Child in Hospital and Playing

Sponsor
Adiyaman University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06052761
Collaborator
(none)
80
2
5

Study Details

Study Description

Brief Summary

Being hospitalized is a stressful process for the child and her family. Management of stress is important to accelerate the child's recovery process and ensure early discharge. It is thought that playing with toys made using medical materials will reduce children's stress. This project aims to determine the effect of playing with toys made with medical materials on the stress of a hospitalized child. It is planned to collect the data of the project from pediatric patients aged 4-6 years hospitalized in the pediatric clinic of a training and research hospital in the Southeastern Anatolia Region. It is planned to analyze the data obtained from pediatric patients by using the SPSS program. As a result of the project, it is aimed that the game played with toys made using medical materials will reduce the stress of children.

Condition or Disease Intervention/Treatment Phase
  • Other: Making Toys from Medical Materials
N/A

Detailed Description

Children whose immune systems are not yet fully mature may encounter many acute or chronic diseases throughout their development and therefore may need to be hospitalized (Gültekin and Baran, 2005; Lerwick, 2013). Staying in an unknown environment such as a hospital causes children to experience feelings such as anxiety and fear (Callefi et al, 2016).

Hospitalization, which is a stressful process for both the child and his family, causes financial and social changes for the child and his family. Being unfamiliar with the disease, the hospital environment, the procedures to be performed, and the feeling of not having control over the procedures also create stress on the child and the family. In addition to the stress experienced, the effects of their treatments on the central nervous system and the biological stress they bring negatively affect the development of hospitalized children. Hospitalized children experience different emotions due to the unknown environment, unfamiliar people in this environment, unknown tools and equipment, and frightening sounds and smells. For children, being sick and being hospitalized can easily lead to a crisis (Oktay, 2004; Er, 2006; Çavuşoğlu, 2013; Atay ve ark, 2011).

It is an indisputable fact that regardless of the age of the child, being separated from his family and hospitalized creates great stress for him (Çelebi et al, 2015). Effectively managing the stress of hospitalized children will shorten the hospitalization process by facilitating the child's adaptation to the disease and the hospital. When it comes to children, the first thing that comes to mind is play. For this reason, it is thought that the child will best cope with stress through play. It seems that play is an effective tool in helping hospitalized children cope with stress (Çavuşoğlu, 2013; Atay et al., 2011: Törüner and Büyükgönenç, 2012). When the literature was examined, studies were found examining the effects of games such as tablet games (Yildiz et al, 2022), outdoor games (Larsen et al, 2022), and digital games oyun (Montaner et al, 2019; Matthyssens et al, 2020) on hospitalized children. In a study, the effect of playing with toys made with medical materials on the pain of children with cancer was evaluated (Aslan and Erci, 2022). However, no study has been found examining the effect of playing with toys made using medical materials on the anxiety of hospitalized children. This study was planned as a randomized controlled study to examine the effect of playing with toys made of medical materials on the anxiety of hospitalized children.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Hospitalized Child and Play: Toys Made of Medical Materials
Anticipated Study Start Date :
Oct 15, 2023
Anticipated Primary Completion Date :
Feb 15, 2024
Anticipated Study Completion Date :
Mar 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Making Toys from Medical Materials

The purpose of the study will be explained to the children and their parents before the procedure, and verbal and written consent will be obtained from the parents who agree to participate in the study. Children's anxiety will be evaluated using the "Children's State Anxiety Scale (CSA)" before and after the procedure (half an hour after the first measurement), based on the statements of both the mother and the child.

Other: Making Toys from Medical Materials
Rabbit Making: The two fingers and the palm of the medical glove will be filled with cotton and the bottom part will be tied. The finger part of the glove will form the rabbit's ears, and the palm part will form its face. After the glove is shaped, the rabbit's eyes and mouth will be drawn with a pencil. Cat Making: Three abeslangs will be cut to appropriate sizes to create the cat. The cut pieces will be combined to form the cat's head, feet, and tail. After the assembly process is completed, the cat's eyes, nose and beard will be drawn with a pencil. Plane Making: The 10 cc syringe and needle tip removed from its packaging will be combined. Children will be asked to color the two abeslangs given to them in the color they want. The abeslangs painted by the children will be fixed to the syringe with a plaster, one on the bottom and the other on the top.

No Intervention: Control group

The purpose of the study will be explained to the children and their parents before the procedure, and verbal and written consent will be obtained from the parents who agree to participate in the study. No procedures will be performed other than routine procedures performed in the hospital. Children's anxiety will be evaluated based on the statements of both the mother and the child, using the "Children's State Anxiety Scale (CSA)" after obtaining consent from the parents and half an hour after the first measurement.

Outcome Measures

Primary Outcome Measures

  1. Children's State Anxiety Scale (CSA) [4 months]

    This scale was developed by Ersig et al. in 2013 to measure the state anxiety of children in the 4-10 age group (Ersig et al, 2013). The Turkish validity and reliability study of the scale was conducted by Gerçeker et al. in 2017. The scale is designed as a thermometer with a light bulb at the bottom and evenly spaced horizontal lines going up. Each horizontal line on the thermometer represents one point, and the bulb treasure at the bottom is 0 points. As you move up, the score obtained from the scale increases, and a maximum of 10 points is obtained. A score of 0 on the scale indicates no anxiety and a score of 10 indicates the highest anxiety. The scale can be used by creating different scenarios for children who understand the thermometer analogy and those who do not.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Children who are between the ages of 4-6, have no pain, have been hospitalized for at least two days, are receiving IV treatment, and whose parents approve of participating in the study will be included in the study.
Exclusion Criteria:
  • Children with mental retardation who underwent surgical procedures will not be included in the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Adiyaman University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maksude YILDIRIM, Dr., Adiyaman University
ClinicalTrials.gov Identifier:
NCT06052761
Other Study ID Numbers:
  • HRÜ/23.15.05
First Posted:
Sep 25, 2023
Last Update Posted:
Sep 25, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 25, 2023