Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05401539 |
| Other study ID # |
MCBU-KARAARSLAN |
| Secondary ID |
2020-083 |
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2022 |
| Est. completion date |
December 30, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Celal Bayar University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Experiences such as hospitalization, medical or surgical procedures are stressful, complex
and threatening, especially for children and their families. Among the first crisis symptoms
that children are faced with are illness, hospitalization and surgery anxiety. There is a
direct relationship between the fear and anxiety experienced by children and their parents
during the pre-operative processes. Therefore, ensuring not only the psychological but also
physiological preparation of both the children and their parents before the surgery is of
great importance. In the hospital, applying distraction methods appropriate for the age
period of children and conveying procedural information to them simultaneously are difficult
and challenging. In such situations, in clinical settings, virtual reality technology can be
used at any time and place without requiring extra workforce to eliminate or reduce
children's fear and anxiety. Virtual reality applications, as a distracting therapeutic
method, are a fun, calming, safe, accessible, effective and acceptable intervention that can
be used for the management of acute pain, fear and anxiety in pediatric patients. Such
applications can affect children visually, aurally and contextually. Because they are
different from common distraction methods used by children such as reading books, playing
with toys, watching television or movies, playing a two-dimensional video game or game
console. Virtual reality (VR) is used to distract children's attention to reduce fear and
anxiety before surgery. A VR tour of the operating theater can provide a realistic experience
for children. The aim in this study was to investigate the effect of an actual operating
theater tour which is watched by children aged 6-12 years wearing a 3D virtual headset on
their fear and anxiety.
Description:
For school-age children aged 6-12, hospitalization and surgery mean a process full of worries
causing anxiety and fear. In the preoperative period, children may feel threatened by being
in an unfamiliar environment, seeing unfamiliar faces with masks, hearing the alarm sounds of
devices, being exposed to medical procedures, and experiencing parental separation and
parental anxiety. Preoperative anxiety is an important issue in pediatric patients because
postoperative anxiety is related to preoperative anxiety and anxiety experienced at the
beginning of anesthesia. The success of the surgery in children is related not only to the
importance of the techniques and skills applied but also to the pre-operative preparation of
children and meeting their and their parents' care needs. Therefore, preparing the child for
the operation appropriately, being aware of the causes of anxiety and taking preventive
measures in the preoperative period are very important for the physiological health of
children and their parents. If the child is prepared for the operation in accordance with the
procedures in the pre-operative period, it prevents the child from experiencing behavioral
and physiological symptoms of anxiety. In children who are psychologically affected in the
postoperative period, maladaptive behavioral changes such as anxiety, eating and sleep
disorders, nightmares, enuresis, and tantrums are observed during the preoperative period. As
observed in several studies, children whose anxiety levels are high in the preoperative
period experience more complications during the postoperative recovery period. In addition,
such anxiety experienced by children in the preoperative period causes them to stay in
hospitals for a longer time (prolongs their hospitalization) in the postoperative period,
which increases the burden and costs of health care significantly. In a study, it was
observed that distracting 4-10-year old children's attention with tablets and phones in the
pre-operative period decreased their stress and postoperative delirium, and anxiety
experienced by their parents, and increased their cooperation with health personnel during
the induction of anesthesia. Therefore, relieving preoperative anxiety not with
pharmacological methods with side effects and potential risks but with non-pharmacological
methods is of great importance.The use of non-pharmacological methods in children has been
determined to be effective and safe. When which approach is to be applied to children is
decided, the child's age, cognitive status, coping mechanisms, skills to keep up with digital
age and use the technology should be taken into consideration because today's digital
technology not only affects the whole world but also affects and changes the lives of
children. Educational multimedia applications, web-based programs, visual and auditory
technological tools are used to reduce children's preoperative anxiety and to create a more
enjoyable experience by distracting their attention. With the latest developments in
technology, lively, immersive and virtual reality systems have been included in the
pre-operative preparation training of especially pediatric patients. Virtual reality
technology enables children and their parents to be acquainted with the physical environment
such as the operating theatre and recovery area in hospital environments they have not been
in previously. A virtual reality tour, which is shown to children in the operating theatre
before they undergo anesthesia, enables them to have a realistic, actual and inexpensive
experience.Two mechanisms explaining the effect of virtual reality on anxiety are described
as "exposure to the environment" and "distraction".Recent studies conducted on this issue
show that virtual reality, an immersive technology, is an effective intervention to reduce
preoperative anxiety in children. In randomized control studies conducted to determine
children's preoperative anxiety levels, it was determined that the anxiety levels of children
who used virtual reality technology were significantly lower than were those who of children
did not use such technology. Preparing the child psychologically and eliminating his or her
fear and anxiety in the pre-operative period will reduce the amount of anesthesia during the
operation and that of analgesics after the operation, and will accelerate the child's
recovery and early discharge. This will also reduce parents' anxiety. Therefore, the
pediatric nurse should make the child be acquainted with the operation process by providing
information to the child and the parent within the preoperative preparation programs, and
teach them coping strategies by supporting them with emotional expressions.
The hypotheses of the present study are as follows:
H1: The operating theatre tour shown to children with a 3D virtual headset before the
operation reduces their fear and anxiety.
H2: A documentary shown to children with a 3D virtual headset before the operation reduces
their fear and anxiety.
