PainNCT04950478
Effect of Virtual Reality on Child Pain
A study testing Virtual Reality in people with Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study is a randomized controlled experimental study conducted to determine effect of using virtual reality headset during venipuncture on pain level, heart rate and oxygen saturation values among 7-12 year-old children. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 30 May 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
- Children aged 7-12 who agreed to participate in the study by giving written and verbal consent,
- Parents who agreed to participate in the study verbally and in written by signing informed consent form,
- Body temperature within normal values for children (36.5- 37.2 oC),
- Children who were healthy and for whom the doctor requested a blood test for general control.
- Children who were healthy in sensory and neurologic aspects.
Who cannot join
- Having any chronic disease or any disease causing pain in children,
- Having hearing, mental or neurological disability in children,
- Having history of syncope during previous venipuncture procedures for the children,
- Having visual impairment in children,
- Unsuccessful venipuncture procedure in the first attempt.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpaşa Florence Nightingale Faculty of Nursing
Istanbul, 34093
About this study
Official title: THE EFFECT OF VIRTUAL REALITY ON PAIN EXPERIENCED BY SCHOOL-AGE CHILDREN DURING VENIPUNCTURE: RANDOMIZED CONTROLLED STUDY
This study is a randomized controlled experimental study conducted to determine effect of using virtual reality headset during venipuncture on pain level, heart rate and oxygen saturation values among 7-12 year-old children. The data were collected from 102 children coming to vaccination room of an university hospital's pediatric outpatient clinic. Before the venipuncture, state anxiety scores of children in both groups were evaluated. The children in experimental group wore virtual reality headset during the venipuncture. The children in control group were subjected to standard venipuncture procedure. Before, during and after the venipuncture, pulse and oxygen saturation values were measured.
Read the detailed description
The research was designed as a randomized controlled experimental study. The population of the study consisted of all 7-12 year-old children who came to a vaccination room of an university hospital's pediatric outpatient clinic .It is stated in the literature that the sample size should be determined as minimum 41 in both experimental and control groups in the experimental studies.
In the study, randomization Urn method was carried out. Urn method consists of two parameters (α and β). These parameters are matched with two different colored balls (red and white). One of the balls was randomly selected and if this ball was white, the individual was assigned to α group; if it was red, then participant was assigned to β group. This process was repeated for each assignment. In the study, white ball was determined as control group; whereas, red ball was determined as experimental group. In the case of a child meeting the sampling criteria, these balls that the researcher had previously prepared were placed in a black bag and any nurse working in the pediatrics outpatient clinic at that time was asked to draw a ball from the bag. The children were assigned to experimental or control group based on color of the selected ball so that they were randomly distributed to two groups. A total of 106 children including 54 children in the experimental group and 52 children in the control group were included in the sample group by taking possible case losses into account. Since 2 children in the experimental group did not want to wear the virtual reality headset during the procedure, they were excluded from the sample. 2 children in the control group were excluded from the sample because venipuncture procedure did not take place at once. Thus, the sample group consisted of 102 children in total including 52 children in the experimental group and 50 children in the control group. The study followed the CONSORT guideline for reporting randomized controlled trials. The data collection questionnaries included a Child and Parent Information Form, State-Trait Anxiety Inventory for Children, and Faces Pain Scale-Revised (FPS-R).
- Conditions
- Pain
- Being tested
- Virtual Reality
- Keywords
- child, nursing, pain management, venipuncture, Virtual reality
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
5 minutes before the procedure, they were recorded on 'Child and Parent Information Form', State-Trait Anxiety Inventory for Children and FPS-R. Their heart rate and oxygen saturation values were read and recorded. Children wore the virtual reality headset and game was started one minute before the venipuncture. As soon as the injector inserted, the researcher turned on a stopwatch and read and recorded heart rate and oxygen saturation values. When the injector was removed, the researcher stopped the stopwatch and recorded the duration of the procedure.When the injector was removed, the stopwatch was stopped and heart rate and oxygen saturation were recorded. The children took off the virtual reality headset and were asked to evaluate their pain level through FPS-R and their responses were recorded.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | The children wore the virtual reality headset and game was started one minute before the venipuncture. The children took off the virtual reality headset after the venipuncture ended. Receives: Other: Virtual Reality |
| Control Group | No intervention | No intervention was performed to reduce pain in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
The children were informed about the Faces Pain Scale-Revised (FPS-R) and they were asked to mark the children's pain levels on the scale before and after the venipuncture procedure. In addition, the pain levels of the children before and after the procedure were determined by the researcher who is a specialist in pediatric nursing by using the same scales.
Measured: Between 5-10 minutes
Secondary outcomes (2)
Heart Rate
Heart rate values were read and recorded form the pulse oximeter before venipuncture, as soon as the injector inserted and after the injector removed.
Measured: Between 5-10 minutes
Oxygen Saturation
Oxygen saturation values were read and recorded form the pulse oximeter before venipuncture, as soon as the injector inserted and after the injector removed.
Measured: Between 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 May 2018
- Primary completion15 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Orhan, Koc University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950478
- Sponsor's protocol ID
- Virtual Reality use on Pain
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Orhan E, Gozen D. The Effect of Virtual Reality on Pain Experienced by School-Age Children During Venipuncture: A Randomized Controlled Study. Games Health J. 2023 Aug;12(4):330-339. doi: 10.1089/g4h.2022.0232.
PubMed 37466456
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF VIRTUAL REALITY ON PAIN EXPERIENCED BY SCHOOL-AGE CHILDREN DURING VENIPUNCTURE: RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT04950478
- Acronym / sponsor ID
- Virtual Reality use on Pain
- Conditions
- Pain
- Keywords
- child, nursing, pain management, venipuncture, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 6 Jul 2021 (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 is a randomized controlled experimental study conducted to determine effect of using virtual reality headset during venipuncture on pain level, heart rate and oxygen saturation values among 7-12 year-old children. The data were collected from 102 children coming to vaccination room of an university hospital's pediatric outpatient clinic. Before the venipuncture, state anxiety scores of children in both groups were evaluated. The children in experimental group wore virtual reality headset during the venipuncture. The children in control group were subjected to standard venipuncture procedure. Before, during and after the venipuncture, pulse and oxygen saturation values were measured.
Detailed description
The research was designed as a randomized controlled experimental study. The population of the study consisted of all 7-12 year-old children who came to a vaccination room of an university hospital's pediatric outpatient clinic .It is stated in the literature that the sample size should be determined as minimum 41 in both experimental and control groups in the experimental studies.
In the study, randomization Urn method was carried out. Urn method consists of two parameters (α and β). These parameters are matched with two different colored balls (red and white). One of the balls was randomly selected and if this ball was white, the individual was assigned to α group; if it was red, then participant was assigned to β group. This process was repeated for each assignment. In the study, white ball was determined as control group; whereas, red ball was determined as experimental group. In the case of a child meeting the sampling criteria, these balls that the researcher had previously prepared were placed in a black bag and any nurse working in the pediatrics outpatient clinic at that time was asked to draw a ball from the bag. The children were assigned to experimental or control group based on color of the selected ball so that they were randomly distributed to two groups. A total of 106 children including 54 children in the experimental group and 52 children in the control group were included in the sample group by taking possible case losses into account. Since 2 children in the experimental group did not want to wear the virtual reality headset during the procedure, they were excluded from the sample. 2 children in the control group were excluded from the sample because venipuncture procedure did not take place at once. Thus, the sample group consisted of 102 children in total including 52 children in the experimental group and 50 children in the control group. The study followed the CONSORT guideline for reporting randomized controlled trials. The data collection questionnaries included a Child and Parent Information Form, State-Trait Anxiety Inventory for Children, and Faces Pain Scale-Revised (FPS-R).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Other: Virtual RealityThe children wore the virtual reality headset and game was started one minute before the venipuncture. The children took off the virtual reality headset after the venipuncture ended. |
| Control Group | No intervention | –No intervention was performed to reduce pain in the control group |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 7-12 who agreed to participate in the study by giving written and verbal consent,
- Parents who agreed to participate in the study verbally and in written by signing informed consent form,
- Body temperature within normal values for children (36.5- 37.2 oC),
- Children who were healthy and for whom the doctor requested a blood test for general control.
- Children who were healthy in sensory and neurologic aspects.
Key exclusion criteria (5 listed)
- Having any chronic disease or any disease causing pain in children,
- Having hearing, mental or neurological disability in children,
- Having history of syncope during previous venipuncture procedures for the children,
- Having visual impairment in children,
- Unsuccessful venipuncture procedure in the first attempt.
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 Reality5 minutes before the procedure, they were recorded on 'Child and Parent Information Form', State-Trait Anxiety Inventory for Children and FPS-R. Their heart rate and oxygen saturation values were read and recorded. Children wore the virtual reality headset and game was started one minute before the venipuncture. As soon as the injector inserted, the researcher turned on a stopwatch and read and recorded heart rate and oxygen saturation values. When the injector was removed, the researcher stopped the stopwatch and recorded the duration of the procedure.When the injector was removed, the stopwatch was stopped and heart rate and oxygen saturation were recorded. The children took off the virtual reality headset and were asked to evaluate their pain level through FPS-R and their responses were recorded. | Other | Virtual Reality |
Primary outcome
Pain Severity
Time frame: Between 5-10 minutes
The children were informed about the Faces Pain Scale-Revised (FPS-R) and they were asked to mark the children's pain levels on the scale before and after the venipuncture procedure. In addition, the pain levels of the children before and after the procedure were determined by the researcher who is a specialist in pediatric nursing by using the same scales.
2 secondary outcomes
Heart Rate
Time frame: Between 5-10 minutes
Oxygen Saturation
Time frame: Between 5-10 minutes
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 Jul 2021.
- Derived from this study: PubMed 37466456Orhan E, Gozen D. The Effect of Virtual Reality on Pain Experienced by School-Age Children During Venipuncture: A Randomized Controlled Study. Games Health J. 2023 Aug;12(4):330-339. doi: 10.1089/g4h.2022.0232.
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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.
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, run by Istanbul University - Cerrahpasa 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 6 Jul 2021. 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?
Pain Severity (time frame: Between 5-10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04950478, which also lists 1 linked publication.
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 Jul 2021.