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Clinical Trials/NCT05775640
NCT05775640
Recruiting
Not Applicable

PhD(c), RN, Lecturer

Pamukkale University1 site in 1 country64 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Serious Game on Hospitalized Children
Sponsor
Pamukkale University
Enrollment
64
Locations
1
Primary Endpoint
Sociodemographic data collection form
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Children may view hospitalization as a stressful experience. Children who are hospitalized show high levels of anxiety symptoms. During the hospitalization process, the family of the child as well as the children experience anxiety and stress. These fears and concerns are based on inadequate preparation for hospitalization and lack of knowledge.

Interventions to reduce the fear and anxiety of children during hospitalization include classical methods such as developing booklets and drawing pictures. While various benefits of these methods have been demonstrated, computer and web-based interventions have been shown to be the best way to prepare children for hospitalization. When computer and web-based interventions are examined, it is seen that they mostly focus on anxiety and pain control in children who are hospitalized for the operation process. More studies are needed to prepare hospitalized children for clinical procedures, to introduce the hospital environment, and to introduce the tools used in the hospital with computer and web-based interventions.

The research is a randomized controlled experimental study consisting of three stages. In the first stage of the research, serious game was developed. In the second stage, a randomized controlled study with experimental control group design was carried out. In the third stage, children's views and perceptions about serious play were determined and the effectiveness of the game was evaluated. The population of the research consisted of children aged 8-12, hospitalized in Pamukkale University Hospitals Pediatrics Service between October 2022 and February 2023. The G. Power program was used in the sample calculation and the sample size was calculated as 53 (Effect size 0.50, Power 95%). Considering that there may be data loss while collecting the data, it was increased by 20% and the experimental group was determined as 32 and the control group as 32.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
March 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hilal PARLAK SERT

lecturer

Pamukkale University

Eligibility Criteria

Inclusion Criteria

  • accept to participate in the study
  • children hospitalized for the first time
  • Inpatient treatment between the ages of 8-12-
  • Comprehension and speech impairment
  • without any mental disability
  • Children and parents whose hospitalization is planned for at least three days

Exclusion Criteria

  • Daily and hospitalizations less than three days
  • Repeated hospitalizations
  • Speech, comprehension and mental problems
  • Being treated for an oncological problem
  • applied for trauma
  • Children and parents who did not agree to participate in the study

Outcomes

Primary Outcomes

Sociodemographic data collection form

Time Frame: applied on the first day of study

It was developed the sociodemographic characteristics of the children and parents participating in the study

Clinical Information Form

Time Frame: up to 3 days

includes information about the procedures, procedures, equipment and healthcare professionals used in the clinic.The form developed by the researchers includes information about the procedures, procedures, equipment and healthcare professionals used in the clinic. It consists of multiple-choice and 3-option questions.

The child medical fears scale

Time Frame: up to 3 days

It is a scale to measure children's fears about medical procedures and practices.The total number of questions of the scale is 29, the lowest score obtained from the scale is 29, and the highest score is 87. The scale is a Likert type scale with three choices. Those who scored (0-29) on the scale were never afraid; (29-58) points are

State-Trait Anxiety Inventory for Children (STAI-CH)

Time Frame: up to 3 days

It is used to measure the level of state and trait anxiety in children aged 9-12 who have reached literacy level.It aims to measure persistent individual differences as well as anxiety propensity. There are 20 items in total in the scale. The lowest score that can be obtained is 20, and the highest score is 60. Evaluates how the child usually feels according to the

State-Trait Anxiety Inventory for Adults(STAI)

Time Frame: up to 3 days

It is one of the methods used to evaluate the level of anxiety.It consists of two subscales of 20 questions about state and trait anxiety. All questions are in a four-point Likert type. The scores of both subscales are summed separately and a total score between 20 and 80 is obtained. Higher scores indicate a higher

Game Evaluation Questionnaire

Time Frame: up to 3 days

The developed game is prepared for children's evaluation.The questionnaire was developed in line with the literature. The survey consists of 2 parts. In the first part, the usefulness of the game is evaluated, and in the second part, the game content is evaluated.

Study Sites (1)

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