Research design and setting
A quasi-experimental study was conducted in the Hefdah-e-Shahrivar hospital which is a central pediatric hospital in Rasht, Iran. The participants were assigned to two groups, experimental and control.
Participants and sampling
Based on the findings of the study of Shahrabadi et al. [16] and with a confidence interval of 95%, an error of 5%, a test power of 90%, d = 0.9, σ2 = 1.9, and with 10% attrition rate, the sample size was calculated according to the following formula as 30 patients in each group.
$$N\kern0.5em =\kern0.5em {\sigma}^2\frac{{\left({Z}_{1-a/2}\kern0.5em +\kern0.5em {Z}_{1-B}\right)}^2}{d^2}\kern0.5em +\kern0.5em \frac{{\left({Z}_{1-a/2}\right)}^2}{2}=\kern0.5em 1.9\kern0.5em \frac{{\left(1.96\kern0.5em +\kern0.5em 1.28\right)}^2}{0.9^2}\kern0.5em +\kern0.5em \frac{(1.96)^2}{2}=27$$
The participants were the hospitalized children in the age group of 9–12 years who had been admitted to the pediatric hospital due to chronic diseases and were eligible based on the inclusion criteria of the study. The inclusion criteria were: the ability to read and write, hospitalization for the first time, and not taking anti-anxiety drugs. Also, the children with cognitive and learning difficulties did not enter the study.
Sixty eligible children were entered into the study by convenience sampling method. Then, the children were randomly allocated to the intervention or control groups using numbered envelopes. Each envelope included one of two numbers, 1 for the control, or 2 for the intervention group.
Data collection
The data collection was done from June 24, 2019, to December 24, 2020. For data collection, after obtaining the necessary permissions and the code of ethics (IR.GUMS.REC.1398.239), the investigator explained the purpose of conducting the study and, after obtaining the written consent, the demographic data were collected from the parents and the children.
The study tool was a two-section questionnaire. The first section included the demographic characteristics of the participants consisted of the child’s characteristics including age, birth rank, education level, type of disease, place of residence, and the family’s characteristics including the number of family members, history of hospitalization in each member of the family, the parent’s educational level, parent’s job and, their income. These variables were extracted from the literature review [7, 8, 17].
The second section of the study instrument was Spielberger’s State-Trait Anxiety Inventory for children (STAIC). It is a widely used assessment tool as it is easy for children to understand, and is a valid instrument for assessing pediatrics’ anxiety [18]. The pediatrics STAI is a 40-item self-report instrument that is widely used to measure anxiety symptoms in children aged 9–12 years. The first 20 items are related to the “state anxiety” (child’s feelings during responding) and the second 20 items cover the “trait anxiety” (child’s general feelings). All statements start with the stem “I feel” and the respondents have to choose among three responses, the one that best describes their state is scored on a three-point Likert scale from 1 to 3 (e.g., very comfortable, comfortable, or not comfortable). The statements of the trait anxiety scale were scored on a 3-point scale including hardly, sometimes, and never. The anxiety score was calculated based on the mean score, and the higher scores indicated higher anxiety. The score range of the total score of STAIC was from 40 to 120.
The STAIC questionnaire validity and reliability were obtained in the original study. The alpha reliability of the STAIC was 0.87. The concurrent validity of the STAIC was confirmed by its correlation with the two most widely used measures of anxiety in children including the Children’s Manifest Anxiety Scale (CMAS) [19] and the General Anxiety Scale for Children (GASC) [20]. The STAIC Anxiety scale correlated 0.75 with the CMAS and 0.63 with the GASC [21, 22]. Also, the obtained Cronbach’s alpha coefficient in the current study was 0.896.
The intervention in the current study was the education of hospitalized children using the DEP. DEP was a researcher-made educational package including electronic text, images, animations, video, and audio files to introduce the hospital healthcare team (the head nurse, nursing staff, physicians), the time of physicians’ visit, and the nursing interventions. The images were used to show the different parts of the hospital environment (such as the pediatric ward and the rooms, beds, nursing station, and the hospital para-clinical departments). In preparing the DEP, attempts were made to use understandable content for children aged 9–12 years. To design the content, framework, and function of the DEP, we consulted with an expert team that included a child psychologist, hospital nursing manager, pediatric department supervisor, and software engineer. For children in the control group, conventional patients’ education was performed with the usual simple verbal instructions and using an educational booklet. The contents in the booklet were the same as the digital content.
Data analysis
We used SPSS software version 20.0 for the data analysis. Descriptive statistics were used to calculate the means, standard deviations, and the range of scores. According to the Shapiro-Wilk test, the anxiety scores had a normal distribution, therefore, the parametric tests have been used to analyze the scores. To examine the homogeneity of the two groups, a χ2 test or Fisher exact test was used to analyze categorical variables. Differences in the mean scores on the children’s anxiety levels between the two groups were investigated by an independent t-test. A paired t-test was performed to compare the mean scores of the inter-groups. A p-value < 0.05 was considered statistically significant.
Procedure
Fifteen minutes after the admission to the hospital, and before each invasive procedure, the baseline anxiety score of the participated children was recorded based on STAI. Then, the researcher met the participants and their parents in the experimental group in a comfortable private room where they could watch the DEP using a laptop. During the intervention, the children were engaged with the DEP. The intervention was done during a 15 minute session. At the end of the intervention, the children completed the study questionnaire again. For the control group, no intervention was done and they received only the routine admission verbal information at their bedside using the educational pamphlet by the nursing staff. They also completed the questionnaire at similar times to the intervention group. There was no attrition in the experimental and control group (Fig. 1).