Actively Recruiting

Phase Not Applicable
Age: 4Years - 6Years
All Genders
Healthy Volunteers
NCT07378995

The Effect of Therapeutic Play Applied Before Intramuscular Injection

Led by Ataturk University · Updated on 2026-01-30

80

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Effect of Therapeutic Play Applied Before Intramuscular Injection

Who Can Participate

Age: 4Years - 6Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 4 to 6 years
  • Children who will receive intramuscular injections
  • Children prescribed Desefin flk 1x1 IM
  • Children whose parents have given consent to participate
Not Eligible

You will not qualify if you...

  • Children currently experiencing pain
  • Children with hearing problems or communication barriers
  • Children with chronic illnesses
  • Children with mental or physical disabilities
  • Children who have taken analgesics within the last 6 hours
  • Children who have been previously hospitalised

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Ataturk University Nursing of Faculty

Erzurum, Turkey (Türkiye)

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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