Clinical trial NCT05775640: The Effect of Serious Game on Hospitalized Children's Anxiety, Fear, Knowledge, and Anxiety Levels in Their Parents
Official title: PhD(c), RN, Lecturer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Serious Game on Hospitalized Children
Keywords: Serious Game
Anxiety
Fear
Hospitalized Children
Parent
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 64
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind pre-post test randomized controlled design
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Sociodemographic data collection form
timeFrame: applied on the first day of study
measure: Clinical Information Form
timeFrame: up to 3 days
measure: The child medical fears scale
timeFrame: up to 3 days
measure: State-Trait Anxiety Inventory for Children (STAI-CH)
timeFrame: up to 3 days
measure: State-Trait Anxiety Inventory for Adults(STAI)
timeFrame: up to 3 days
measure: Game Evaluation Questionnaire
timeFrame: up to 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale Universitesi
Study officials:
References: