Patient Education Before Orthognathic Surgery

Not Applicable

Completed

• Conditions: Malocclusion; Anxiety; Prognathism; Micrognathism
• Interventions: Other: Booklet - Preoperative Educational

• Registration Number: NCT01803204
• Lead Sponsor: University of Sao Paulo

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

Detailed Description

It is a clinical randomized controlled trial being developed from February 2013 to September 2015, divided into two phases: a pilot study without randomization for impact testing and evaluation of intervention and, in the second time, the clinical randomized study with possible changes after the pilot study.

Will be entered in the study patients undergoing maxillofacial surgery originating at outpatient clinic located in the municipality of São Paulo. The study aims to evaluate the effects of educational material in postoperative education orthognathic surgery, with intervals between pre and postoperative serials.

Recruitment plan of patients: the patients seen in oral and maxillofacial surgery and traumatology clinic located in the municipality of São Paulo with indication for orthognathic surgery will be covered by personally and invited to participate in intervention research. To control the bias will be included in the study patients of the same surgical team, to ensure the same surgical technique and postoperative guidance conduct by the surgeon.

Study variables: it is intended to analyse the socio-demographic variables: sex, age, level of education; independent variables: surgical technique, recovery time, difficulties experienced during the postoperative period, possible surgical complications; dependent variables: signs and symptoms postoperatively (presence or absence) and monitoring of care during the postoperative period; level of knowledge about the post-op of orthognathic surgery and anxiety levels (State-trait anxiety inventory-IDATE).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-04
• Primary Completion: 2014-12
• Study Completion: 2015-09
• Results First Submitted: 2016-01-17
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-21
• Last Update Submitted: 2018-08-21
• Results First Posted: 2019-01-31
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Booklet - Preoperative Educational	Booklet - Preoperative Educational	This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase

Primary Outcome Measures

Name	Time	Method
Number of Patients With Clinical Changes During the Postoperative Recovery	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)	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.

Secondary Outcome Measures

Name	Time	Method
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	The patient's knowledge about the surgery will be assessed by a test developed by the researcher (A test with 10 multiple choice questions, each questions with 4 alternatives, about care after surgery. Each questions value 1 point, for better results was considered higher 7 points and for worse results was considered low 5 points. A total value for the Knowledge test was 10 points (rage 0-10) The acceptable score to understand that the patient is aware of the surgery was 7.; This was applied on two occasions: first contact with the patient before surgery, signed a consent form before the start researcher educational intervention (during the preoperative phase).; The second test will be given at the first follow-up visit with the surgeon (seventh postoperative day)

Trial Locations

Locations (1)

Cristina Silva Sousa; 🇧🇷 Sao Paulo, Brazil