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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 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Booklet - Preoperative Educational | Experimental | This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase |
|
| Control | No Intervention | This group don't received booklet, they will be monitored during the postoperative period to control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Booklet - Preoperative Educational | Other | the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of Anxiety After Educational Intervention | 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 |
Inclusion Criteria:
Patients undergoing orthognathic surgery during the study and with surgical technique:
Informed consent
Patients in the maxillofacial outpatient clinic located at Sao Paulo
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristina S Sousa, MsC | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cristina Silva Sousa | São Paulo | 04116020 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23250262 | Background | 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. | |
| Background | 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. | ||
| 25031119 |
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For the pilot study and testing of the evaluation printed were contacted 8 patients as intervention group and control group not applied.
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| ID | Title | Description |
|---|---|---|
| FG000 | Booklet - Preoperative Educational | This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase Booklet - Preoperative Educational: the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery. |
| FG001 | Control | This group don't received booklet, they will be monitored during the postoperative period to control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Booklet - Preoperative Educational | This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase Booklet - Preoperative Educational: the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 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) |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Booklet - Preoperative Educational | This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase Booklet - Preoperative Educational: the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery. |
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It's possible lack of patient adherence to educational intervention, which would lead to lower intervention response rates and the possible use of other technologies during the process.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Sousa | USP | +5511996017972 | crissousa@usp.br |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D001008 | Anxiety Disorders |
| D008844 | Micrognathism |
| D011378 | Prognathism |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D001523 | Mental Disorders |
| D007569 | Jaw Abnormalities |
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| This will be delivered in the first contact with the patient before surgery and on the seventh day after surgery |
| The STAI will be applied on the seventh day after surgery |
| Background |
| 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. |
| Background | Sousa CS, Turrini RNT. Complications in orthognathic surgery: A comprehensive review. Journal of Oral and Maxillofacial Surgery, Medicine, and Pathology. 2012;24:67-74. |
| Control |
This group don't received booklet, they will be monitored during the postoperative period to control |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | This group don't received booklet, they will be monitored during the postoperative period to control |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | This will be delivered in the first contact with the patient before surgery and on the seventh day after surgery |
|
|
|
|
| Other Pre-specified | Levels of Anxiety After Educational Intervention | 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 | Posted | Mean | Standard Deviation | score on a scale | The STAI will be applied on the seventh day after surgery |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Control | This group don't received booklet, they will be monitored during the postoperative period to control | 0 | 20 | 0 | 20 |
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| D007571 |
| Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008336 | Mandibular Diseases |
| Pos-op Fourth visit |
|
| Pre-operatively |
|
| Pos-op Third visit S-STAI anxiety |
|
| Pos-op Fourth visit S-STAI anxiety |
|