PainNCT05588687
The Effect of Two Distraction Methods on the Level of Pain, Fear and Anxiety in Children
A study testing Virtual reality and Tablet in people with Pain and Anxiety, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of watching cartoons with virtual reality glasses and tablets applied during the blood collection process on the level of pain, fear and anxiety experienced by children. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- What is being tested?
- Virtual reality and Tablet
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Jun 2022
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child and family agree to participate in the research,
- The child is between the ages of 5-12
- The child does not have a chronic and mental health problem.
- Not having a visual and hearing disability
- No history of sedative, analgesic or narcotic substance use within 24 hours before admission
- Not having a febrile illness at the time of application
Show all 9Show fewer
- Absence of a disease causing chronic pain
- Being treated in the green area according to the 3-level (red-yellow-green) triage system.
- Performing the operation at once
Who cannot join
- • The child and family's refusal to participate in the research
- Having a visual and auditory problem
- The child is less than 5 years old or older than 12 years old
- The child has a chronic and mental health problem
- Being treated in the red or yellow area according to the 3-level (red-yellow-green) triage system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Two Different Distraction Methods Applied During Venous Blood Collection Procedure on the Level of Pain, Fear and Anxiety in Pediatric Emergency Department
The aim of this study is to determine the effect of watching cartoons with virtual reality glasses and tablets applied during the blood collection process on the level of pain, fear and anxiety experienced by children.
Read the detailed description
Needle procedures applied to children for diagnosis and treatment cause fear, anxiety, and pain. In cases where children's pain and fear cannot be controlled, health professionals and parents may experience feelings of stress, helplessness, and guilt. Many approaches reduce pain and anxiety in children during painful procedures. The most commonly used of these approaches is the distraction technique, also known as the distraction technique, which is constructed with cognitive and behavioral processes. There are many methods used to divert attention. Some of those; watching cartoons, inflating balloons, creating balloons by blowing foam, directing techniques, parent coaching, using virtual reality (VR) glasses, listening to music, kaleidoscope, and using distraction cards. The research is a randomized controlled experimental study designed to determine the effects of two different methods (watching 360-degree cartoons with virtual reality glasses and watching cartoons with a tablet) during the blood collection procedure in children, on the level of pain, fear, and anxiety experienced by children.
- Conditions
- Pain, Anxiety, Fear, Venipuncture Site Reaction, Nursing Caries
- Being tested
- Virtual reality, Tablet
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityBehavioural
Children will watch Ice Age in virtual reality during blood draw and the researcher will monitor their pain, anxiety and fear.
TabletDevice
Children will watch Ice Age with a tablet during blood draw and the researcher will monitor their pain, anxiety and fear.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Children in the control group will be received standard care. Control group children will not receive any distraction techniques. |
| Virtual reality group | Experimental | The children in the VR groups will watch the video by wearing virtual glasses during the blood draw. By wearing the VR headsets in the VR-Rollercoaster Group, will watch Ice Age. Receives: Behavioral: Virtual reality |
| Tablet group | Experimental | The children in the tablet groups will watch the video during the blood draw with tablet. They will watch Ice Age. Receives: Device: Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assesed by Wong-Baker FACES
Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst). This scale was assessed using self-report and reports from the parents, the researcher and the nurse who attempted the blood draw after the blood draw procedure in this study.
Measured: 1 minute before the blood draw procedure
Pain assesed by Wong-Baker FACES
Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst). This scale was assessed using self-report and reports from the parents, the researcher and the nurse who attempted the blood draw after the blood draw procedure in this study.
Measured: 1 minute after the blood draw procedure
Procedure Related Fear
The Child Fear Scale (CFS) used. This scale is a one-item self-report measure for measuring pain-related fear in children. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. It can be used by the parents and researchers before and during the procedure for children aged 5-10 years.CFS were administered by the researcher to the children to assess their fear levels about blood draw before and after blood draw procedure.
Measured: 1 minute before the blood draw procedure
Procedure Related Fear
The Child Fear Scale (CFS) used. This scale is a one-item self-report measure for measuring pain-related fear in children. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. It can be used by the parents and researchers before and during the procedure for children aged 5-10 years.CFS were administered by the researcher to the children to assess their fear levels about blood draw before and after blood draw procedure.
Measured: 1 minute after the blood draw procedure
Procedure Related Anxiety
The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety (CAM-S). (Kleiber \& Mccarthy, 2006). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.CAM were administered by the researcher to the children to assess their anxiety levels about blood draw before and after the blood draw procedure.
Measured: 1 minute before the blood draw procedure
Procedure Related Anxiety
The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety (CAM-S). (Kleiber \& Mccarthy, 2006). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.CAM were administered by the researcher to the children to assess their anxiety levels about blood draw before and after the blood draw procedure.
Measured: 1 minute after the blood draw procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Feb 2022
- Primary completion1 May 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Parallel groups
- Model description
- This study is an experimental, parallel-group (intervention-control), randomized controlled design
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remziye Semerci, Trakya University
- Investigators
- Remziye Semerci, PhD, Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588687
- Sponsor's protocol ID
- Koç University
- Status last verified
- Apr 2023
- First submitted
- 30 Aug 2022
- Last updated
- 11 Apr 2023
- 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 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Distraction Methods Applied During Venous Blood Collection Procedure on the Level of Pain, Fear and Anxiety in Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT05588687
- Acronym / sponsor ID
- Koç University
- Conditions
- Pain, Anxiety, Fear, Venipuncture Site Reaction, Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 20 Oct 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 aim of this study is to determine the effect of watching cartoons with virtual reality glasses and tablets applied during the blood collection process on the level of pain, fear and anxiety experienced by children.
Detailed description
Needle procedures applied to children for diagnosis and treatment cause fear, anxiety, and pain. In cases where children's pain and fear cannot be controlled, health professionals and parents may experience feelings of stress, helplessness, and guilt. Many approaches reduce pain and anxiety in children during painful procedures. The most commonly used of these approaches is the distraction technique, also known as the distraction technique, which is constructed with cognitive and behavioral processes. There are many methods used to divert attention. Some of those; watching cartoons, inflating balloons, creating balloons by blowing foam, directing techniques, parent coaching, using virtual reality (VR) glasses, listening to music, kaleidoscope, and using distraction cards. The research is a randomized controlled experimental study designed to determine the effects of two different methods (watching 360-degree cartoons with virtual reality glasses and watching cartoons with a tablet) during the blood collection procedure in children, on the level of pain, fear, and anxiety experienced by children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is an experimental, parallel-group (intervention-control), randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Children in the control group will be received standard care. Control group children will not receive any distraction techniques. |
| Virtual reality group | Experimental | Behavioral: Virtual realityThe children in the VR groups will watch the video by wearing virtual glasses during the blood draw. By wearing the VR headsets in the VR-Rollercoaster Group, will watch Ice Age. |
| Tablet group | Experimental | Device: TabletThe children in the tablet groups will watch the video during the blood draw with tablet. They will watch Ice Age. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- The child and family agree to participate in the research,
- The child is between the ages of 5-12
- The child does not have a chronic and mental health problem.
- Not having a visual and hearing disability
- No history of sedative, analgesic or narcotic substance use within 24 hours before admission
Key exclusion criteria (5 listed)
- • The child and family's refusal to participate in the research
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 realityChildren will watch Ice Age in virtual reality during blood draw and the researcher will monitor their pain, anxiety and fear. | Behavioural | Virtual reality group |
| TabletChildren will watch Ice Age with a tablet during blood draw and the researcher will monitor their pain, anxiety and fear. | Device | Tablet group |
Primary outcome
Pain assesed by Wong-Baker FACES
Time frame: 1 minute before the blood draw procedure
Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst). This scale was assessed using self-report and reports from the parents, the researcher and the nurse who attempted the blood draw after the blood draw procedure in this study.
Pain assesed by Wong-Baker FACES
Time frame: 1 minute after the blood draw procedure
Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst). This scale was assessed using self-report and reports from the parents, the researcher and the nurse who attempted the blood draw after the blood draw procedure in this study.
Procedure Related Fear
Time frame: 1 minute before the blood draw procedure
The Child Fear Scale (CFS) used. This scale is a one-item self-report measure for measuring pain-related fear in children. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. It can be used by the parents and researchers before and during the procedure for children aged 5-10 years.CFS were administered by the researcher to the children to assess their fear levels about blood draw before and after blood draw procedure.
Procedure Related Fear
Time frame: 1 minute after the blood draw procedure
The Child Fear Scale (CFS) used. This scale is a one-item self-report measure for measuring pain-related fear in children. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. It can be used by the parents and researchers before and during the procedure for children aged 5-10 years.CFS were administered by the researcher to the children to assess their fear levels about blood draw before and after blood draw procedure.
Procedure Related Anxiety
Time frame: 1 minute before the blood draw procedure
The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety (CAM-S). (Kleiber \& Mccarthy, 2006). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.CAM were administered by the researcher to the children to assess their anxiety levels about blood draw before and after the blood draw procedure.
Procedure Related Anxiety
Time frame: 1 minute after the blood draw procedure
The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety (CAM-S). (Kleiber \& Mccarthy, 2006). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.CAM were administered by the researcher to the children to assess their anxiety levels about blood draw before and after the blood draw procedure.
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 11 Apr 2023.
- 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.
Remziye Semerci, PhD principal investigator
Koç 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 and Tablet in people with Pain and Anxiety, run by Trakya 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 9 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 11 Apr 2023. 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 assesed by Wong-Baker FACES (time frame: 1 minute before the blood draw procedure). The study lists 6 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 11 Apr 2023.