Patient Education Before Orthognathic Surgery

NCT01803204 | Completed Results DMC

• 1 other identifier: 193.454
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effectiveness in the use of an educational material through: Assessment of knowledge about post-operative orthognathic surgery; assessing levels of anxiety with the survey of Anxiety Inventory-STATE-TRAIT; clinical evaluation of self-care in the management of postoperative signs and symptoms

Conditions

Malocclusion; Anxiety; Micrognathism; Prognathism

Keywords

Anxiety; Orthognathic surgery; Patient educational as topic; Patient educational handout; Pamphlets

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Clinical Changes During the Postoperative Recovery

  A review of the patient's recovery after surgery will occur during follow-up visits with the surgeon, It was rated the care of oral hygiene, nutrition, mobility and sensitivity, appearance of lips, swelling, pain and sleep . The patient will be accompanied by the researcher during the return and the data will be evaluated and investigated as annotated patient outcomes.

  this measure will be assessed weekly in the first forty days postoperatively (seventh day, fourteenth day, twenty-first day and fortieth day after the surgery)

Secondary Outcomes (1)

• Average Test Arrangements on Surgery

  This will be delivered in the first contact with the patient before surgery and on the seventh day after surgery

Other Outcomes (1)

• Levels of Anxiety After Educational Intervention

  The STAI will be applied on the seventh day after surgery

Study Arms (2)

Booklet - Preoperative Educational

EXPERIMENTAL

This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase

Other: Booklet - Preoperative Educational

Control

NO INTERVENTION

This group don't received booklet, they will be monitored during the postoperative period to control

Interventions

Booklet - Preoperative Educational OTHER

the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.

Booklet - Preoperative Educational

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing orthognathic surgery during the study and with surgical technique:
• sagittal maxillary bilateral osteotomy;
• maxillary;
• vertical osteotomy;
• Lefort I osteotomy combined with or without mentoplastia and maxillary disjunction.
• Informed consent
• Patients in the maxillofacial outpatient clinic located at Sao Paulo

You may not qualify if:

• patients undergoing reoperation of orthognathic surgery;
• with cleft lip-palate.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Cristina Silva Sousa

São Paulo, 04116020, Brazil

Location

Related Publications (4)

• dos Santos MR, Sousa CS, Turrini RN. [Perception of orthognathic surgery patients on postoperative care]. Rev Esc Enferm USP. 2012 Oct;46 Spec No:78-85. doi: 10.1590/s0080-62342012000700012. Portuguese.

  PMID: 23250262 BACKGROUND

• Sousa CS, Turrini RNT. Validação de constructo de tecnologia educativa para pacientes mediante aplicação da técnica Delphi. Acta Paulista de Enfermagem. 2012;25(6):990-6.

  BACKGROUND

• Sousa CS, Turrini RN. Creating and validating educational material for patients undergoing orthognathic surgery. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Dec;6(4):166-72. doi: 10.1016/j.anr.2012.10.006. Epub 2012 Nov 7.

  PMID: 25031119 BACKGROUND

• Sousa CS, Turrini RNT. Complications in orthognathic surgery: A comprehensive review. Journal of Oral and Maxillofacial Surgery, Medicine, and Pathology. 2012;24:67-74.

  BACKGROUND

MeSH Terms

Conditions

Malocclusion; Anxiety Disorders; Micrognathism; Prognathism

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Mental Disorders; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mandibular Diseases

Limitations and Caveats

It's possible lack of patient adherence to educational intervention, which would lead to lower intervention response rates and the possible use of other technologies during the process.

Results Point of Contact

• Title: Cristina Sousa
• Organization: USP

crissousa@usp.br

+5511996017972

Study Officials

• Cristina S Sousa, MsC

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student PhD

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: March 4, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: September 1, 2015
• Last Updated: January 31, 2019
• Results First Posted: January 31, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)