Child, OnlyNCT07378995
The Effect of Therapeutic Play Applied Before Intramuscular Injection
A study testing therapeutic play in people with Child, Only and Fear, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only, Fear, Pain
- What is being tested?
- therapeutic play
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University Nursing of Faculty
Erzurum
ARZU SARIALIOGLU, 04422315795, arzu.celebi@atauni.edu.tr
About this study
Official title: The Effect of Therapeutic Play Applied Before Intramuscular Injection on Fear, Anxiety and Pain in Pre-school Children
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.
Read more
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.
Read the 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.
- Conditions
- Child, Only, Fear, Pain
- Being tested
- therapeutic play
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic playBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start30 Dec 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARZU SARIALİOĞLU, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378995
- Sponsor's protocol ID
- 30.2.ATA.0.01.0
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Play Applied Before Intramuscular Injection on Fear, Anxiety and Pain in Pre-school Children
- ClinicalTrials.gov ID
- NCT07378995
- Acronym / sponsor ID
- 30.2.ATA.0.01.0
- Conditions
- Child, Only, Fear, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| therapeutic play | Experimental | Behavioral: therapeutic playChildren 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. |
| 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. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic playChildren 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. | Behavioural | therapeutic play |
Primary outcome
Child Fear Scale
Time frame: 1 year
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
Child Anxiety Scale-State
Time frame: 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic play in people with Child, Only and Fear, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Fear Scale (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.