Therapeutic toy doll used before intramuscular injections to calm young children.
The Effect of Therapeutic Play Applied Before Intramuscular Injection on Fear, Anxiety and Pain in Pre-school Children
This project will test whether playing with a therapeutic toy doll just before an intramuscular injection helps children aged 4–6 feel less fear, anxiety, and pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 4 Years to 6 Years |
| Sex | All |
| Sponsor | Ataturk University Academic / other |
| Locations | 1 site (Erzurum) |
| Trial ID | NCT07378995 on ClinicalTrials.gov |
What this trial studies
This randomized controlled study at the Emergency Department of Atatürk University Research Hospital in Erzurum will assign children to an intervention group that uses a therapeutic toy doll before an intramuscular injection or to a control group receiving routine care. Eligible children are ages 4–6 who have been prescribed Desefin flk 1x1 IM and whose parents consent, with exclusions for recent analgesic use, chronic illness, sensory or communication barriers, prior hospitalization, and current pain. Outcomes measured before and after the procedure include the Children's Fear Scale (CFS), Children's Anxiety Scale-State (CAS-D), and the Wong-Baker Faces Pain Rating Scale, plus demographic information. The therapeutic doll is intended to familiarize children with the injection process through play so the real injection causes less distress.
Who should consider this trial
Good fit: Children aged 4–6 who will receive an intramuscular Desefin flk 1x1 IM injection and whose parents provide consent are the intended participants.
Not a fit: Children with hearing or communication barriers, chronic illnesses, mental or physical disabilities, recent analgesic use within 6 hours, current pain, or prior hospitalisation are excluded and may not benefit from this approach.
Why it matters
Potential benefit: If successful, the toy could help children experience less fear, anxiety, and pain during routine intramuscular injections.
How similar studies have performed: Prior research on distraction and therapeutic play in pediatric procedures has often shown reductions in fear and pain, though this specific therapeutic doll is a novel tool.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Erzurum
- Ataturk University Nursing of Faculty — Erzurum, Turkey (Türkiye) (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.