# Support Group as a Management Modality for Burning Mouth Syndrome: A Randomized Prospective Study
## 2 Materials and Methods  
A prospective comparative study design was used. The database of a tertiary medical center was searched for adult patients with BMS who visited the oral and maxillofacial department with BMS complaints between January 2014 and December 2019. Of the 365 patients identified, 357 were still alive at the time of recruitment for this study. All were contacted by phone to determine if they were interested in participating in the study. After receiving the details of the procedure, 59 responded positively. From among this group, we selected the patients who met the following inclusion criteria: patients diagnosed with \"primary BMS\" by an oral medicine specialist experienced with the management of BMS, followed for at least 3 months after diagnosis, and who agreed to sign an informed consent form to attend a support group and complete a life-quality questionnaire. All patients also underwent comprehensive anamnesis and clinical and laboratory evaluations prior to the study, as is customary for BMS patients in the department. Patients with a doubtful diagnosis or whose symptoms potentially arose from systemic or local abnormalities were excluded. The final study cohort consisted of 22 patients. The selection process for the study is shown in Figure 1.  
The study protocol was approved by the institutional Helsinki Committee (approval number 0131-19-RMC). The study cohort was randomly divided into two arms by simple randomization method (by flipping a coin). Eleven patients were allocated to take part in support sessions (study group), and the remainder continued with their previous individual BMS management routine (control group). Cognitive therapy and consultation were introduced as valid options in the management of BMS; however, the control group members were not actively assigned for such supportive care as were the members of the study group. Support group sessions were held once weekly for four weeks. Each session lasted 90 min. All meetings were conducted by a social worker ([PERSON]) and an oral medicine specialist ([PERSON]). In the first meeting, patients received information from the oral medicine specialist about the epidemiology, suspected etiologies, management, and treatments for BMS followed by a discussion of the assumed psychological, behavioral and social aspects of the disorder and the basic principles of pain physiology. The group members then introduced themselves and shared their personal experience with BMS. In the second meeting, the oral medicine specialist answered patients' questions about the disorder, and the patients discussed assumed triggers of the oral symptoms. The third meeting was dedicated to a discussion of the different ways in which the members of the group cope with BMS, including physical activity (including yoga, dancing class, Tai Chi, etc. ), mindfulness-based meditation, and medication therapy. The social worker and the oral medicine specialist provided information on possible options of management and pain relief methods from the scientific literature, including cognitive therapy. In the fourth meeting, patients discussed their impressions of the group therapy and how, as a result of their participation, they now related to their symptoms. The intensity of symptoms and the degree to which they disrupted the patients' daily life activities were evaluated with an 11-item self-report life-quality questionnaire based on the validated questionnaire by [PERSON] et al. [27], with some modifications to suit the purpose of the study (see Appendix A). Pain was ranged between 1 and 10: 1-3 = slight pain, 4-7 = moderate pain, and 8-10 = severe pain. Other evaluated parameters were ranged between 1 and 5, as 1-3 considered acceptable and 4-5 considered poor regarding the patient's subjective assessment of life-quality. The questionnaire was completed by both groups before the sessions and again 3 months after their conclusion. Responses were compared between the two time points for each group.