CClinicalTrials.gg
CompletedNCT06027359Updated Sep 14, 2023

The Effect of therapeutıc Game on Preschool chıldren

An interventional study of Therapeutic play hospital fear and nursing interventions in Fear, Nurse and Hospital, sponsored by Aydin Adnan Menderes University. Completed at 1 site in Turkey. Open to participants aged 60 Months to 71 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-14.

Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Mar 2023, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
60 Months to 71 Months
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Fear
  • Nurse
  • Hospital

Keywords

  • Fear, hospital, nurse, play therapy, preschool
03

In context

Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 236 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Months to 71 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

The child has any phobia or is receiving treatment for this issue.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Therapeutic game to reduce fear of hospital and ambulance

    therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.

    Other: Therapeutic play hospital fear and nursing interventions

  • Experimental
    Therapeutic game to reduce fear of injectors and eye drops

    therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.

    Other: Therapeutic play hospital fear and nursing interventions

  • Experimental
    Therapeutic play to reduce fear of intrauterine and serum

    therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.

    Other: Therapeutic play hospital fear and nursing interventions

  • Experimental
    Therapeutic play to reduce fear of EKG and EMG

    therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.

    Other: Therapeutic play hospital fear and nursing interventions

Interventions

  • OtherTherapeutic play hospital fear and nursing interventions

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline and week 4

07

Study locations

1 site
  • Filiz KARACA DEVELİ
    Efeler, Aydın 09100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06027359
Lead sponsor
Aydin Adnan Menderes University
Responsible party
Filiz KARACA DEVELİ (Principal Investigator, Aydin Adnan Menderes University) — Principal investigator
First posted
Sep 7, 2023
Start date
Mar 1, 2023
Primary completion
May 1, 2023
Completion
Jun 1, 2023
Last update
Sep 14, 2023

Study contacts

Filiz KARACA DEVELİ
principal investigator · Aydin Adnan Menderes University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion