Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399016
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-28
Brief Title:
Augmented Reality Applied Book Reading in the Preoperative Period
Sponsor:
Celal Bayar University
Organization:
Celal Bayar University
Study Overview
Official Title:
The Effect of Reading a Book With Augmented Reality Application on the Level of Fear and Anxiety in Children in the 7-12 Age Group in the Preoperative Period
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Non-pharmacological methods such as multimedia applications and visual and auditory technological tools are used to create a more enjoyable experience by reducing childrens fear and anxiety and distracting them in the preoperative period With the latest developments in technology live immersive augmented and virtual reality systems are seen to be included and used in preoperative preparation training especially for pediatric patients One of the applications of these innovative technologies that has attracted attention recently is augmented reality technology The original value of this study is to reduce the fear and anxiety levels experienced by children reading books in the preoperative period with the application of augmented reality which is a developing promising and easily accessible technology The method of this study consists of two groups an augmented reality applied book reading group and a control group In the preoperative period for both groups a survey will be administered to the child and the accompanying parent using the Child and Family Introductory Data Form which includes sociodemographic characteristics approximately 1 hour before the surgery In addition the child himself will be asked to score the Child Anxiety Scale-State scale to determine the level of anxiety about the surgery and the child himself the parent and the researcher will be asked to score the Child Fear Scale to determine the childs level of fear about the surgery The book reading group with augmented reality application will be asked to read the voiced and animated book titled One Child One Miracle accompanied by an application downloaded free of charge from Google Play or IOS to their mobile phone or tablet The storybook will be presented to the children in this application group in three dimensions with the help of a mobile phone or tablet Children in the control group will read the same book without using the augmented reality application After reading the book for both groups the children will be asked to rate their fear and anxiety levels again using the same scales This research is a randomized controlled and experimental study The adequacy of the sample size in the study G It was calculated using the Power-3192 program In the power analysis conducted for the sample and power calculation of the experimental study with the application and control groups it was decided to study with 30 children for each group
Detailed Description:
During hospitalization and exposure to medical procedures and surgical procedures children perceive themselves as different from other children and experience feelings of inadequacy and feel hindered Especially for school-age children aged 7-12 hospitalization means a process full of worries that cause anxiety and fear In a study investigating the feelings of hospitalized children aged 7-12 about hospital and disease it was observed that children defined the hospital as a place where pain and painful procedures are performed most often causing both themselves and their parents to be upset and where they experience fear and anxiety Because the hospital environment staff materials used and procedures to be performed are reflected as a state of uncertainty for every group of children hospitalized This uncertainty they experience may affect the childs adaptation to the hospital and treatment his communication with healthcare personnel and his future hospital experience Having an additional surgical intervention on the child in addition to hospitalization causes more stress and affects the child more both psychologically and physiologically In a study the psychosocial symptoms of 360 hospitalized children aged 6-12 were examined in terms of some variables It has been determined that more than half of the children develop anxiety due to hospitalization along with regression communication difficulty hopelessness and anger behaviors In another study examining postoperative behavioral changes in Chinese children who underwent hypospadias surgery it was determined that three-fifths of the children showed behavioral changes that lasted for several weeks after surgery
The success of surgery in children is not only related to the importance of the techniques and skills applied but also to the preparation of the child and the parent and meeting the care needs in the preoperative period Preparing the child patient appropriately in the preoperative period prevents him from experiencing both behavioral and physiological symptoms of fear and anxiety Studies have shown that more than 60 of children who undergo surgery experience anxiety before surgery and anesthesia However in children who were psychologically affected in the preoperative period maladaptive behavioral changes such as anxiety eating and sleeping disorders nightmares enuresis and tantrums occurred in the postoperative period Some intervention practices have been developed to reduce preoperative fear and anxiety in children and to prevent anxiety-related behavioral changes These practices include various behavioral preparation programs used to distract from nonpharmacological practices Such approaches help children to divert their attention from fearful and painful procedures by keeping them active In methods of diverting attention Methods such as daydreaming listening to music hypnosis relaxation techniques breathing control biofeedback exercises watching videos reading books telling stories and games are used In a study it was observed that children aged 4-10 years of age reduced their stress their parents anxiety and postoperative delirium by providing distraction via tablets and phones in the preoperative period and increased cooperation with medical personnel during anesthesia induction The preparations to be made according to the childs age period characteristics and understanding capacity should be explained to the child so that heshe does not feel afraid Because preoperative anxiety is associated with an increased incidence of delirium pain and postoperative maladaptive behavior in the child It can also manifest itself in various ways such as agitation crying shaking struggle and escape behaviors Therefore the main goal in preparing for the surgery process is to maintain the child-parent relationship reduce fears and anxiety arising from the unknown and psychologically support the child and parents Preoperative interventions have been increasingly used in hospital settings over the past few years It has been observed that fear and anxiety arising from the preoperative period in children video glasses video displaying smartphones and tablets reduce postoperative delirium
Hypothesis of the Research
Hypothesis 1 H1 Reading books with augmented reality application in the preoperative period reduces the level of fear in children aged 7-12
Hypothesis 2 H1 Reading books with augmented reality application in the preoperative period reduces the anxiety level in children aged 7-12
The success of surgery in children is not only related to the importance of the techniques and skills applied but also to the preparation of the child and the parent and meeting the care needs in the preoperative period Preparing the child patient appropriately in the preoperative period prevents him from experiencing both behavioral and physiological symptoms of fear and anxiety Studies have shown that more than 60 of children who undergo surgery experience anxiety before surgery and anesthesia However in children who were psychologically affected in the preoperative period maladaptive behavioral changes such as anxiety eating and sleeping disorders nightmares enuresis and tantrums occurred in the postoperative period Some intervention practices have been developed to reduce preoperative fear and anxiety in children and to prevent anxiety-related behavioral changes These practices include various behavioral preparation programs used to distract from nonpharmacological practices Such approaches help children to divert their attention from fearful and painful procedures by keeping them active In methods of diverting attention Methods such as daydreaming listening to music hypnosis relaxation techniques breathing control biofeedback exercises watching videos reading books telling stories and games are used In a study it was observed that children aged 4-10 years of age reduced their stress their parents anxiety and postoperative delirium by providing distraction via tablets and phones in the preoperative period and increased cooperation with medical personnel during anesthesia induction The preparations to be made according to the childs age period characteristics and understanding capacity should be explained to the child so that heshe does not feel afraid Because preoperative anxiety is associated with an increased incidence of delirium pain and postoperative maladaptive behavior in the child It can also manifest itself in various ways such as agitation crying shaking struggle and escape behaviors Therefore the main goal in preparing for the surgery process is to maintain the child-parent relationship reduce fears and anxiety arising from the unknown and psychologically support the child and parents Preoperative interventions have been increasingly used in hospital settings over the past few years It has been observed that fear and anxiety arising from the preoperative period in children video glasses video displaying smartphones and tablets reduce postoperative delirium
Hypothesis of the Research
Hypothesis 1 H1 Reading books with augmented reality application in the preoperative period reduces the level of fear in children aged 7-12
Hypothesis 2 H1 Reading books with augmented reality application in the preoperative period reduces the anxiety level in children aged 7-12
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