NCT06763263

Brief Summary

Healthcare professionals and administrators who serve children are aware of the role of play in children's lives and with this awareness, they design playrooms and areas for children in hospitals. Nurses who consider play as an important atraumatic care approach that supports the child's development, reduces stress and anxiety, and thus contributes to the improvement of hospital compliance have conducted some studies on this subject. Sarman (2022) found in his study that animal-assisted treatment with aquarium fish in the hospital for children aged 8-10 was effective in reducing children's fear and anxiety, strengthening positive emotions, ensuring that the hospital environment was accepted as safe, reducing the feeling of loneliness and facilitating adaptation to the hospital. In another study, play and art therapy was applied to hospitalized children between the ages of 2 and 4, and it was determined that play therapy was more effective in reducing children's anxiety than art therapy and the control group. In their study evaluating the effect of the "hospital friend, Yarencik" initiative on the hospital adaptation of children aged 1-3, Özcan and Güdücü Tüfekci (2022) found that the hospital adaptation of the intervention group after the application was significantly higher than the control group. Although the above studies show that studies using developmentally appropriate and attractive methods to increase the compliance of young children to hospitalization are effective, the number of methods and studies tested is limited. Finding the best method to increase the compliance of young children to hospital and providing evidence that will form the basis for the development and updating of guides or guides is an important requirement.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

January 17, 2025

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

January 2, 2025

Last Update Submit

January 16, 2025

Conditions

Keywords

Hospitalization in childrenChildNursing

Outcome Measures

Primary Outcomes (2)

  • Sociodemographic Questionnaire

    This form was prepared by researchers in line with the literature in order to determine the sociodemographic characteristics of the children and to learn their thoughts about the hospital It consists of 14 questions that include the sociodemographic characteristics of the child and the family and information about the hospital.

    During the children's first hospitalization, the researcher will fill out Sociodemographic Questionnaire ( Approximately 10 minute).

  • Children's Hospital Adaptation Evaluation Scale (CHILD-HÜDO)

    The scale, developed in Turkey to evaluate the hospitalization of mothers' 1-3 year old children, is a 5-point Likert-type scale (1-Continuous, 2- Frequently, 3- Occasionally, 4- Very little, 5- Never). It was prepared for children aged 1-3 who are hospitalized. The Scale for Evaluating Children's Hospital Adaptation consists of 22 items and a single dimension. The scale was developed by Özcan and Güdücü Tüfekci by 2022. The lowest score that can be obtained from the scale is 22, and the highest score is 110. As the score obtained from the scale increases, the children's adaptation to the hospital increases. There is no reverse-scored item in the scale. Cronbach's alpha was determined as 0.818 for the entire scale.

    It will be filled out by the researcher and parent before and after the procedure (Approximately 10 minute).

Study Arms (2)

Experimental: Superhero Clothing and Figure Group

EXPERIMENTAL

Superhero Clothing and Figure Group

Behavioral: Experimental

Active:Control

ACTIVE COMPARATOR

Control

Behavioral: Control

Interventions

ExperimentalBEHAVIORAL

Children and their parents in this group will be informed about the research and their verbal and written consent will be obtained. A questionnaire will be filled out before the application. Then, the child will be allowed to choose one of the superhero clothes he/she wants in his/her room and will be allowed to wear the clothes. The superhero figure will be shown to him/her and he/she will be allowed to play with the clothes and the figure for 2 hours.

Experimental: Superhero Clothing and Figure Group
ControlBEHAVIORAL

The children in this group and their parents will be informed about the research and their verbal and written consent will be obtained. A questionnaire will be filled out before the application. The children will be evaluated in terms of their reactions after their hospitalization, they will not be dressed in any clothing and no superhero figures will be used. Then the questionnaire will be filled out again and scoring will be done. In order to prevent ethical bias before discharge, the child will be dressed in a superhero costume and will be allowed to spend time with the clothing and figure.

Active:Control

Eligibility Criteria

Age24 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The child's age range is between 24-36 months
  • On the first day of the child's hospitalization
  • The child is hospitalized with an acute problem
  • It is the child's first hospitalization
  • The child will probably stay in the hospital for at least three days.
  • Parent's ability to read and write Turkish
  • Parent must be over 18 years of age
  • Parent's consent to participate in the research

You may not qualify if:

  • The child has a mental health problem
  • The child receives daily outpatient treatment at the hospital
  • Children hospitalized with their siblings
  • The parent has a known psychiatric problem
  • Parent has communication problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was planned as a pre-test, post-test parallel group (invertion-control), randomized controlled experimental research type.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master Student/Nurse

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 8, 2025

Study Start

December 30, 2024

Primary Completion

March 30, 2025

Study Completion

June 30, 2025

Last Updated

January 17, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations