Clinical trial NCT05747833: The Effect of Toy IV Catheter on Children's Pain, Fear and Emotional Indicators
Official title: Randomized Controlled Trial: The Effect of Preparation for Procedure With Toy IV Catheter Before Peripheral Cannula Administration on Children's Pain, Fear, and Emotional Indicators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Catheterization
Keywords: Toy
Therapeutic play
Preparation
Pain
Fear
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Your child;
* Age between 6-10,
* To receive IV treatment upon the request of a physician,
* Being conscious and able to communicate verbally,
* Understanding and speaking Turkish,
* Having a mother and / or father with him,
* After the information, the child and his parents agree to participate in the study in writing and verbally,
* Pediatric Emergency Clinic has been accepted to the Green Area,
* Not using analgesic and / or sedative drugs in the last 8 hours.

Exclusion Criteria:

* Your child;
* Being younger than 6 and over 10 years old,
* Having pain,
* Having a high fever (body temperature of 38 ° C and above) Applying to the hospital with a complaint that requires urgent intervention such as convulsion or trauma,
* Having applied to the hospital by ambulance,
* Admitted to the Yellow or Red Area of the Pediatric Emergency Clinic after triage,
* Having had an IV catheter before,
* Having mental disability,
* Having a chronic and / or fatal disease, Having a diagnosis made by psychiatry,
* Communication problems with his family and / or himself (not speaking Turkish, agitation, etc.)

Primary outcomes:
measure: Personal data collection form
timeFrame: 1.5 month
measure: Wong-Baker faces pain scale
timeFrame: 1.5 month
measure: Child Fear Scale
timeFrame: 1.5 month
measure: Child Emotional Manifestation Scale
timeFrame: 1.5 month
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Hazal
state: Odunpazarı
Study officials:
affiliation: Eskişehir Osmangazi University
name: Hazal USLU
role: STUDY_DIRECTOR
References: