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

Claudia Uras, Simona Mastroeni, Stefano Tabolli, Cinzia Masini, Sabatino Pallotta, Patrizia Teofoli, Gennaro Rocco, Cinzia Mazzanti, Damiano Abeni

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)1747-1756
Number of pages10
JournalClinical Rehabilitation
Volume33
Issue number11
DOIs
Publication statusPublished - Nov 1 2019

Keywords

  • nursing training
  • patient self-management
  • randomized controlled trial
  • rehabilitation microstomia
  • Systemic sclerosis

ASJC Scopus subject areas

  • Physical Therapy, Sports Therapy and Rehabilitation
  • Rehabilitation

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