The Effect of Serious Game on Hospitalized Children's Anxiety, Fear, Knowledge, and Anxiety Levels in Their Parents

NCT ID: NCT05775640

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-03-30

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.

Conditions

Serious Game on Hospitalized Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

control group

Sociodemographic data collection form, Clinical Information Form, The child medical fears scale, State and Trait Anxiety Inventory for Children were administered to the children in the control group, and the State-Trait Anxiety Inventory (STAI) was administered to the parents of the children in the control group on the 0th day of hospitalization. The standard clinical hospitalization process was not interfered with. On the third day of hospitalization, the children in the control group were administered the Clinical Information Form, the The child medical fears scale, the State and Trait Anxiety Inventory for Children, and the State-Trait Anxiety Inventory (STAI) for their parents. After the study, the link of the game was sent to the control group so that they could play the game in order to avoid ethical problems.

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention group

Group Type: EXPERIMENTAL

serious game

Intervention Type: BEHAVIORAL

The forms were applied to the children in the experimental group and the parents of the children on the 0th day of hospitalization. After the forms were applied, a serious game developed by the researchers was played. Children were given access to the game by giving a game link. The game can be played on digital platforms such as computers, tablets, etc. For children who do not have an electronic device, the game was downloaded to the computer in the hospital and the children were allowed to play. On the third day of hospitalization, the children and their parents were surveyed again and the Game Evaluation Questionnaire was filled. Access to the game will be closed at the end of the study.

Interventions

serious game

The forms were applied to the children in the experimental group and the parents of the children on the 0th day of hospitalization. After the forms were applied, a serious game developed by the researchers was played. Children were given access to the game by giving a game link. The game can be played on digital platforms such as computers, tablets, etc. For children who do not have an electronic device, the game was downloaded to the computer in the hospital and the children were allowed to play. On the third day of hospitalization, the children and their parents were surveyed again and the Game Evaluation Questionnaire was filled. Access to the game will be closed at the end of the study.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Hilal PARLAK SERT

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pamukkale Universitesi

Denizli, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Hilal Parlak Sert, lecturer

Role: CONTACT

hilalsert@pau.edu.tr

90 (258) 296 4396

Facility Contacts

Role: primary

05053084403

Other Identifiers

pau-parlaksert-001

Identifier Type: -

Identifier Source: org_study_id