FearNCT06027359
The Effect of therapeutıc Game on Preschool chıldren
A study testing Therapeutic play hospital fear and nursing interventions in people with Fear and Nurse, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
In processes such as illness, hospital, medical procedures, and nursing interventions, the fears experienced by children should be reduced before the procedure. It may be more effective to give interventions to reduce children's fears in a school setting rather than in a complex environment such as a hospital. Read more about this study
- Who is it for?
- Ages 60 to 71 monthsHealthy volunteers can take part
- What is being tested?
- Therapeutic play hospital fear and nursing interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child's:
- Between 60 months and 71 months (children over 71 months are educated in the first grade of primary education).
- Having pre-school education
- Absence of any mental and/or physical health problems that would prevent communication belonging to the parent. Belonging to the parent;
- Literacy of the parents
Who cannot join
- The child has any phobia or is receiving treatment for this issue.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of therapeutıc Game on nursıng ınıtıatıves and Fears of medıcal materıals ın Preschool chıldren
In processes such as illness, hospital, medical procedures, and nursing interventions, the fears experienced by children should be reduced before the procedure. It may be more effective to give interventions to reduce children's fears in a school setting rather than in a complex environment such as a hospital. In this context, there is a need for experimental studies that reveal the effect of therapeutic play on nursing interventions and fear of medical materials in preschool children.
Read the detailed description
Entrance: In processes such as illness, hospital, medical procedures, and nursing interventions, the fears experienced by children should be reduced before the procedure. It may be more effective to give interventions to reduce children's fears in a school setting rather than in a complex environment such as a hospital. In this context, there is a need for experimental studies that reveal the effect of therapeutic play on nursing interventions and fear of medical materials in preschool children.
Aim: This study was planned to determine the effect of therapeutic play on nursing interventions and fear of medical materials in preschool children.
Method/ Data Collection Techniques:This research was planned as a quasi-experimental study with pretest-posttest and control group. The universe of the research will consist of 170 children studying in pre-school classes at the Chamber of Commerce Primary School located in the city center of Aydın. The sample size of the study was calculated using G*power analysis and it was found that a total of 70 children (study: 35 children, control: 35 children). However, considering the losses from the research and the possibility of children filling in the questionnaires incomplete or incorrectly, the number of children was increased by 10% and it was planned to complete the study with 80 (study: 40 children, control: 40 children) children. It is planned to collect the data between March 1 and June 1, 2023. The child to be included in the study and their parents will be informed about the study, verbal consent will be obtained from the children and written consent will be obtained from the parents. After obtaining parental consent about the study, the parents of the children in both the study and control groups will have to fill in the "Introductory Information Form" and the children will fill in the "Scale of Fear of Nursing Interventions and Used Materials in Children" before the therapeutic play. The therapeutic game content to be applied to the study group consists of four sessions organized by considering nursing interventions and materials used in the hospital. In each session, various game activities will be held with different materials. Therapeutic play activity will not be planned for the children in the control group. One week after the therapeutic play activities are completed, the children will have to fill out the "Scale of Fear Against Nursing Interventions and Used Materials in Children".
The data obtained in the research will be analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Homogeneity of descriptive features between groups will be tested by chi-square analysis. The Kolmogorov Smirnov Test will be used to determine whether the research data are normally distributed. In the analysis of study data, descriptive statistics, if the data show normal distribution, independent group-t-test and changes within the group repeated measurements Anova test; If it does not have a normal distribution, Mann Whitney-U test and Wilcoxon signed-rank test will be used.
Expected Results: Thanks to the results obtained from this study, it is expected that the familiarity of children with nursing interventions and materials with the therapeutic play method in their own environment such as school will help them experience less fear and adapt easily during a possible hospital experience in the future.
- Being tested
- Therapeutic play hospital fear and nursing interventions
- Keywords
- Fear, hospital, nurse, play therapy, preschool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic play hospital fear and nursing interventionsOther
Children assigned to the study group will be divided into 5 groups, with a maximum of 8 children. The researcher will perform a therapeutic play activity with each group consisting of maximum 8 children one day of the week in the room and time determined by the school. Each activity will last an average of 30 minutes. Therapeutic play activities will be completed in 4 weeks.
- Therapeutic play activities will not be performed with the children in the control group.
- One week after the completion of the therapeutic play intervention, the researcher will re-fill the Child Nursing Interventions and Fear of Materials Scale-uncommon materials sub-dimension face-to-face with the children in the study and control groups.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic game to reduce fear of hospital and ambulance | Experimental | therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks. Receives: Other: Therapeutic play hospital fear and nursing interventions |
| Therapeutic game to reduce fear of injectors and eye drops | Experimental | therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks. Receives: Other: Therapeutic play hospital fear and nursing interventions |
| Therapeutic play to reduce fear of intrauterine and serum | Experimental | therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks. Receives: Other: Therapeutic play hospital fear and nursing interventions |
| Therapeutic play to reduce fear of EKG and EMG | Experimental | therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks. Receives: Other: Therapeutic play hospital fear and nursing interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nursing interventions and fear of materials used in children scale
I am not afraid (1) I am extremely afraid (5). As the score increases, fear increases.
Measured: baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Mar 2023
- Primary completion1 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FearStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz KARACA DEVELİ, Aydin Adnan Menderes University
- Investigators
- Filiz KARACA DEVELİ, Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027359
- Sponsor's protocol ID
- AdnanMU-ÇSHH-FKD-01
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of therapeutıc Game on nursıng ınıtıatıves and Fears of medıcal materıals ın Preschool chıldren
- ClinicalTrials.gov ID
- NCT06027359
- Acronym / sponsor ID
- AdnanMU-ÇSHH-FKD-01
- Keywords
- Fear, hospital, nurse, play therapy, preschool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 7 Sep 2023 (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.
In processes such as illness, hospital, medical procedures, and nursing interventions, the fears experienced by children should be reduced before the procedure. It may be more effective to give interventions to reduce children's fears in a school setting rather than in a complex environment such as a hospital. In this context, there is a need for experimental studies that reveal the effect of therapeutic play on nursing interventions and fear of medical materials in preschool children.
Detailed description
Entrance: In processes such as illness, hospital, medical procedures, and nursing interventions, the fears experienced by children should be reduced before the procedure. It may be more effective to give interventions to reduce children's fears in a school setting rather than in a complex environment such as a hospital. In this context, there is a need for experimental studies that reveal the effect of therapeutic play on nursing interventions and fear of medical materials in preschool children.
Aim: This study was planned to determine the effect of therapeutic play on nursing interventions and fear of medical materials in preschool children.
Method/ Data Collection Techniques:This research was planned as a quasi-experimental study with pretest-posttest and control group. The universe of the research will consist of 170 children studying in pre-school classes at the Chamber of Commerce Primary School located in the city center of Aydın. The sample size of the study was calculated using G*power analysis and it was found that a total of 70 children (study: 35 children, control: 35 children). However, considering the losses from the research and the possibility of children filling in the questionnaires incomplete or incorrectly, the number of children was increased by 10% and it was planned to complete the study with 80 (study: 40 children, control: 40 children) children. It is planned to collect the data between March 1 and June 1, 2023. The child to be included in the study and their parents will be informed about the study, verbal consent will be obtained from the children and written consent will be obtained from the parents. After obtaining parental consent about the study, the parents of the children in both the study and control groups will have to fill in the "Introductory Information Form" and the children will fill in the "Scale of Fear of Nursing Interventions and Used Materials in Children" before the therapeutic play. The therapeutic game content to be applied to the study group consists of four sessions organized by considering nursing interventions and materials used in the hospital. In each session, various game activities will be held with different materials. Therapeutic play activity will not be planned for the children in the control group. One week after the therapeutic play activities are completed, the children will have to fill out the "Scale of Fear Against Nursing Interventions and Used Materials in Children".
The data obtained in the research will be analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Homogeneity of descriptive features between groups will be tested by chi-square analysis. The Kolmogorov Smirnov Test will be used to determine whether the research data are normally distributed. In the analysis of study data, descriptive statistics, if the data show normal distribution, independent group-t-test and changes within the group repeated measurements Anova test; If it does not have a normal distribution, Mann Whitney-U test and Wilcoxon signed-rank test will be used.
Expected Results: Thanks to the results obtained from this study, it is expected that the familiarity of children with nursing interventions and materials with the therapeutic play method in their own environment such as school will help them experience less fear and adapt easily during a possible hospital experience in the future.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Therapeutic game to reduce fear of hospital and ambulance | Experimental | Other: Therapeutic play hospital fear and nursing interventionstherapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks. |
| Therapeutic game to reduce fear of injectors and eye drops | Experimental | Other: Therapeutic play hospital fear and nursing interventionstherapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks. |
| Therapeutic play to reduce fear of intrauterine and serum | Experimental | Other: Therapeutic play hospital fear and nursing interventionstherapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks. |
| Therapeutic play to reduce fear of EKG and EMG | Experimental | Other: Therapeutic play hospital fear and nursing interventionstherapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks. |
Who may qualify
- Ages
- 60 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Between 60 months and 71 months (children over 71 months are educated in the first grade of primary education).
- Having pre-school education
- Absence of any mental and/or physical health problems that would prevent communication belonging to the parent. Belonging to the parent;
- Literacy of the parents
Key exclusion criteria (1 listed)
- The child has any phobia or is receiving treatment for this issue.
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 play hospital fear and nursing interventionsChildren assigned to the study group will be divided into 5 groups, with a maximum of 8 children. The researcher will perform a therapeutic play activity with each group consisting of maximum 8 children one day of the week in the room and time determined by the school. Each activity will last an average of 30 minutes. Therapeutic play activities will be completed in 4 weeks. * Therapeutic play activities will not be performed with the children in the control group. * One week after the completion of the therapeutic play intervention, the researcher will re-fill the Child Nursing Interventions and Fear of Materials Scale-uncommon materials sub-dimension face-to-face with the children in the study and control groups. | Other | Therapeutic game to reduce fear of hospital and ambulance, Therapeutic game to reduce fear of injectors and eye drops, Therapeutic play to reduce fear of EKG and EMG, Therapeutic play to reduce fear of intrauterine and serum |
Primary outcome
Nursing interventions and fear of materials used in children scale
Time frame: baseline and week 4
I am not afraid (1) I am extremely afraid (5). As the score increases, fear increases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Filiz KARACA DEVELİ principal investigator
Aydin Adnan Menderes University
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 hospital fear and nursing interventions in people with Fear and Nurse, run by Aydin Adnan Menderes 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 14 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nursing interventions and fear of materials used in children scale (time frame: baseline and week 4). 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 14 Sep 2023.