Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05175924 |
| Other study ID # |
Erzi?ncanBinaliYildirim |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2021 |
| Est. completion date |
July 31, 2021 |
Study information
| Verified date |
July 2022 |
| Source |
Erzi?ncan Binali Yildirim Uni?versi?tesi? |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose: The study was carried out to determine the effect of virtual reality applied during
blood collection upon pain and anxiety in children aged 5-12.
Design and Methods: In this randomized controlled study, children included in the sample
group were assigned to the control group (n=43) and Aquarium VR group (n=45) using block
randomization. "Child State Anxiety Scale " and "Wong-Baker Faces Pain Scale" were used to
collect the data of the study. Children in the Aquarium VR group watched the "Aquarium VR"
application through virtual reality glasses during the procedure. The children in the control
group benefited from routine nursing services. The pain scores after blood collection and
anxiety scores before and during blood collection in children in both groups were
interpreted.
Description:
Purpose: The study was carried out to determine the effect of virtual reality applied during
blood collection upon pain and anxiety in children aged 5-12.
MATERIAL AND METHOD Study Design, Participants This study in randomized controlled design was
carried out with children aged between 5-12 in Pediatric Polyclinic blood draw unit of the
University Hospital in a province in Turkey between 15 May and 31 July 2021. The study
population included children who applied to the Pediatrics Polyclinic blood draw unit of the
prespecified hospital between 15 May-31 July 2021. It was calculated by taking into account
the pre-test anxiety score averages of the intervention and control groups in the study of
Gerker et al. (2019) (for the t-test to compare the two groups). As a result of the
evaluations, it was calculated as d=0.99 (high effect size), power=0.95, α=0.05 in the
G*Power 3.1.9.2 statistical program. Accordingly, it was determined that the minimum number
of children to be included in the study was 28 for the intervention group and 28 for the
control group, a total of 56 children. Between these dates, 45 patients were included in the
experimental group and 43 patients in the control group, who met the research criteria and
volunteered to participate in the research, and the study was completed with a total of 88
patients. The study was carried out with children aged 5-12 years, who did not have
communication barriers, did not use glasses, did not have pain before the procedure and did
not have a chronic disease that would cause pain, blood was taken from the antecubital region
and volunteered to participate in the study.
Randomization The children were included in groups randomly. "Stratification and block
randomization methods" were used in the study for assigning the participants to the control
and study groups. It was reported in the literature that the variables of age, gender, and
interventional procedure experience were among the factors affecting the pain and anxiety
experienced by children during interventional procedures. In this sense, the children were
stratified as "female and male" for the gender variable and "5-8 years and 9-12 years" for
the age variable, and block randomization was performed. In order to prevent the groups from
being influenced by each other, data of the study group were collected in one day and the
control group in the other. Data collection days of the study and control groups were
determined with the method of drawing lots. This cycle was continued until sufficient sample
size was obtained.
Data Collection Tools Question Form In this section, there were 6 questions related to the
descriptive characteristics of the children (age, gender, education level of the mother,
education level of the father, time of the last blood draw, the parent's presence with the
child during the blood draw process).
Wong Baker Faces Pain Scale-WBFPS This scale measuring the severity of pain was used in
children aged between 3-18 years. In this scale, pain was scored for facial expressions
according to numerical values, and the numerical rating of the scale varied between 0 and 10.
Facial expressions ranging from smiling (0=very happy/no pain) to crying (10=most painful)
indicated emotions. The severity of pain increased as the score obtained from the scale
increased, and the severity decreased as the score decreased. The child was possible to tell
the nurse about the pain experienced more accurately with the drawing illustrating what each
of the different numbers on the pain scale indicated. This scale was a reliable measurement
tool for the Turkish population (Tsao and Zeltzer, 2008).
Children's State Anxiety Scale (CSAS) CSAS was a thermometer-like scale with a light bulb at
the bottom and horizontal upward lines at intervals. On the scale, the children were
instructed as "Imagine all your anxious or frustrated feelings are in the bulb or bottom of
the thermometer." "If you're a little worried or nervous, emotions can go a little upward on
the thermometer. If you are very, very anxious or nervous, the emotions can go to the top.
Put a line indicating how worried or angry you are on the thermometer." In order to measure
state anxiety (CSAS), the children were asked to mark what they felt "right now". Before
filling in CSAS, sequencing skills of the children were monitored. They were asked to count
to ten, They were also asked to answer, "Which is bigger, seven or four?" The children who
could not successfully complete these tasks or did not understand the instructions were not
asked to fill in CSAS. Subsequent to data collection, two members of the research team
reviewed and scored CSAS of the children. A transparent meter with increments of ½ point
marked was placed above the rating of children, then the increment of ½ point was rounded to
the nearest number. The score varied between 0 and 10 (Gerçeker et al., 2018).
Virtual Reality Headset In the Aquarium VR group, virtual reality headset compatible with
iPhone 7 (Apple) was used to distract attention. Before use, the headsets were tested on five
children for face fit and visibility of the application used. Written and verbal consent of
the children and their parents was obtained to test the headsets. The children who tested the
headsets were not included into the study. The headset offered a soft and comfortable
experience in contact with the skin due to its leather and pad covering. It also had a wide
viewing angle and an optical zoom button. Due to its noise isolation function, it did not
disturb anyone or make noise.
"Aquarium VR" Application The application simulated a submarine journey to explore the inside
of virtual aquarium. The aquarium included sharks, aquatic mammals, clown fish and much more.
It also allowed children to learn more about marine life in the Pacific Ocean (Eon Reality,
2021).
Ethical Principles of the Research In order to carry out the research, 14/03/2021 dated and
03/14 numbered ethics committee approval from the Human Research Ethics Committee and legal
permissions from the Hospital Management were obtained. After informing the children
participating in the study and their parents about the research, they were explained about
being free to participate in or not, and their written and verbal consent was also obtained
from the parents. The children who participated into the study and their parents were assured
that their personal information would not be disclosed to others, would not be used anywhere
else and they had right to withdraw from the study at any time they wanted.
Data Collection The children included into the study and control groups and their families
were primarily informed about the study by the researcher in the waiting room at the entrance
of the pediatric outpatient clinic blood draw unit. The children who were in 5-12 age group,
had no communication barriers, did not use glasses, had no pain before the procedure and did
not have a chronic disease causing pain, and volunteered to participate into the study were
included in the study. The "Informed Consent Form" was signed by the parents and children who
met the criteria and agreed to participate into the study. The children were stratified as
"female and male" for the gender variable and "5-8 years and 9-12 years" for the age
variable, and block randomization was performed.
The children included into the study and control groups and their parents were asked to rate
CSAS to assess their anxiety levels before and during blood draw, and WBFPS to determine the
pain they felt in their arm during blood draw. Similarly, the nurse and researcher rated
WBFPS and CSAS.
The children in the study group were shortly informed about using the virtual reality glasses
before the procedure. When the children sat on the patient's chair for blood draw, they put
on virtual reality glasses and 3D "Aquarium VR" application was started to be watched from
the virtual reality glasses 1 minute before the blood draw procedure. At the same time, the
nurse applied a tourniquet for blood draw from the child and determined the vein from which
blood would be drawn from the antecubital region. The blood was drawn from the antecubital
region by the same nurse by means of a vacuum blood draw tube and the process lasted for
approximately 2-3 minutes. During this procedure, the children were asked not to remove their
virtual reality glasses at all.
No interventional procedure was administered to the children in the control group. Blood was
drawn from the antecubital region by the same nurse by means of a vacutainer. In both groups,
parents were permitted to be with their children in the blood draw room during the procedure.
Data Analysis and Interpretation SPSS 25.0 package software was used for statistical analysis
of the data. Percentage, average, Simple t-test and One Way ANOVA analysis were used to
interpret the data. The statistical level of significance was regarded to be 0.05 in all
tests. In order to obtain statistical results, fit of the data to the normal distribution was
interpreted using the Shao method. In this sense, the Skewness value was determined to be
0.139, the Kurtosis value was -2,027, and it was found to have a normal distribution between
-3 and +3.
