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Patient Education Before Orthognathic Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University of Sao Paulo.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Cristina Silva Sousa, University of Sao Paulo Identifier:
First received: February 25, 2013
Last updated: December 4, 2014
Last verified: December 2014
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

Condition Intervention
Other: Booklet - Preoperative Educational

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Evaluation of an Educational Booklet for Perioperative Orthognathic Surgery: Randomized Clinical Trial.

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Number of patients with clinical changes during the postoperative recovery [ Time Frame: The care of oral hygiene, nutrition, mobility and sensitivity, appearance of lips, swelling, pain and sleep 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. 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:
  • Number of patients with better knowledge about the surgery [ Time Frame: A test with multiple choice questions about care after 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 (multiple choice questions about care after surgery) 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)

Other Outcome Measures:
  • Reducing levels of anxiety after educational intervention [ Time Frame: The inventory of state-trait anxiety will be applied in the first contact with the patient before surgery and on the seventh day after surgery ]
    The levels of anxiety during the perioperative period will be measured with the inventory of state-trait anxiety. The existing scale will be 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)

Estimated Enrollment: 48
Study Start Date: February 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Booklet - Preoperative Educational
This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase
Other: Booklet - Preoperative Educational
the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.
No Intervention: Control
This group don't received booklet, they will be monitored during the postoperative period to control

Detailed Description:

It is a clinical randomized controlled trial being developed from February 2013 to December 2014, 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).


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Exclusion Criteria:

  • patients undergoing reoperation of orthognathic surgery;
  • with cleft lip-palate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01803204

Cristina Silva Sousa
Sao Paulo, Brazil, 04116020
Sponsors and Collaborators
University of Sao Paulo
Principal Investigator: Cristina S Sousa, MsC University of Sao Paulo
  More Information

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

Responsible Party: Cristina Silva Sousa, Student PhD, University of Sao Paulo Identifier: NCT01803204     History of Changes
Other Study ID Numbers: 193.454 
Study First Received: February 25, 2013
Last Updated: December 4, 2014

Keywords provided by University of Sao Paulo:
Orthognathic surgery
Patient educational as topic
Patient educational handout

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Mandibular Diseases processed this record on February 17, 2017