NCT01803204

Patient Education Before Orthognathic Surgery

Evaluation of an Educational Booklet for Perioperative Orthognathic Surgery: Randomized Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Malocclusion
• Anxiety
• Micrognathism
• Prognathism

Interventions

Type	Name	Description
OTHER	Booklet - Preoperative Educational	the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-12-01
• Completion: 2015-09-01
• First posted: 2013-03-04
• Last updated: 2019-01-31
• Results posted: 2019-01-31

Locations

1 site across 1 country: Brazil