- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05775640
The Effect of Serious Game on Hospitalized Children's Anxiety, Fear, Knowledge, and Anxiety Levels in Their Parents
PhD(c), RN, Lecturer
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hilal Parlak Sert, lecturer
- Phone Number: 90 (258) 296 4396
- Email: hilalsert@pau.edu.tr
Study Locations
-
-
-
Denizli, Turkey, 20160
- Recruiting
- Pamukkale Universitesi
-
Contact:
- Phone Number: 05053084403
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention group
|
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.
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
applied on the first day of 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.
|
up to 3 days
|
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
|
up to 3 days
|
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
|
up to 3 days
|
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
|
up to 3 days
|
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.
|
up to 3 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- pau-parlaksert-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Serious Game on Hospitalized Children
-
Istituto di Farmacologia Traslazionale - sede di...Not yet recruitingAsthma in Children | Children, Only | Serious Game
-
Shanghai Jiao Tong University School of MedicineCompletedEducational Problems | Serious Game | Augmented RealityChina
-
Acibadem UniversityRecruitingVirtual Reality | Serious Game | Advanced Cardiac Life SupportTurkey
-
Maastricht University Medical CenterCompletedPhysical Activity | Child Behavior | Serious Game | School InterventionNetherlands
-
Ramsay Générale de SantéEuropean Clinical Trial Experts NetworkRecruitingSerious Game | Dysexecutive SyndromeFrance
-
Seattle Children's HospitalCompletedHospitalized ChildrenUnited States
-
Children's Hospital of Fudan UniversityCompletedVascular Access Devices | Children,HospitalizedChina
-
Istanbul Medipol University HospitalCompletedRehabilitation | Rotator Cuff Tears | Serious GameTurkey
-
Children's Hospital of Fudan UniversityTongji Hospital; Chengdu Women's and Children's Central Hospital; Xiamen Children... and other collaboratorsRecruitingInfections | Infusion | Children,HospitalizedChina
-
Gümüşhane UniversıtyNot yet recruitingEducation | Serious Game | Operating Room Nursing | Surgical Instrument | Sterile Dressing
Clinical Trials on serious game
-
Institut National de la Santé Et de la Recherche...Recruiting
-
Laval UniversityUniversité Catholique de LouvainRecruitingAging | Older Adults | Aging WellCanada
-
mona mlikaCompleted
-
Université Paris-SudCompleted
-
Institut National de la Santé Et de la Recherche...Completed
-
Gümüşhane UniversıtyNot yet recruitingEducation | Serious Game | Operating Room Nursing | Surgical Instrument | Sterile Dressing
-
National Taiwan University HospitalEnrolling by invitation
-
Ramsay Générale de SantéEuropean Clinical Trial Experts NetworkRecruitingSerious Game | Dysexecutive SyndromeFrance
-
Assistance Publique - Hôpitaux de ParisRecruitingType 1 DiabetesFrance
-
VU University of AmsterdamCompleted