The Effect of Therapeutic Play Applied Before Intramuscular Injection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorAtaturk University
About this trial
This research aims to evaluate the effectiveness of a therapeutic toy doll developed to reduce the levels of fear, anxiety and pain experienced by children aged 4-6 during intramuscular injection procedures.
Children, especially at an early age, show great sensitivity towards medical procedures, and these processes can often cause pain, anxiety and fear. This research aims to evaluate the effectiveness of a therapeutic toy doll developed to reduce the levels of fear, anxiety and pain experienced by children aged 4-6 during intramuscular injection procedures. Children, especially at an early age, show great sensitivity to medical procedures, and these processes can often cause pain, anxiety, and fear. This research aims to discover methods of managing and improving children's responses to medical procedures through therapeutic games.
This study, to be conducted at the Emergency Department of Atatürk University Research Hospital in Erzurum, will be carried out using a randomised controlled design. Participants will be randomly assigned to intervention and control groups. Children in the intervention group will prepare using the therapeutic toy doll, while children in the control group will receive an intramuscular injection at the clinic using routine application methods.
Data collection tools will include the Socio-demographic Information Form, the Children's Fear Scale (CFS), the Children's Anxiety Scale-State (CAS-D), and the Wong-Baker Facial Expression Rating Scale.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children aged 4-6 years,
Those who will receive intramuscular injections,
Those who have been prescribed Desefin flk 1x1 IM,
Children whose parents have given consent will be included in the study.
Disqualifiers
Those experiencing pain,
Those with hearing problems and communication barriers,
Those with chronic illnesses,
Those with mental and physical disabilities,
Trial design
Design model
Parallel
Treatments tested in this trial
therapeutic play
BehavioralChildren in the intervention group will be introduced to therapeutic toy dolls and will be educated on what to do with them. Prior to the training, children will be informed about the importance of intramuscular injections and how they are administered. The reasons for the injection and how it is administered will be explained in detail. Participants will be shown the steps involved in intramuscular injection. Using a toy doll, the steps of intramuscular injection will be demonstrated step by step, and the children will practise applying these steps. During the training, children will be told in detail how to administer injections carefully, where the injection should be given, and how to perform the injection correctly. At the end of the training, children will successfully perform the intramuscular injection procedure. The injection will then be administered to the children by the same nurse who received training from the research team.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: therapeutic playExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Child Fear Scale
The scale was developed by McMurty et al. to measure fear in children undergoing painful medical procedures. Its validity and reliability in Turkish were established by Gerçeker et al. The scale features five distinct facial expressions, ranging from no fear/anxiety at one end to very intense fear/anxiety at the other, and is scored on a scale of 0 to 4. 0 indicates no fear/anxiety, while 4 indicates extreme fear and anxiety
Time frame
1 year2
Child Anxiety Scale-State
The scale developed by Ersig et al. has been validated and tested for reliability in Turkish by Özalp Gerçeker et al. The CAS-D resembles a thermometer with a bulb at the bottom and horizontal lines extending upwards at intervals. In this scale, which is aimed at children aged four to ten, children are instructed to "think of all your anxious or nervous feelings as being in the bulb or lower part of the thermometer. If you feel a little anxious or nervous, your feelings may rise a little higher on the thermometer. If you are very, very anxious or nervous, your feelings may go all the way to the top. Place a line on the thermometer to show how anxious or nervous you are." To measure state anxiety (CAS-D), the child is asked to mark how they feel 'right now'. A transparent ruler marked in ½-point increments is placed over the child's rating, and the ½-point increment is then rounded to the nearest number. The score can range from 0 to 10.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov