Material and Methods
Anxiety, anxiety, anhedonia, depression, subjects3, hyperactivity, P., OPMD, depressive, agitation, Post-biopsy, cognitive deficits, cognitive and motivational psychomotor, Depression, irritability
DISORDER, MAY, CAVITY
- Study designThis open-label randomized clinical trial (RCT) was approved by the local Institutional Ethics Committee of the P. Giaccone University Hospital of Palermo, Italy (approval #1/2022). The study was conducted according to the principles of the Declaration of Helsinki regarding experimentation involving human subjects, and written informed consent was obtained from all participants.The authors consecutively included all patients with a clinical suspicion of an oral potentially malignant disorder (OPMD), who had been referred to the Oral Medicine Unit at the P. Giaccone University Hospital in Palermo (Italy), from May to November 2022. Prior to the oral incisional biopsy, 50 patients were randomly allocated (i.e., computer-generated) to the test or control group; a graphic novel was provided to 25 patients in the test group.- Eligibility criteria1. age of patients ≥ 18 years2. absence of suspected or obvious pregnancy status in female subjects3. patients affected by OPMD4. agree to participate in the RCT, and the ability to read and understand informed consent5. patients not affected by any known psychological disorder.- Exclusion criteria1. patients with cognitive deficits, such that they cannot adequately complete the questionnaire and the visually impaired2. patients who are to undergo surgical treatment and/or biopsy, for reasons other than OPMD (e.g., salivary gland biopsy)3. patients using benzodiazepines or other psychotropic medications.- Oral graphic novel descriptionThe authors used a comic strip consisting of a sequence of 9 colourful vignettes, in which the procedure of an oral biopsy was described to the patient. (Fig. 1. A patient in the mirror is inspecting their oral cavity and they find something abnormal2. The patient seeks the clinical opinion of a physician3. The patient is examined by their dentist4. Thereafter, during the night, the patient ruminates as to what this abnormality might be5. Having been referred for diagnostic procedures, the patient is in the waiting room of the Oral Medicine Unit6. The Oral Medicine team greets the patient, and performs an OPMD biopsy7. Post-biopsy, the patient is leaving the Oral Medicine Unit while applying an ice pack after surgery8. The patient is requested (via a phone call) to return for the histology results9. An oral physician informs the patient of the histological findings.
The English version of the graphic novel, offered to the test group (with thanks to G. Piazza).- Description of tests used to assess anxietyAll the 50 recruited patients received the Beck Depression Inventory (BDI) and the Depression Anxiety Stress Scales-21 (DASS-21). Prior to the surgical procedures (i.e., oral biopsy), these questionnaires were administered anonymously in a mixed paper-pencil and QR Code mode. The administering psychologist (M.B.) was present for questions and clarification. Before filling out the BDI and DASS-21 questionnaires, patients were asked to answer some questions regarding their demographic data and medical history (e.g., smoking habits). The BDI is a self-administered instrument for assessing the severity of the affective, cognitive and motivational psychomotor, and the vegetative components of depression. It comprises 21 sets of statements, describing various and increasing levels of depressive symptomatology; each statement corresponds to a score, and these scores are totalled to produce a total score. Higher scores of BDI are correlated with major depressive state (The present study also used the psychometric properties of the Italian version of the DASS-21 to explore its use in an Italian context. The DASS-21 facilitates the identification of three constructs: depression, anxiety, and stress. Depression includes: dysphoria, hopelessness, devaluation of life, lack of interest/involvement in regulating daily life, anhedonia, and inertia. Anxiety relates to: autonomic nervous system arousal, skeletal muscle effects, situational anxiety, and the subjective experience of anxious effects. Stress relates to: the presence of chronic non-specific arousal levels, relaxation difficulties, nervous arousal, irritability, agitation, hyperactivity, and impatience (A digital platform, including the following, was created:1. a section with two separate BDI, DASS-21 tests/forms for patients, who completed them anonymously. And, in order to enhance the information collating process, a QR code was created for each test/form in such a way that patients could easily scan these with their cell phone camera and quickly complete each test/form2. an administrative section, including a Dashboard (providing an overview of the tests/forms, to be completed daily) and several subsections permitting the extrapolation of statistical data, each form being based on the answers provided by the patients. The React framework (for the front-end) and Php and MySql (for the back-end) was used to create the web platform.- Outcome MeasuresThe following data were recorded for each patient: demographic data, smoking habit, drug intake, the BDI scores according to the An Inventory for Measuring Depression (- Statistical AnalysisThe analysis was performed using the software R (R Core Team, 2022). Descriptive statistics were used to analyse the patients’ socio-demographic and physical characteristics. BDI and DASS-21 scores were summarized through mean value, standard deviation (SD), maximum, median and interquartile range (IQR). In order to analyse any significant statistical difference of anxiety between the test and control groups, the data were initially tested to ascertain if any socio-demographic or physical characteristics were associated with group membership by Chi-Square Test. The Mann-Whitney U test was used to evaluate the significant differences between treatment groups, with respect to BDI and DASS-21 scores. In order to quantify any statistically significant difference, the difference between BDI and DASS-21 scores in the groups was evaluated by the Hodges-Lehmann estimator. Any relation between BDI and DASS-21 scores was measured through a linear correlation coefficient.