Serious Game on Hospitalized ChildrenNCT05775640
The Effect of Serious Game on Hospitalized Children's Anxiety, Fear, Knowledge, and Anxiety Levels in Their Parents
A study testing serious game in people with Serious Game on Hospitalized Children, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Serious Game on Hospitalized Children
- What is being tested?
- serious game
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale Universitesi
Denizli, 20160
05053084403
About this study
Official title: 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.
- Conditions
- Serious Game on Hospitalized Children
- Being tested
- serious game
- Keywords
- Serious Game, Anxiety, Fear, Hospitalized Children, Parent
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serious gameBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | 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. |
| intervention group | Experimental | Not described Receives: Behavioral: serious game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic data collection form
It was developed the sociodemographic characteristics of the children and parents participating in the study
Measured: applied on the first day of study
Clinical Information Form
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.
Measured: up to 3 days
The child medical fears scale
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
Measured: up to 3 days
State-Trait Anxiety Inventory for Children (STAI-CH)
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
Measured: up to 3 days
State-Trait Anxiety Inventory for Adults(STAI)
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
Measured: up to 3 days
Game Evaluation Questionnaire
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.
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Oct 2022
- Primary completion26 Oct 2022
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious Game on Hospitalized ChildrenStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind pre-post test randomized controlled design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal PARLAK SERT, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775640
- Sponsor's protocol ID
- pau-parlaksert-001
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhD(c), RN, Lecturer
- ClinicalTrials.gov ID
- NCT05775640
- Acronym / sponsor ID
- pau-parlaksert-001
- Conditions
- Serious Game on Hospitalized Children
- Keywords
- Serious Game, Anxiety, Fear, Hospitalized Children, Parent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blind pre-post test randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –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. |
| intervention group | Experimental | Behavioral: serious game |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Daily and hospitalizations less than three days
- Repeated hospitalizations
- Speech, comprehension and mental problems
- Being treated for an oncological problem
- applied for trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serious gameThe 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. | Behavioural | intervention group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serious game in people with Serious Game on Hospitalized Children, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilal Parlak Sert, lecturer (90 (258) 296 4396, hilalsert@pau.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sociodemographic data collection form (time frame: applied on the first day of study). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.