A comparison between two educational methods in the rehabilitation of the microstomia in systemic sclerosis: a randomized controlled trial
Autori
Objective
To test the effectiveness of an educational intervention including "face to face" training, compared to a standard information program, to reduce microstomia in women with systemic sclerosis.
Design
Single-blind, two-arm, randomized controlled study with a 12-month follow-up period.
Setting
Hospital wards of a large Italian dermatological reference center.
Subjects
Female inpatients with diagnosis of systemic sclerosis.
Interventions
For both groups an information brochure and an audio-visual DVD were developed specifically for the study. The control group was assigned to educational materials alone (i.e. brochures and DVD), while the experimental group, in addition to the same educational materials, received specific "face-to-face" interventions, repeated at each follow-up visit.
Main measures
Primary outcome was measurement of the opening of the mouth. Secondary outcomes was the self-reported mouth disability.
Results
The intention-to-treat analysis included 63 patients. Compared to the baseline measurement, we observed an increase of the mouth opening of 0.31 cm (95% confidence interval: 0.13-0.49), P = 0.003; in the control group, the increase was 0.13 cm (95% confidence interval: 0.01-0.25), P = 0.06. The difference in improvement between the two groups was not statistically significant (P = 0.10); however, it reached statistical significance in the per-protocol analysis (39 patients, P = 0.02).
Conclusion
Face-to-face nursing rehabilitation training seems to improve microstomia to a greater extent, when compared to a standard intervention based only on written and audio-visual materials
Keywords
Systemic sclerosis; nursing training; patient self-management; randomized controlled trial; rehabilitation microstomia.