Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05747833 |
| Other study ID # |
10346826 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 14, 2020 |
| Est. completion date |
December 30, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Eskisehir Osmangazi University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Aim: Research was conducted to determine the effect of preparation for the procedure with a
toy IV catheter before IV catheterization in children aged 6-10 years, on children's pain,
fear and emotional indicators.
Methods: It is a randomized controlled intervention study. The study was completed with 80
children. There are two groups in the study. Before the IV catheterization, the children in
the intervention group were treated with the toy IV catheter developed by the researchers on
the knitted doll, and then the procedure was provided to them. Conversely, no intervention
was applied to the control group other than the normal procedure of the hospital. Stratified
block randomization method was used to assign children to groups. In the study; "Personal
Data Collection Form", "Wong-Baker Faces Pain Scale (WBFPS)", "Child Fear Scale (CFS)" and
"Child Emotional Manifestation Scale (CEMS)" were used to collect data.
Description:
Children may be sick during their normal development and may have to come to the hospital.
For children, the hospital environment, especially emergency rooms, conveys uncertainty. The
reason for this uncertainty; the presence of health team members that children do not know,
equipment they have not seen before, and interventions. The child's sense of uncertainty and
the thought that his own control is in danger may cause him to become stressed and afraid of
the hospital. As a matter of fact, studies on children's hospital experience indicate that
they experience negative emotions such as stress, anger, restlessness, and tension. It is
known that the most common negative emotion and experience children experience in the
hospital environment is anxiety due to pain and fear.
Children can experience pain in all healthcare settings. Almost all diagnostic and
therapeutic applications cause pain. It is also known that children experience more fear in
the hospital environment than adults. Among the biggest fears children experience in the
hospital environment are; Losing body functions, having surgery can be counted as painful
invasive procedures performed for diagnosis and treatment. Especially made using a needle
such as an injector; Procedures such as vaccination, bloodletting, and IV catheterization may
cause pain and fear in children.
More than 80% of children admitted to hospitals are administered IV catheters. Almost all
children are adversely affected by this process. In reducing these negative emotions
experienced, it is very important to prepare children for the procedure. Control of pain and
fear; requires cooperation between physicians, nurses and other health professionals.
Especially nurses have important duties in this regard, as they have the opportunity to
observe the patient closely and for a longer period of time. The American Association of Pain
Management Nursing (ASPMN) also reports that nurses are responsible for controlling pain
using pharmacological and non-pharmacological methods before, during and after painful
intervention. For this purpose, therapeutic play can be used.
Therapeutic play is a type of play used to reduce the child's fear and stress towards the
hospital, to alleviate the feeling of uncertainty, to evaluate misunderstandings about the
hospital environment and the interventions applied in the hospital, to teach clinical
procedures and to reduce pain in painful procedures. Ensuring that the child touches the
tools and equipment to be used in the treatment during the game played in the hospital allows
him to recognize them and perceive them as less threatening. At the same time, it improves
the feeling of trust towards the health professional. Particularly, when preparation for
play-based treatment is combined with treatment, the child can better tolerate painful
procedures by developing positive coping methods. As a matter of fact, in the experimental
study of Uluışık (2019) with 60 children aged 5-6 years, it was seen that the information
provided with the play dough consisting of a dentist set reduced dental fear. In a randomized
controlled study conducted by Miller et al. (2016) with 98 children aged 3-12, using an
electronic device called Ditto (Diversionary Therapy Technologies, Brisbane, Australia) that
provides procedural preparation and distraction during the vascular access procedure,
significantly reduced stress. In another study conducted by Tunç Tuna and Açikgoz (2015) on
60 children aged 9-12, it was found that pre-procedural information on preparation for the
peripheral venous cannula application in children and performing the procedure by showing it
on the toy reduced the child's pain and anxiety. In the study conducted by Tunç Tuna and
Açikgöz, real IV catheters were used in preparation for the procedure before the peripheral
cannula application of the children. However, giving such tools and equipment to the hands of
especially small children and having them applied can be dangerous and harmful for them.
Instead, alternative methods should be developed.For example, the process can be explained
through pictures and/or the toys/models of the tools to be used in the process can be given
to children and practice can be made. In the literature review, no study could be found on
the preparation of the child for the procedure with realistic toys before the IV
catheterization procedure.
