A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis (SScM398-1)
Scleroderma, Systemic
About this trial
This is an interventional supportive care trial for Scleroderma, Systemic focused on measuring Microstomia, Rehabilitation, Self-Management
Eligibility Criteria
Inclusion Criteria:
- diagnosis of SSc, according to the ACR/EULAR criteria;
- age >18 years;
- ability to understand the Italian language;
- subjective perception of problems with opening the mouth, such as hardened tissues, reduced mobility, pain - confirmed by a dermatologist;
- signed informed consent.
Exclusion Criteria:
- edentulous patients,
- presence of dental conditions,
- documented dysfunction of the temporo-mandibular joint,
- oral neoplasia,
- sub-mandibular inflammatory conditions,
- patients already undergoing face massages or face physiotherapy,
- patients who had undergone mouth lipofilling,
- patients with severe hand disability (including deep ulcers, and severe pain),
- patients with documented psychiatric conditions or taking psychotropic medications.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Brochure and DVD plus nursing training
Brochure and DVD only
In addition to the "control intervention", see below, the experimental group was closely followed by the research nurse, an expert in Adult Education, who held 20-minute "face to face" meetings at baseline and at follow-up with the patients allocated to the experimental group. The nurse provided theoretical explanations on the exercises, watched the explanatory DVD with the patients, answering questions and commenting relevant points, and then had the patients repeat the exercises in front of a mirror under direct observation, so that any errors could be pointed out and corrected.
After recruitment, in a 30-minute meeting, a clinical nurse measured the opening of the mouth. She gave each participant the information brochure, the audio-visual DVD for self-management of oral exercises, diary card, and the research questionnaires, and explained their content and use. At the same time, she contacted the research nurse to obtain the random allocation to one of the study groups for that patient. These exercises had to be done every day for the entire duration of the program (12 months) and registered in the diary with any comments.