A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis

Summary

Background: A typical feature of SSc is the fibrotic involvement of the connectival tissue of the face, which causes microstomia.

Objectives: To test the effectiveness of an educational intervention with "face to face" training, compared to a standard information program, to reduce microstomia in women with SSc.

Methods: SSc patients were randomized to the experimental and control group. Both groups received written and audiovisual information for self-management of microstomia; in addition, the experimental group received a reinforced training at baseline and at follow-up. Primary outcome: change in inter-incisal distance; secondary outcome: patient-reported mouth disability.

Conditions

• Scleroderma, Systemic

Interventions

BEHAVIORAL

Brochure and DVD plus nursing training

After recruitment for both groups of participants, 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. The intervention consisted of stretching exercises and movements involving the mimic muscles to perform in front of a mirror. The control group could learn the standardized exercises for the mouth-opening through information brochure and the audio-visual DVD. 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. For both groups an information brochure and an audio-visual DVD were developed specifically for the study. The audio-visual DVD is available on the IDI-IRCCS institutional website.

BEHAVIORAL

Brochure and DVD only

After recruitment for both groups of participants, 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. The intervention consisted of stretching exercises and movements involving the mimic muscles to perform in front of a mirror. The control group could learn the standardized exercises for the mouth-opening through information brochure and the audio-visual DVD.

Sponsors & Collaborators

• Centro di Eccellenza per la Cultura e la Ricerca Infermieristica (CECRI)

  collaborator UNKNOWN

• Ministry of Health, Italy

  collaborator OTHER_GOV

• IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti

  lead OTHER

Principal Investigators

• Damiano DC Abeni, MD, MPH · IDI-IRCCS, Fondazione Luigi Maria Monti

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-02-01

Primary Completion

2015-01-31

Completion

2015-01-31