and if it decreases, it indicates that the pain decreases.
2 secondary outcomes
Physiological parameters
Time frame: 2 minutes before and 2 minutes after Intravenous Cannulatıon
Physiological parameters
Time frame: 3 minutes before and 3 minutes after Intravenous Cannulatıon
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 10 Mar 2022.
- 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.
Bahriye Kaplan, Doctor study director
Nevsehir Haci Bektas Veli 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 Virtual reality in people with Pain, Procedural, run by Nevsehir Haci Bektas Veli 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 10 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: finished, as of the sponsor's last update on 10 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?
Visual Analog Scale (VAS), Change: (time frame: 2 minutes before and 2 minutes after Intravenous Cannulatıon). 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 10 Mar 2022.