Patient Education Before Orthognathic Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Cristina Silva Sousa, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01803204
First received: February 25, 2013
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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
Malocclusion
Anxiety
Micrognathism
Prognathism
Other: Booklet - Preoperative Educational

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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: February 2015
Estimated Primary Completion Date: December 2013 (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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01803204

Contacts
Contact: Cristina S Sousa, MsC + 55 11 996017972 crissousa@usp.br

Locations
Brazil
Cristina Silva Sousa Recruiting
Sao Paulo, Brazil, 04116020
Contact: Cristina S Sousa, MsC    + 55 11 996017972    crissousa@usp.br   
Principal Investigator: Cristina S Sousa, MsC         
Sub-Investigator: Ruth Natalia T Turrini, PhD         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Cristina S Sousa, MsC University of Sao Paulo
  More Information

Publications:
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
ClinicalTrials.gov Identifier: NCT01803204     History of Changes
Other Study ID Numbers: 193.454
Study First Received: February 25, 2013
Last Updated: February 28, 2013
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Tooth Diseases
Anxiety Disorders
Malocclusion
Micrognathism
Prognathism
Mental Disorders
Stomatognathic Diseases
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Mandibular Diseases

ClinicalTrials.gov processed this record on July 24, 2014