Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06199206 |
| Other study ID # |
E-46059653-050.99-232013695 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2024 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Maltepe University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study will be conducted with the randomized controlled experimental method. The children
who attended the pediatric department will divide into two groups via randomization in the
computer environment. After random selection, children in the intervention group will play a
therapeutic game before the lumbar puncture procedure. Children in the control group will not
undergo any procedure before the lumbar puncture procedure. Parents will be present with
their children in both groups during the procedure. While the child's anxiety and fear level
is measured, the parent's anxiety level will also be measured.
Description:
For the child, illness and hospitalization are frightening, disturbing and unpleasant
situations. Children are more fragile and sensitive than adults because they are inadequate
to meet their health care needs and have not completed sufficient physical, cognitive and
social development. Whether the disease is acute or chronic, the pain or limitation of
movement it causes, the need for isolation, the child's previous hospitalization and stress
experiences, the state of preparation for hospitalization, the anxiety level of family
members and intra-family relationships affect the child's response to the disease and
hospitalization. Medical interventions performed in a hospital environment are among the
stimuli that create psychological and physiological stress in the child. It has been
determined that children are not given effective education before medical procedures, and
children who do not receive adequate preparation experience increased fear and anxiety, and
experience problems such as feelings of insecurity and rejection of interventions. In
addition, this experience causes the child to develop negative reactions to later hospital
experiences. One of the medical interventions performed on children in the hospital
environment is lumbar puncture (LP). Lumbar puncture is a method that has been used by
different disciplines for diagnosis and treatment purposes for years. When the LP procedure
is performed on children compared to adults, it may cause more anxiety and fear in both the
child and their parents. Increased levels of anxiety and fear may cause children and parents
to reject the procedure. Nurses have important roles in reducing the stress, anxiety and fear
of children and their parents during these medical procedures. In line with the
family-centered care philosophy, nurses should inform the child and their parents about the
procedure and prepare the child for the procedure with methods such as therapeutic games.
With the therapeutic play method, the child's negative emotions such as fear and anxiety
regarding the procedure can be managed. This research will be conducted to determine the
effect of therapeutic play applied to children between the ages of 6 and 12, who are admitted
to the pediatric ward, before the LP procedure, on the children's anxiety and fear levels and
their parents' anxiety levels.
The sample size of the study has been determined by the power analysis (G*Power 3.1), in line
with the results obtained from the studies which have been conducted using a similar research
method. The sample size was found to be a total of 28 children including minimum of 14
children for each group. It was estimated that case losses may occur and therefore, it was
decided to conduct the study with a total of 34 children including 17 children in two groups.
Children who meet the average selection criteria prior to data collection will be identified.
Verbal and written permission will be obtained from the children of the selected students to
participate, and verbal consent will be obtained from the children through the 'Informed
Voluntary Consent Form'.
LP storage in children in both control and intervention periods; Routine practices in the
clinic will be carried out before, during and after the procedure. Written consent will be
given for the procedure. For those who do not agree to have the LP procedure, intermittent
oral feeding (solid oral intake for two hours, liquid oral intake for six hours) will be
discontinued and preparations for the procedure will be made.
No application will be made to reveal the fear and anxiety levels of the control groups. Only
children and their parents will be informed about the transaction. Five minutes before the
procedure within the scope of the research, the "State-Trait Anxiety Inventory" and
"Children's Fear Scale" for children and the "Beck Anxiety Scale" for parents will be
evaluated. Intervention Group: Children in the intervention group and their parents will play
therapeutic games with specially prepared eLPi dolls and other play materials before the
procedure. The parent will be with the child during this game, which will be played in the
child's own room and bed. Before the procedure, the "State-Trait Anxiety Inventory" and the
"Children's Fear Scale" will be used for children and the "Beck Anxiety Scale" will be used
for parents. Therapeutic play steps; First, the child's temperature will be measured with a
thermometer on one of the eLPi dolls of his/her own choosing. An oxygen mask will be attached
to the doll with a high fever, it will be positioned, and some liquid will be drawn into the
syringe from balls containing liquid placed on the back in accordance with the anatomy. After
covering the back area with gauze, that liquid will be examined with the child under the toy
microscope. After the therapeutic game, the child will enter the sterilely prepared
intervention room with the child. Before the LP procedure, the activity of the child's
vascular access will be checked, an oxygen mask will be applied and monitored. During the LP
procedure, the child will be positioned and sedation planned according to the child's weight
will be administered intravenously. After the CSF samples are taken, the blood sugar level
will be checked. The area where the LP procedure is performed will be covered with gauze for
twenty-four hours. After the LP procedure, the patient will be kept in the intervention room
for thirty to forty-five minutes to ensure that the sedation wears off and the child's
general condition is observed. One hour after the LP procedure, the anxiety of children in
both the intervention and control groups will be determined with the "State-Trait Anxiety
Inventory" scale, and the children's fear will be determined with the "Children's Fear
Scale". Additionally, the "Beck Anxiety Scale" will be applied to determine the anxiety level
of the parents.
