1.1

Study aim and hypothesis

This study was performed to determine how VR glasses utilized in extirpation treatment and tooth extraction performed with local anesthesia affected fear and anxiety in pediatric patients aged between seven and ten. The hypotheses of this research are as follows.

2.1

Study design and sample

The research was designed as a randomized controlled experimental study. Seven-to-eight-year-old children who presented to the pediatric dental clinic of an ODH center affiliated with the Ministry of Health in the east of Turkey for tooth extraction and extirpation treatment made up the study population. The number of samples to be recruited for each group was estimated on the GPOWER 3.1 software as 33 for dependent groups t -test analysis, by taking a power value of 80%, a significance level of 0.05, an effect size of 0.15. Considering 10% attrition, it was planned to sample a total of 80 children, 40 in each group. Eventually, a total of 120 children, 60 in each group, were included in the research to reveal the association of the variables more clearly and because the number of volunteering children was high. This study was carried out between September and December 2023. The CONSORT checklist was used in the study [ ]. According to the inclusion criteria, seven-to-eight-year-old children who had no cognitive development problems, could read and write, volunteered to join the research, and submitted written consent and their fathers and/or mothers were taken to the research. Exclusion criteria were determined as children who quit during the research, did not agree to join the study, or had hearing and sight problems that might hinder the use of VR glasses.

2.2

Randomization

For the randomization of the study, stratified randomization that included tooth extraction and extirpation treatment in 7-10-year-old children was applied, which was followed by quadruple block randomization using a simple random numbers table (EECC, ECCE, CECE, DKDK, CCEE, CEEC). The sample comprised 135 children. These children were evaluated for eligibility and 12 were excluded due to refusing to participate in the study (n = 5) and sight and hearing problems (n = 7). Three EG children wanted to remove their VR glasses while the intervention was in progress. The final sample consisted of 120 children. Fig. 1 shows the CONSORT chart of the research.

CONSORT flow chart diagram of the study.

2.3

Measurements

2.4

Application tools

Virtual Reality Glasses (VR) were used as the application tool in the research. Participants participated in the experiment using Samsung Gear VR and Samsung Galaxy S7 mobile phones. Samsung Gear VR is a head-mounted virtual reality device that provides an immersive virtual reality. There is a place for a headset to provide immersive VR. A list of 10 cartoons, some of which are the same for age and gender groups, was prepared to be presented to expert opinion. The cartoons selected for the 3D virtual environment for girls aged 7–10 are; Elsa Snow Queen, Happy Bear, Rafadan Tayfa, Esrarengiz Kasaba, Masha and Kocaayı, and the cartoons selected for boys aged 7–10 are Rafadan Tayfa, Dinosaur T-Rex, Happy Bear, Esrarengiz Kasaba, SpongeBob. A list of a total of 10 cartoons, some of which are the same for age and gender groups, was prepared to be submitted to eight experts, including three from the field of child health and disease nursing, one expert in the field of pediatric dentistry and four psychologists, to calculate the content validity ratio (CVR) and the content validity index (CVI). They were asked to rate each item using the following options: “appropriate,” “appropriate but should be corrected,” and “not appropriate.” As a result of expert opinions, the item-level content validity index was found to range from 0.89 to 1.00, and the list-level (total) content validity index was determined to be 0.97. Both the item-level and the scale-level content validity indices are expected to be > 0.80 [ ]. Index values showed that interrater agreement was established, the list was appropriate for the objective, and that content validity was ensured. The cartoons in the content-validated list were downloaded to the researcher’s mobile phone. The children in the study watched the cartoon of their choice through virtual reality glasses connected to the mobile phone with the cartoons.

2.5

Implementation of the study

The child and parent descriptive data form was filled out after the children’s consent was taken. Then, the CAS-S and the CFS were applied to the EG children 10 min before the intervention. Both the children and the researcher evaluated the measures. After these preliminary tests were carried out, a cartoon that the child liked and wanted to watch during the procedure was opened from the smart phone records of the experimental group, placed on the VR glasses and placed on the child’s eyes. The experimental group was shown cartoons with VR glasses during the procedure. After the procedure, the VR glasses were removed and the final test was performed 10 min after the procedure was completed. After the preliminary tests of the control group were performed, standard treatment practices were continued throughout the procedure. The final test was administered 10 min after the standard treatment was completed. In addition, before starting the procedure, the gums or the inside of the cheeks of the children in both the experimental and control groups were numbed with local anesthetic. The teeth of the children with completely decayed teeth were extracted, and if necessary, filling material was placed in the decayed and weakened parts of the teeth and the remaining tooth tissue.

2.6

Data analysis

Statistical calculations were done on the SPSS (V24.0) software. The normality of the data was evaluated with the Shapiro-Wilk test. The chi-square test was used to compare categorical variables according to groups, the t -test was employed to compare continuous data, and percentages and means were utilized to evaluate the subjects’ demographic characteristics. Inter-group examinations of anxiety and fear scores were done using the independent group’s t -test, intra-group examinations were performed via dependent group’s t -test. The level of significance was set at p < 0.05.

2.7

Ethics committee approval

Necessary permissions for the scales used in the research were obtained from the scale owners via e-mail. Ethics committee approval was obtained from the Scientific Research and Publication Ethics Committee of the University (IRB approval no: 2023/61-1). Necessary institutional permissions were obtained from the Provincial Health Directorate where the study was conducted (permission no: E−88488835-433.02-216862634). During the data collection process, the purpose of the study was explained, written and verbal consent of parents and children was obtained. This study was performed in line with the principles of the Declaration of Helsinki. The study was enrolled in the Clinical Trials database (NCT06315816).