Clinical trial NCT01803204: Patient Education Before Orthognathic Surgery
Official title: Evaluation of an Educational Booklet for Perioperative Orthognathic Surgery: Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Anxiety
Micrognathism
Prognathism
Keywords: Anxiety
Orthognathic surgery
Patient educational as topic
Patient educational handout
Pamphlets
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-03-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

Eligibility 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.

Primary outcomes:
measure: Number of Patients With Clinical Changes During the Postoperative Recovery
timeFrame: this measure will be assessed weekly in the first forty days postoperatively (seventh day, fourteenth day, twenty-first day and fortieth day after the surgery)
Secondary outcomes:
measure: Average Test Arrangements on Surgery
timeFrame: This will be delivered in the first contact with the patient before surgery and on the seventh day after surgery
Other outcomes:
measure: Levels of Anxiety After Educational Intervention
timeFrame: The STAI will be applied on the seventh day after surgery
Locations:
city: Sao Paulo
country: Brazil
facility: Cristina Silva Sousa
Study officials:
affiliation: University of Sao Paulo
name: Cristina S Sousa, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: dos Santos MR, Sousa CS, Turrini RN. [Perception of orthognathic surgery patients on postoperative care]. Rev Esc Enferm USP. 2012 Oct;46 Spec No:78-85. doi: 10.1590/s0080-62342012000700012. Portuguese.
citation: 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.
citation: Sousa CS, Turrini RN. Creating and validating educational material for patients undergoing orthognathic surgery. Asian Nurs Res (Korean Soc Nurs Sci). 2012 Dec;6(4):166-72. doi: 10.1016/j.anr.2012.10.006. Epub 2012 Nov 7.
citation: Sousa CS, Turrini RNT. Complications in orthognathic surgery: A comprehensive review. Journal of Oral and Maxillofacial Surgery, Medicine, and Pathology. 2012;24:67-74.