Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04853056 |
| Other study ID # |
xxx-GOA |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 14, 2020 |
| Est. completion date |
July 14, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Dokuz Eylul University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
