NCT06027359

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
Last Updated

September 14, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

August 24, 2023

Last Update Submit

September 13, 2023

Conditions

Keywords

Fear, hospital, nurse, play therapy, preschool

Outcome Measures

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.

    baseline and week 4

Study Arms (4)

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.

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.

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.

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.

Other: Therapeutic play hospital fear and nursing interventions

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.

Therapeutic game to reduce fear of hospital and ambulanceTherapeutic game to reduce fear of injectors and eye dropsTherapeutic play to reduce fear of EKG and EMGTherapeutic play to reduce fear of intrauterine and serum

Eligibility Criteria

Age60 Months - 71 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Filiz KARACA DEVELİ

Efeler, Aydın, 09100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Filiz KARACA DEVELİ

    Aydin Adnan Menderes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 24, 2023

First Posted

September 7, 2023

Study Start

March 1, 2023

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

September 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations