Patient Education Before Orthognathic Surgery
|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
|Condition or disease||Intervention/treatment||Phase|
|Malocclusion Anxiety Micrognathism Prognathism||Other: Booklet - Preoperative Educational||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Evaluation of an Educational Booklet for Perioperative Orthognathic Surgery: Randomized Clinical Trial.|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||July 2015|
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
- 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.
- 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)
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803204
|Contact: Cristina S Sousa, MsC||+ 55 11 firstname.lastname@example.org|
|Cristina Silva Sousa||Recruiting|
|Sao Paulo, Brazil, 04116020|
|Contact: Cristina S Sousa, MsC + 55 11 996017972 email@example.com|
|Principal Investigator: Cristina S Sousa, MsC|
|Sub-Investigator: Ruth Natalia T Turrini, PhD|
|Principal Investigator:||Cristina S Sousa, MsC||University of Sao Paulo|