RecruitingNot ApplicableNCT07378995

The Effect of Therapeutic Play Applied Before Intramuscular Injection

The Effect of Therapeutic Play Applied Before Intramuscular Injection on Fear, Anxiety and Pain in Pre-school Children


Sponsor

Ataturk University

Enrollment

80 participants

Start Date

Dec 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 4 YearsMax Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether a therapeutic play intervention (a guided, child-friendly play activity) performed before an intramuscular injection reduces pain and anxiety in young children aged 4–6 years. **You may be eligible if...** - The child is between 4 and 6 years old - The child is scheduled to receive an intramuscular injection (specifically Desefin 1x1 IM) - A parent or guardian has given consent for the child to participate **You may NOT be eligible if...** - The child is currently experiencing pain - The child has hearing problems or communication difficulties - The child has a chronic illness - The child has a mental or physical disability - The child has taken a pain reliever in the last 6 hours - The child has been hospitalized before Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALtherapeutic play

Children 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.


Locations(1)

Ataturk University Nursing of Faculty

Erzurum, Turkey (Türkiye)

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NCT07378995


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