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Completed

NCT Number: NCT01803204

Patient Education Before Orthognathic Surgery

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

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Key information

Conditions

Malocclusion Anxiety Anxiety Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Mandibular Diseases Maxillofacial Abnormalities Mental Disorders Micrognathism Musculoskeletal Abnormalities Musculoskeletal Diseases Prognathism Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cristina Silva Sousa

São Paulo, 04116020, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Booklet - Preoperative Educational

Other

the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.

Primary outcomes

  1. Number of Patients With Clinical Changes During the Postoperative Recovery

    Time frame: 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)

    A review of the patient's recovery after surgery will occur during follow-up visits with the surgeon, It was rated the care of oral hygiene, nutrition, mobility and sensitivity, appearance of lips, swelling, pain and sleep . The patient will be accompanied by the researcher during the return and the data will be evaluated and investigated as annotated patient outcomes.

Secondary outcomes

  1. Average Test Arrangements on Surgery

    Time frame: 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 (A test with 10 multiple choice questions, each questions with 4 alternatives, about care after surgery. Each questions value 1 point, for better results was considered higher 7 points and for worse results was considered low 5 points. A total value for the Knowledge test was 10 points (rage 0-10) The acceptable score to understand that the patient is aware of the surgery was 7.

    This was 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)

Other outcomes

  1. Levels of Anxiety After Educational Intervention

    Time frame: The STAI will be applied on the seventh day after surgery

    The levels of anxiety during the perioperative period will be measured with the State-Trait Anxiety Inventory (STAI).

    The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety sub-scales Responses for the S-Anxiety scale assess intensity of current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the T-Anxiety scale assess fre- quency of feelings "in general": 1) almost never, 2) some- times, 3) often, and 4) almost always.

    Scoring. Item scores are added to obtain subtest total scores. Scoring should be reversed for anxiety-absent items (19 items of the total 40).

    Score interpretation. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale For results this intervention was considered S-STAI Anxiety with lower scores (< 39) after the intervention

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Evaluation of an Educational Booklet for Perioperative Orthognathic Surgery: Randomized Clinical Trial.

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Mar 4, 2013
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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