Ignite Creation Date:
2024-05-06 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05279976
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2022-02-23
Brief Title:
Reducing the Anxiety of Children and Their Parents in the Preoperative Process
Sponsor:
Akdeniz University
Organization:
Akdeniz University
Study Overview
Official Title:
The Effect of Visualized Education and Distraction in the Preoperative Process on Reducing the Anxiety of Children and Their Parents a Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is emphasized in the studies that the child and parent anxiety that occurs in pediatric surgery should be prevented or reduced According to previous studies one way to reduce child and parent anxiety in the preoperative process is to inform the child and family with preoperative family-centered activities Teaching children anxiety coping skills with the involvement of their parents can reduce preoperative anxiety This study was planned to evaluate the effect of visualized education and kaleidoscope distraction on children and parents anxiety on the day of surgery in the preoperative period
Detailed Description:
Aim This study was planned to evaluate the effect of visualized education and kaleidoscope distraction on children and parents anxiety on the day of surgery in the preoperative period
Method This study was planned as a randomized controlled trial The sample of the study will consist of 105 children aged 5-12 who will be operated on at Akdeniz University Hospital and their parents Randomization result Education group35 distraction group35 and control group35 children a total of 105 children in 3 groups and their parents were planned to be included in the study Child and parent information form will be used to collect data Modified Yale Preoperative Anxiety Scale will be used to collect data in child sample and Spielberger State Anxiety Scale will be used to collect data in parent sample
Intervention and Data Collection The study was planned to be implemented in the Akdeniz University Hospital Operating Room Patient Preparation Room after the approval of the Akdeniz University Ethics Committee and the written permission of the Akdeniz University Hospital It will be ensured that the child and parent are together during the initiatives No intervention will be applied to the parents included in the sample of the study After explaining the purpose of the study to the child and parent who agreed to participate in the study and obtaining consent randomization will be performed The child assigned to intervention group 1 will be told the operation preparation room and the pre-anesthesia process through the picture booklet prepared immediately after the pre-test first measurement Children included in this group will be provided to touch the bonnet mask gloves and self-inflated balloon representing the ambu device and the questions of the child and the parent will be answered Children and parents included in this group will form intervention group 1 35 children 35 parents
The child who was assigned to intervention group 2 as a result of randomization will be provided with the use of kaleidoscope which is a distraction technique immediately after the pre-test first measurement The second measurement will be made immediately after the child wears the surgical gown Children and parents included in this group will form intervention group 2 35 children 35 parents
Children randomized to the control group will not receive any intervention A pre-test first measurement will be made for the child who is assigned to the control group as a result of randomization and the second measurement will be made immediately after the child wears the surgical gown Children and parents included in this group will form control group 35 children 35 parents
After all post-test second measurement applications are completed the effectiveness of the interventions and their comparison with each other will be evaluated After the post-test application of the research is completed the data obtained will be analyzed using the Statistical Package of Social Science SPSS 230 software package program The process of evaluating the data will be carried out with the support of a statistician
Method This study was planned as a randomized controlled trial The sample of the study will consist of 105 children aged 5-12 who will be operated on at Akdeniz University Hospital and their parents Randomization result Education group35 distraction group35 and control group35 children a total of 105 children in 3 groups and their parents were planned to be included in the study Child and parent information form will be used to collect data Modified Yale Preoperative Anxiety Scale will be used to collect data in child sample and Spielberger State Anxiety Scale will be used to collect data in parent sample
Intervention and Data Collection The study was planned to be implemented in the Akdeniz University Hospital Operating Room Patient Preparation Room after the approval of the Akdeniz University Ethics Committee and the written permission of the Akdeniz University Hospital It will be ensured that the child and parent are together during the initiatives No intervention will be applied to the parents included in the sample of the study After explaining the purpose of the study to the child and parent who agreed to participate in the study and obtaining consent randomization will be performed The child assigned to intervention group 1 will be told the operation preparation room and the pre-anesthesia process through the picture booklet prepared immediately after the pre-test first measurement Children included in this group will be provided to touch the bonnet mask gloves and self-inflated balloon representing the ambu device and the questions of the child and the parent will be answered Children and parents included in this group will form intervention group 1 35 children 35 parents
The child who was assigned to intervention group 2 as a result of randomization will be provided with the use of kaleidoscope which is a distraction technique immediately after the pre-test first measurement The second measurement will be made immediately after the child wears the surgical gown Children and parents included in this group will form intervention group 2 35 children 35 parents
Children randomized to the control group will not receive any intervention A pre-test first measurement will be made for the child who is assigned to the control group as a result of randomization and the second measurement will be made immediately after the child wears the surgical gown Children and parents included in this group will form control group 35 children 35 parents
After all post-test second measurement applications are completed the effectiveness of the interventions and their comparison with each other will be evaluated After the post-test application of the research is completed the data obtained will be analyzed using the Statistical Package of Social Science SPSS 230 software package program The process of evaluating the data will be carried out with the support of a statistician
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None