Augmented Reality Applied Book Reading in the Preoperative Period

NCT06399016 | Not Yet Recruiting

• 1 other identifier: Augmented Reality Application
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Preoperative Anxiety

Keywords

Child; fear; anxiety; operating theater tour; augmented reality

Outcome Measures

Primary Outcomes (1)

• Sociodemographic Information Form

  A total of 23 questions are the researcher prepared the form in line with the literature. The form is include two parts. One of theparts are include items questioning the child's diagnosis, length of hospital stay, sex, and whether he or she had been hospitalized or had surgery previously. The forms will filled by the researcherusing the face-to-face interview method.

  in the preoperative period.

Secondary Outcomes (2)

• Determining the preoperative anxiety scores of children

  in the preoperative period.

• Determining the preoperative fear scores of children

  in the preoperative period.

Study Arms (2)

Group 1: Augmented Reality Applied Book Reading Group

EXPERIMENTAL

Children included in this group will be asked to read books supported by augmented reality technology. Approximately 1 hour before the surgery, a survey will be administered to the child and the accompanying parent using the "Child and Family Introductory Data Form", which includes sociodemographic characteristics. 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. Data collection will take approximately 10 minutes in total. Immediately afterwards, the researcher will ask the child to read the book 'One Child, One Miracle', which is a technology-supported augmented reality application, with the help of an application previously downloaded free of charge from Google Play or IOS to a mobile phone or tablet.

Device: augmented reality book

Group 2: Control Group

EXPERIMENTAL

In the preoperative period, the researcher will conduct a survey on the morning of the surgery day, approximately 1 hour before the surgery, using the "Child and Family Introductory Data Form", which includes the sociodemographic characteristics of the child and the accompanying parent. 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. Data collection will take approximately 10 minutes in total. Immediately afterwards, the child will be asked by the researcher to read the story book "One Child, One Miracle". This group will be asked to just read the book without turning on the book's augmented reality feature. Afterwards, using the same scales, children will score the "CAS" scales, and the child, parent and researcher will score the "CFS" scales.

Device: book

Interventions

augmented reality book DEVICE

The story will be presented to the children in this application group in three dimensions. The augmented reality application will be supported by the researcher as it must be used under the supervision of an adult. When the tablet or phone is held to the pages of the book, the animations of these pages are displayed on the screen with sound. While the animation opens automatically when we hold the phone or tablet, the story can be listened to aloud at the same time.

Also known as: Augmented reality applied book titled 'One Child, One Miracle'

Group 1: Augmented Reality Applied Book Reading Group

book DEVICE

This group will be asked to just read the book without turning on the augmented reality feature of the book.

Also known as: 'One Child, One Miracle'

Group 2: Control Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

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

Sponsors & Collaborators

• Celal Bayar University: lead

Study Sites (2)

Manisa Hafsa Sultan Hospital

Manisa, Turkey (Türkiye)

Location

Surgical clinic of Manisa Celal Bayar University Hospital

Manisa, Turkey (Türkiye)

Location

Related Publications (1)

• Sekeler A, Karaarslan D, Gulmez FB. Effects of reading augmented reality storybook versus normal storybook reading on preoperative fear and anxiety levels of children in the age group of 7-12 years: A randomized controlled trial. J Pediatr Urol. 2025 Oct;21(5):1295-1305. doi: 10.1016/j.jpurol.2025.02.025. Epub 2025 Feb 25.

  PMID: 40074655 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Duygu Karaarslan

CONTACT

05062146960; duygukrrsln@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In the process of assignment of children into groups, randomization is achieved in the computer by stratifying them in terms of sex and age variables (https://www.randomizer.org/).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 3, 2024
• Study Start: May 10, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 30, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

TU (2)