Patient Education Before Orthognathic Surgery
Primary Purpose
Malocclusion, Anxiety, Micrognathism
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Booklet - Preoperative Educational
Sponsored by
About this trial
This is an interventional health services research trial for Malocclusion focused on measuring Anxiety, Orthognathic surgery, Patient educational as topic, Patient educational handout, Pamphlets
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.
Sites / Locations
- Cristina Silva Sousa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Booklet - Preoperative Educational
Control
Arm Description
This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase
This group don't received booklet, they will be monitored during the postoperative period to control
Outcomes
Primary Outcome Measures
Number of Patients With Clinical Changes During the Postoperative Recovery
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 Outcome Measures
Average Test Arrangements on 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)
Full Information
NCT ID
NCT01803204
First Posted
February 25, 2013
Last Updated
August 21, 2018
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01803204
Brief Title
Patient Education Before Orthognathic Surgery
Official Title
Evaluation of an Educational Booklet for Perioperative Orthognathic Surgery: Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Anxiety, Micrognathism, Prognathism
Keywords
Anxiety, Orthognathic surgery, Patient educational as topic, Patient educational handout, Pamphlets
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Booklet - Preoperative Educational
Arm Type
Experimental
Arm Description
This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group don't received booklet, they will be monitored during the postoperative period to control
Intervention Type
Other
Intervention Name(s)
Booklet - Preoperative Educational
Intervention Description
the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.
Primary Outcome Measure Information:
Title
Number of Patients With Clinical Changes During the Postoperative Recovery
Description
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.
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)
Secondary Outcome Measure Information:
Title
Average Test Arrangements on Surgery
Description
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)
Time Frame
This will be delivered in the first contact with the patient before surgery and on the seventh day after surgery
Other Pre-specified Outcome Measures:
Title
Levels of Anxiety After Educational Intervention
Description
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
Time Frame
The STAI will be applied on the seventh day after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina S Sousa, MsC
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cristina Silva Sousa
City
Sao Paulo
ZIP/Postal Code
04116020
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23250262
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
25031119
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.
Results Reference
background
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.
Results Reference
background
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Patient Education Before Orthognathic Surgery
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