Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:19 AM
Study NCT ID:
NCT07378995
Status:
RECRUITING
Last Update Posted:
2026-01-30
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Therapeutic Play Applied Before Intramuscular Injection
Sponsor:
Ataturk University
Organization:
Study Overview
Official Title:
The Effect of Therapeutic Play Applied Before Intramuscular Injection on Fear, Anxiety and Pain in Pre-school Children
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
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.The original value of the research lies in the development of a therapeutic toy doll for intramuscular injection and in evaluating the effect of this therapeutic toy doll on children undergoing the injection procedure through therapeutic play. The therapeutic toy doll aims to familiarise children with the injection process and make them find this process less frightening, thereby experiencing less stress during the actual injection.
This approach aims to reduce children's fear, anxiety, and pain levels towards medical procedures and help them develop a positive outlook.
The expected results of the research indicate that children who receive injections with the therapeutic toy doll may experience a significant reduction in their levels of fear, anxiety, and pain. The therapeutic toy doll may help children cope with challenging medical situations and enable them to interpret their experiences with healthcare services in a more positive manner. The research findings will contribute to the development of new strategies for medical procedures in paediatric care that result in less fear, pain, and anxiety. Healthcare professionals and families will gain practical and effective tools to facilitate children's adaptation to medical procedures.
This research will contribute to raising standards in children's healthcare services and offer innovative approaches that enable children to have more positive health experiences.
This research aims to present innovative approaches that will enable the raising of standards in children's health services and allow children to have more positive health experiences.
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.The original value of the research lies in the development of a therapeutic toy doll for intramuscular injection and in evaluating the effect of this therapeutic toy doll on children undergoing the injection procedure through therapeutic play. The therapeutic toy doll aims to familiarise children with the injection process and make them find this process less frightening, thereby experiencing less stress during the actual injection.
This approach aims to reduce children's fear, anxiety, and pain levels towards medical procedures and help them develop a positive outlook.
The expected results of the research indicate that children who receive injections with the therapeutic toy doll may experience a significant reduction in their levels of fear, anxiety, and pain. The therapeutic toy doll may help children cope with challenging medical situations and enable them to interpret their experiences with healthcare services in a more positive manner. The research findings will contribute to the development of new strategies for medical procedures in paediatric care that result in less fear, pain, and anxiety. Healthcare professionals and families will gain practical and effective tools to facilitate children's adaptation to medical procedures.
This research will contribute to raising standards in children's healthcare services and offer innovative approaches that enable children to have more positive health experiences.
This research aims to present innovative approaches that will enable the raising of standards in children's health services and allow children to have more positive health experiences.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: