Child in Hospital and Playing

NCT06052761 | Completed

• 1 other identifier: HRÜ/23.13.05
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Child in Hospital

Outcome Measures

Primary Outcomes (1)

• Children's State Anxiety Scale (CSA)

  This scale was developed in 2013 to measure the state anxiety of children in the 4-10 age group. The Turkish validity and reliability study of the scale was conducted 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.

  4 months

Study Arms (2)

Making Toys from Medical Materials

EXPERIMENTAL

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.

Device: Making Toys from Medical Materials

Control group

NO INTERVENTION

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.

Interventions

Making Toys from Medical Materials DEVICE

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.

Making Toys from Medical Materials

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children with mental retardation who underwent surgical procedures will not be included in the study.

Sponsors & Collaborators

• Adiyaman University: lead

Study Sites (1)

Adıyaman University Faculty of Health Sciences

Adıyaman, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 25, 2023
• Study Start: February 12, 2024
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-02

Locations

TU (1)