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

NCT03766243 | Completed DMC

• 1 other identifier: SScMicrostomia398-1
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Microstomia; Rehabilitation; Self-Management

Outcome Measures

Primary Outcomes (1)

• Interincisal distance

  Change in the maximum distance between the tip of the upper and lower incisors, from baseline to 1-year follow-up.

  1 year

Secondary Outcomes (4)

• Self-reported severity of mouth disability

  1 year

• Dermatological life quality

  1 year

• Disease-specific life quality

  1 year

• Psychological well-being

  1 year

Study Arms (2)

Brochure and DVD plus nursing training

EXPERIMENTAL

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.

Behavioral: Brochure and DVD plus nursing training

Brochure and DVD only

ACTIVE COMPARATOR

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.

Behavioral: Brochure and DVD only

Interventions

Brochure and DVD plus nursing training BEHAVIORAL

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.

Brochure and DVD plus nursing training

Brochure and DVD only BEHAVIORAL

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.

Brochure and DVD only

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti: lead
• Centro di Eccellenza per la Cultura e la Ricerca Infermieristica (CECRI): collaborator
• Ministry of Health, Italy: collaborator

Related Publications (7)

• Naylor WP, Douglass CW, Mix E. The nonsurgical treatment of microstomia in scleroderma: a pilot study. Oral Surg Oral Med Oral Pathol. 1984 May;57(5):508-11. doi: 10.1016/0030-4220(84)90309-8.

  PMID: 6587299 BACKGROUND

• Ayala F, de Baranda Andujar PS. Effect of 3 different active stretch durations on hip flexion range of motion. J Strength Cond Res. 2010 Feb;24(2):430-6. doi: 10.1519/JSC.0b013e3181c0674f.

  PMID: 20072058 BACKGROUND

• Maddali Bongi S, Del Rosso A, Miniati I, Galluccio F, Landi G, Tai G, Matucci-Cerinic M. The Italian version of the Mouth Handicap in Systemic Sclerosis scale (MHISS) is valid, reliable and useful in assessing oral health-related quality of life (OHRQoL) in systemic sclerosis (SSc) patients. Rheumatol Int. 2012 Sep;32(9):2785-90. doi: 10.1007/s00296-011-2049-x. Epub 2011 Aug 17.

  PMID: 21847653 BACKGROUND

• Uras C, Giannantoni P, Tabolli S, DI Giulio P, Peghetti A, Cianchini G, Abeni D. Measuring disability of women with systemic sclerosis: validation of the italian version of the systemic sclerosis questionnaire. G Ital Dermatol Venereol. 2016 Aug;151(4):332-9. Epub 2015 May 13.

  PMID: 25969348 BACKGROUND

• Synnot A, Ryan R, Prictor M, Fetherstonhaugh D, Parker B. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database Syst Rev. 2014 May 9;2014(5):CD003717. doi: 10.1002/14651858.CD003717.pub3.

  PMID: 24809816 BACKGROUND

• Kroon FP, van der Burg LR, Buchbinder R, Osborne RH, Johnston RV, Pitt V. Self-management education programmes for osteoarthritis. Cochrane Database Syst Rev. 2014 Jan 15;2014(1):CD008963. doi: 10.1002/14651858.CD008963.pub2.

  PMID: 24425500 BACKGROUND

• Lorig K. Partnerships between expert patients and physicians. Lancet. 2002 Mar 9;359(9309):814-5. doi: 10.1016/S0140-6736(02)07959-X. No abstract available.

  PMID: 11897275 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Systemic; Microstomia

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Damiano DC Abeni, MD, MPH

  IDI-IRCCS, Fondazione Luigi Maria Monti

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: December 6, 2018
• Study Start: February 1, 2013
• Primary Completion: January 31, 2015
• Study Completion: January 31, 2015
• Last Updated: December 6, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share