Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600113
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-06
Brief Title:
Effect of Educational Intervention on Childrens Anxiety
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating Effectiveness of Different Educational Methods on the Anxiety of Children Undergoing Anaesthesia - a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINA
Brief Summary:
The aim of this randomized controlled trial is to evaluate the effectiveness of an educational health game intervention for children undergoing anesthesia from the perspective of childrens anxiety Participants are divided into three groups one plays an educational game another gets similar educational material story on a website and the third receives usual care Anxiety will be evaluated with a standard assessment tool at the medical centre and parents answer questionnaires about themselves and their child The study is an important step into innovation in the field of patient education where computer games are used to disseminate information teach salvation and promote faith in the childs own ability and courage The study will provide important information on childrens anxiety for anaesthesia and what the effects of the computer game are compared to other educational methods
Detailed Description:
This study is a randomized controlled trial This study will evaluate the effectiveness of an educational health game intervention for children undergoing anesthesia from the perspective of childrens anxiety The data will be collected from children 4-8 years old and their parent or guardian at four different time points the baseline post1 post-2 and post 3-intervention
The sample size was calculated by statistician using power calculations According to the calculations the targeted sample size is in total 150 children 50 per each arm in Finland and Iceland
Participants are recruited from daycare surgery wards in university hospitals or hospitals where children undergo various procedures under anesthesia The recruitment will be agreed separately with the hospital and hospital workers
Data will be collected in four different time points
1 Before the intervention baseline Questionnaires for parent the childs temperament is measured with Child Behaviour Questionnaire CBQ Rothbart et al 2001 the anxiety of parent is measured with the State-trait Anxiety Inventory STAI trait part Spielberger 1983 and background information of the child and parents
2 After the baseline questionnaires children are randomized to three groups Group A plays an educational mobile game Group B similar educational material on a website than in the health game and Group C the usual care receives information from the health personnel for preparation for the anesthesia
3 At the hospital Questionnaire for parent Parents answers the anxiety of parent STAI state part Nurse observes childs anxiety in hospital using The Modified Yale Preoperative Anxiety Scale mYPAS short form mYPAS-SF Jenkins et al 2014 in the waiting room before the anesthesia post 1 while the child is prepared for anesthesia and right before the induction of anesthesia post 2 Nurse 2 also observes weather the child is particularly crying or calm when waking up The nurse will collect information from the childs medical records for the study such as the procedure the child has had and the reason for the procedure premedication etc
4 After the anesthesia post 3 Questionnaire for parent 2-4 days after the operation questions regarding the experience of anesthesia
The sample size was calculated by statistician using power calculations According to the calculations the targeted sample size is in total 150 children 50 per each arm in Finland and Iceland
Participants are recruited from daycare surgery wards in university hospitals or hospitals where children undergo various procedures under anesthesia The recruitment will be agreed separately with the hospital and hospital workers
Data will be collected in four different time points
1 Before the intervention baseline Questionnaires for parent the childs temperament is measured with Child Behaviour Questionnaire CBQ Rothbart et al 2001 the anxiety of parent is measured with the State-trait Anxiety Inventory STAI trait part Spielberger 1983 and background information of the child and parents
2 After the baseline questionnaires children are randomized to three groups Group A plays an educational mobile game Group B similar educational material on a website than in the health game and Group C the usual care receives information from the health personnel for preparation for the anesthesia
3 At the hospital Questionnaire for parent Parents answers the anxiety of parent STAI state part Nurse observes childs anxiety in hospital using The Modified Yale Preoperative Anxiety Scale mYPAS short form mYPAS-SF Jenkins et al 2014 in the waiting room before the anesthesia post 1 while the child is prepared for anesthesia and right before the induction of anesthesia post 2 Nurse 2 also observes weather the child is particularly crying or calm when waking up The nurse will collect information from the childs medical records for the study such as the procedure the child has had and the reason for the procedure premedication etc
4 After the anesthesia post 3 Questionnaire for parent 2-4 days after the operation questions regarding the experience of anesthesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None