Clinical trial NCT06399016: Augmented Reality Applied Book Reading in the Preoperative Period
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preoperative Anxiety
Keywords: Child
fear
anxiety
operating theater tour
augmented reality
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: During the preoperative period, children who meet the inclusion criteria of the study will be determined from the list of children who will undergo surgery. Before the research, children who will undergo surgery and their parents will be informed on the morning of the surgery, approximately 1 hour before the surgery, and their written and verbal consent will be obtained. On the morning of the surgery day, the "Child and Family Introductory Data Form" will be filled out by children in the 7-12 age group and their parents who meet the inclusion criteria and agree to participate in the research. The child himself/herself will be asked to score the level of surgery-related anxiety using the "CAS" score, and the child, the parent, and the researcher will be asked to score the child's fear level regarding the surgery using the "CFS" score.

The application material to be used in the research is the story book titled 'One Child, One Miracle', which includes an augmented reality application.
Primary purpose: SUPPORTIVE_CARE

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 children's 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 child's 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-3.1.9.2" 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 child's 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 child's age, period characteristics and understanding capacity should be explained to the child so that he/she 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.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 7-12
* Children who will undergo surgery for the first time will be included
* No communication problems (vision, hearing, mental),
* Both his/her parents volunteer to participate in the research, and their parents give written and verbal consent,

Exclusion Criteria:

* Children have genetic or congenital disease,
* Children have a chronic disease
* Children have previous surgery

Primary outcomes:
measure: Sociodemographic Information Form
timeFrame: in the preoperative period.
Secondary outcomes:
measure: Determining the preoperative anxiety scores of children
timeFrame: in the preoperative period.
measure: Determining the preoperative fear scores of children
timeFrame: in the preoperative period.
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Manisa Hafsa Sultan Hospital
city: Manisa
country: Turkey
facility: Surgical clinic of Manisa Celal Bayar University Hospital
Study officials:
References: