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Patient Education Before Orthognathic Surgery

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ClinicalTrials.gov Identifier: NCT01803204
Recruitment Status : Unknown
Verified December 2014 by Cristina Silva Sousa, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : March 4, 2013
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
Cristina Silva Sousa, University of Sao Paulo

February 25, 2013
March 4, 2013
December 5, 2014
February 2013
December 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01803204 on ClinicalTrials.gov Archive Site
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)
Same as current
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)
Same as current
 
Patient Education Before Orthognathic Surgery
Evaluation of an Educational Booklet for Perioperative Orthognathic Surgery: Randomized Clinical Trial.
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

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).

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
  • Malocclusion
  • Anxiety
  • Micrognathism
  • Prognathism
Other: Booklet - Preoperative Educational
the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.
  • Experimental: Booklet - Preoperative Educational
    This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase
    Intervention: Other: Booklet - Preoperative Educational
  • No Intervention: Control
    This group don't received booklet, they will be monitored during the postoperative period to control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
48
Same as current
July 2015
December 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01803204
193.454
Yes
Not Provided
Not Provided
Cristina Silva Sousa, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Cristina S Sousa, MsC University of Sao Paulo
University of Sao Paulo
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP