The Effect of Therapeutic Play Applied Before Intramuscular Injection

Recruiting now · Not applicable

Conditions studied: Child, Only, Fear, Pain

In brief

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.

Key facts

Study ID

NCT07378995

Run by

Ataturk University

People needed

80

Starts

2025-12-30

Expected to finish

2027-12-30

Last updated by the study team

2026-01-30

Who can join

Age: 4 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Those experiencing pain,
• Those with hearing problems and communication barriers,
• Those with chronic illnesses,
• Those with mental and physical disabilities,
• Those who have taken analgesics within the last 6 hours,
• Children who have previously been hospitalised will not be included in the study.

Where it is running

• Ataturk University Nursing of Faculty — Erzurum, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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