A comparison between two educational methods in the rehabilitation of the microstomia in systemic sclerosis: a randomized controlled trial

Abstract

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.

EULAR recommendations for the non-pharmacological management of systemic lupus erythematosus and systemic sclerosis

“…RCTs assessed as intermediate in RoB assessment employed patient education as a part of physical exercise programmes. The addition of patient education was efficacious in improving aerobic capacity in an RCT of SLE50 (LoE: 2) and mouth opening as compared with the same physical exercise programme (mouth stretching) in an RCT of SSc51 (LoE: 2). Qualitative assessments of multidisciplinary patient education programmes52 (LoE: 4) and group education on disease management53 (LoE: 4) found these strategies to be beneficial for patients with SLE in terms of improving HRQoL52 (LoE: 4) as well as for implementing favourable lifestyle changes53 (LoE: 4); these studies were assessed as robust.…”

The effect of a home-based orofacial exercise program on oral aperture of patients with systemic sclerosis: A single-blind prospective randomized controlled trial

“…Also, in the study of Yuen et al,[ 16 ] the adherence rate was low, which may be one of the major factors that would have impacted their results. In the study of Uras et al,[ 26 ] 12 months of orofacial exercise program was given to both experimental and control groups. However, the experimental group has received the program under the supervision of a trained nurse, whereas the control group had only brochures and digital videodisc explaining the program.…”

Self‐management interventions in systemic sclerosis: A systematic review

“…The studies included in this systematic review had predominately small samples, contributing to their poor methodological quality due to inadequate power and external validity. For example, only four studies were adequately powered (Khanna et al, 2019; Rannou et al, 2017; Schouffoer et al, 2011; Uras et al, 2019), and only three studies calculated effect sizes for the outcomes after intervention delivery (Kwakkenbos et al, 2011; Landim et al, 2019; Poole et al, 2014).…”