PainIVVRBuzzyNCT04853056
Virtual-Reality and Cold-Vibration Device on Procedure-Related Fear, Anxiety and Pain During Pediatric IV Line Placement
A study testing virtual reality and Cold vibration in people with Pain and Fear, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Studies evaluating VR are quite insufficient. In the study we determined in the emergency room between the ages of 4-10, cold vibration and virtual reality will be compared, and the success of the first attempt, pain, fear and anxiety will be evaluated. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- What is being tested?
- virtual reality and Cold vibration
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Dec 2020to 14 Jul 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 4-10
- The child agrees to voluntarily participate in the study.
- Parents agree to voluntarily participate in the study
- Obtaining consent form from the child and parent
Who cannot join
- - The child with physical and psychological deficit to prevent him from wearing the glasses to be worn on his head so that he can watch virtual reality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality and Cold Vibration Device on First Attempt Success, Procedure-Related Fear, Anxiety and Pain During Pediatric Intravenous Line Placement in Children Between 4-10 Years Old in the Emergency Department
Studies evaluating VR are quite insufficient. In the study we determined in the emergency room between the ages of 4-10, cold vibration and virtual reality will be compared, and the success of the first attempt, pain, fear and anxiety will be evaluated.
Read the detailed description
It was planned to evaluate the effect of virtual reality, cold vibration device application on the first attempt success, procedure-related pain, fear and anxiety during pediatric intravenous line placement in children aged 4-10 years in the pediatric emergency unit.
H1: Patients who watch videos with virtual reality glasses or who are applied cold vibration device during the vascular access procedure have a high first-attempt success.
H2: The pain, fear, and anxiety scores of the patients who watch videos with virtual reality glasses or who are applied cold vibration device during the venipuncture procedure are lower.
It is planned to include children between the ages of 4 and 10 who will be given vascular access in the Dokuz Eylül University Pediatric Emergency Unit. Between December 2020 and January 2021, it is planned to include patients selected by stratified randomization method in accordance with the sampling criteria. In the Gpower statistical program, based on the results of one-way variance analysis used in the comparison of pain and anxiety scores in the study of Canbulat et al. It was determined that a sample was required. In the study, it was planned to fulfill the parametric test assumptions and to have 50 children for each group and 150 children for the total sample, considering 10% loss.
Inclusion / exclusion criteria in the study:
- Children between the ages of 4-10
- The child agrees to voluntarily participate in the study.
- Parents agree to voluntarily participate in the study
- Obtaining consent form from the child and parent
- The child does not have a physical and psychological deficit to prevent him from wearing the glasses to be worn on his head so that he can watch virtual reality.
Patients who will be peripheral IV line accessed will be allocated to the groups according to randomization. The child and parents will be informed and after their consent, the group they belong to will be determined. No additional intervention will be made to the patient in the control group and will be observed during the procedure after obtaining her consent.
Standard approach will be applied to all pediatric patients. Standard approach; Providing information about the procedure, introducing the nurse himself, choosing the region together, being with the parent and talking to the child during the procedure. No additional intervention will be made to the patient in the control group, and until the intervention begins, "How old are you? Which grade are you in? What is the name of your favorite friend? Which sport do you like better? " Attention will be distracted by asking questions such as.
By introducing a virtual headset to the selected child to the video monitoring initiative group with virtual glasses, it will be said that he can watch videos by wearing the virtual headset during the procedure (Figure 1). The video he wants to watch together will be determined. If virtual glasses are desired to be removed during the procedure, the child will be excluded from the study. One of the 3 interesting videos will be determined by the researchers, with the preference of the child.
In the cold vibration group, bee Buzzy will be attached to the arm where the nurse will perform the peripheral IV line access. Bee Buzzy confuses nerves and reduces pain thanks to its cold wings and vibration. help distract attention during the injection period, reduce the feeling of pain and fear. Buzzy will be tied 5 cm above the area where blood will be taken, and after waiting 15 seconds, vascular access will be opened by the nurse. It will be wiped with disinfectant before and after the intervention.
After each patient included in the study is taken to the chair where the intervention will be performed (the starting hour/minute of the procedure will be recorded), the patient will be monitored and pulse, respiration, and blood pressure will be measured. The child will be evaluated by the nurse before the procedure with the Emotional Appearance Scale for Children.
The patient's pulse, respiration, blood pressure will be measured again (minutes will be recorded). Pulse, respiration and blood pressure will be re-evaluated at the 5th minute of the beginning of the procedure. At the 5th minute of the procedure, the child will be asked to evaluate the most painful moment he feels during the procedure with a Facial Expressions Rating Scale and a Color Analog Scale. The child will be given the Child Fear Scale (CFS) and the Child Anxiety Scale-State to evaluate how anxious and afraid he or she is during the procedure. You will be asked to mark it with a pencil.
Research data will be collected by the following data collection forms:
Socio-Demographic Data Collection Form Procedure Follow-up Form Pain scale Fear Scale Child Anxiety Scale-State Emotional Appearance Scale for Children
Socio-Demographic Data Collection Form: The Socio-demographic Data Collection Form consists of questions about the sociodemographic characteristics of the children and parents who will participate in the study. Sociodemographic features; It includes "age, gender, diagnosis, date of last bloodletting" regarding the child, and "age, closeness to the child, educational status, number of children" for the parent.
Procedure Follow-up Form: The child's difficult vascular access intervention score, procedure initiation time, vital signs, and first attempt success will be recorded.
Wong-Baker FACES (WBS) Pain Rating Scale. This scale uses in children aged 3 and older to rate pain severity, ranges from 0 (very happy/no pain) to 10 (hurts worst).
The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater response indicates the level of fear. It can be used during the procedure for children aged 5-10 years.
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety.
Emotional Appearance Scale for Children: This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. Higher scale score indicates the appearance of more negative emotional behaviors.
- Conditions
- Pain, Fear, Anxiety, Child, Only
- Being tested
- virtual reality, Cold vibration
- 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 realityDevice
Also called distraction methods
wearing virtual reality glasses
Cold vibrationDevice
Also called distraction methods
Buzzy
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | watching the application by wearing virtual glasses to the child during the peripheral IV line insertion Receives: Device: virtual reality |
| Cold Vibration Group | Experimental | Buzzy, connecting and operating 5 cm above the area to be inserted peripheral IV line Receives: Device: Cold vibration |
| Control group | No intervention | Standart care |
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).
Measured: during the procedure
Anxiety assesed by Children Anxiety Meter-State
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety
Measured: during the procedure
Fear assesed by Child Fear Scale
The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear. It can be used during the procedure for children aged 5-10 years.
Measured: during the procedure
Secondary outcomes (1)
Emotional Appearance Scale for Children
This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. Higher scale score indicates the appearance of more negative emotional behaviors
Measured: Baseline (before the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start14 Dec 2020
- Primary completion14 Jun 2021
- Study completion14 Jul 2021
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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
- Investigators
- Gülçin Özalp Gerçeker, Principal investigator, RN, PhD, Assoc. Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853056
- Sponsor's protocol ID
- xxx-GOA
- Acronym
- IVVRBuzzy
- Status last verified
- Feb 2022
- First submitted
- 16 Apr 2021
- Last updated
- 10 Feb 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 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality and Cold Vibration Device on First Attempt Success, Procedure-Related Fear, Anxiety and Pain During Pediatric Intravenous Line Placement in Children Between 4-10 Years Old in the Emergency Department
- ClinicalTrials.gov ID
- NCT04853056
- Acronym / sponsor ID
- IVVRBuzzy / xxx-GOA
- Conditions
- Pain, Fear, Anxiety, Child, Only
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 21 Apr 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.
Studies evaluating VR are quite insufficient. In the study we determined in the emergency room between the ages of 4-10, cold vibration and virtual reality will be compared, and the success of the first attempt, pain, fear and anxiety will be evaluated.
Detailed description
It was planned to evaluate the effect of virtual reality, cold vibration device application on the first attempt success, procedure-related pain, fear and anxiety during pediatric intravenous line placement in children aged 4-10 years in the pediatric emergency unit.
H1: Patients who watch videos with virtual reality glasses or who are applied cold vibration device during the vascular access procedure have a high first-attempt success.
H2: The pain, fear, and anxiety scores of the patients who watch videos with virtual reality glasses or who are applied cold vibration device during the venipuncture procedure are lower.
It is planned to include children between the ages of 4 and 10 who will be given vascular access in the Dokuz Eylül University Pediatric Emergency Unit. Between December 2020 and January 2021, it is planned to include patients selected by stratified randomization method in accordance with the sampling criteria. In the Gpower statistical program, based on the results of one-way variance analysis used in the comparison of pain and anxiety scores in the study of Canbulat et al. It was determined that a sample was required. In the study, it was planned to fulfill the parametric test assumptions and to have 50 children for each group and 150 children for the total sample, considering 10% loss.
Inclusion / exclusion criteria in the study:
- Children between the ages of 4-10
- The child agrees to voluntarily participate in the study.
- Parents agree to voluntarily participate in the study
- Obtaining consent form from the child and parent
- The child does not have a physical and psychological deficit to prevent him from wearing the glasses to be worn on his head so that he can watch virtual reality.
Patients who will be peripheral IV line accessed will be allocated to the groups according to randomization. The child and parents will be informed and after their consent, the group they belong to will be determined. No additional intervention will be made to the patient in the control group and will be observed during the procedure after obtaining her consent.
Standard approach will be applied to all pediatric patients. Standard approach; Providing information about the procedure, introducing the nurse himself, choosing the region together, being with the parent and talking to the child during the procedure. No additional intervention will be made to the patient in the control group, and until the intervention begins, "How old are you? Which grade are you in? What is the name of your favorite friend? Which sport do you like better? " Attention will be distracted by asking questions such as.
By introducing a virtual headset to the selected child to the video monitoring initiative group with virtual glasses, it will be said that he can watch videos by wearing the virtual headset during the procedure (Figure 1). The video he wants to watch together will be determined. If virtual glasses are desired to be removed during the procedure, the child will be excluded from the study. One of the 3 interesting videos will be determined by the researchers, with the preference of the child.
In the cold vibration group, bee Buzzy will be attached to the arm where the nurse will perform the peripheral IV line access. Bee Buzzy confuses nerves and reduces pain thanks to its cold wings and vibration. help distract attention during the injection period, reduce the feeling of pain and fear. Buzzy will be tied 5 cm above the area where blood will be taken, and after waiting 15 seconds, vascular access will be opened by the nurse. It will be wiped with disinfectant before and after the intervention.
After each patient included in the study is taken to the chair where the intervention will be performed (the starting hour/minute of the procedure will be recorded), the patient will be monitored and pulse, respiration, and blood pressure will be measured. The child will be evaluated by the nurse before the procedure with the Emotional Appearance Scale for Children.
The patient's pulse, respiration, blood pressure will be measured again (minutes will be recorded). Pulse, respiration and blood pressure will be re-evaluated at the 5th minute of the beginning of the procedure. At the 5th minute of the procedure, the child will be asked to evaluate the most painful moment he feels during the procedure with a Facial Expressions Rating Scale and a Color Analog Scale. The child will be given the Child Fear Scale (CFS) and the Child Anxiety Scale-State to evaluate how anxious and afraid he or she is during the procedure. You will be asked to mark it with a pencil.
Research data will be collected by the following data collection forms:
Socio-Demographic Data Collection Form Procedure Follow-up Form Pain scale Fear Scale Child Anxiety Scale-State Emotional Appearance Scale for Children
Socio-Demographic Data Collection Form: The Socio-demographic Data Collection Form consists of questions about the sociodemographic characteristics of the children and parents who will participate in the study. Sociodemographic features; It includes "age, gender, diagnosis, date of last bloodletting" regarding the child, and "age, closeness to the child, educational status, number of children" for the parent.
Procedure Follow-up Form: The child's difficult vascular access intervention score, procedure initiation time, vital signs, and first attempt success will be recorded.
Wong-Baker FACES (WBS) Pain Rating Scale. This scale uses in children aged 3 and older to rate pain severity, ranges from 0 (very happy/no pain) to 10 (hurts worst).
The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater response indicates the level of fear. It can be used during the procedure for children aged 5-10 years.
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety.
Emotional Appearance Scale for Children: This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. Higher scale score indicates the appearance of more negative emotional behaviors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: virtual realitywatching the application by wearing virtual glasses to the child during the peripheral IV line insertion |
| Cold Vibration Group | Experimental | Device: Cold vibrationBuzzy, connecting and operating 5 cm above the area to be inserted peripheral IV line |
| Control group | No intervention | –Standart care |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children between the ages of 4-10
- The child agrees to voluntarily participate in the study.
- Parents agree to voluntarily participate in the study
- Obtaining consent form from the child and parent
Key exclusion criteria (1 listed)
- - The child with physical and psychological deficit to prevent him from wearing the glasses to be worn on his head so that he can watch virtual reality.
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 realityAlso: distraction methodswearing virtual reality glasses | Device | Virtual Reality Group |
| Cold vibrationAlso: distraction methodsBuzzy | Device | Cold Vibration Group |
Primary outcome
Pain assesed by Wong-Baker FACES
Time frame: during the 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).
Anxiety assesed by Children Anxiety Meter-State
Time frame: during the procedure
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety
Fear assesed by Child Fear Scale
Time frame: during the procedure
The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear. It can be used during the procedure for children aged 5-10 years.
1 secondary outcome
Emotional Appearance Scale for Children
Time frame: Baseline (before the 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 10 Feb 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.
Gülçin Özalp Gerçeker principal investigator
RN, PhD, Assoc. Prof.
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 Cold vibration in people with Pain and Fear, run by Dokuz Eylul 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 4 inclusion and 1 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 Feb 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?
Pain assesed by Wong-Baker FACES (time frame: during the procedure). The study lists 3 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 Feb 2022.