The Effect of Therapeutic Play Applied Before Intramuscular Injection

NCT07378995 | Recruiting

• 1 other identifier: 30.2.ATA.0.01.0
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Child, Only; Fear; Pain

Outcome Measures

Primary Outcomes (2)

• 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

  1 year

• 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.

  1 year

Study Arms (2)

therapeutic play

EXPERIMENTAL

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.

Behavioral: therapeutic play

control

NO INTERVENTION

Children in the control group will receive the IM injection at the clinic using routine practice methods.The injection will be administered by the same nurse trained by the research team.

Interventions

therapeutic play BEHAVIORAL

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.

therapeutic play

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Nursing of Faculty

Erzurum, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Play Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 30, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)