Anxiety, Malocclusion, Micrognathism, Prognathism
Conditions
Keywords
Anxiety, Orthognathic surgery, Patient educational as topic, Patient educational handout, Pamphlets
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).
Interventions
OTHERBooklet - Preoperative Educational
the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Clinical Changes During the Postoperative Recovery | 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
| Measure | Time frame | Description |
|---|---|---|
| Average Test Arrangements on 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 (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
| Measure | Time frame | Description |
|---|---|---|
| Levels of Anxiety After Educational Intervention | 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 |
Countries
Brazil
Participant flow
Recruitment details
For the pilot study and testing of the evaluation printed were contacted 8 patients as intervention group and control group not applied.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Control This group don't received booklet, they will be monitored during the postoperative period to control | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Control | Booklet - Preoperative Educational | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 18 Participants | 35 Participants |
| Age, Continuous | 27.4 years STANDARD_DEVIATION 6.9 | 26.8 years STANDARD_DEVIATION 8.2 | 27.1 years STANDARD_DEVIATION 7.5 |
| Region of Enrollment Brazil | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Booklet - Preoperative Educational | Number of Patients With Clinical Changes During the Postoperative Recovery | 10 participants |
| Control | Number of Patients With Clinical Changes During the Postoperative Recovery | 10 participants |
p-value: 1GEE
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)
Time frame: This will be delivered in the first contact with the patient before surgery and on the seventh day after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Booklet - Preoperative Educational | Average Test Arrangements on Surgery | Pos-op First visit | 6.5 score on a scale | Standard Deviation 1.53 |
| Booklet - Preoperative Educational | Average Test Arrangements on Surgery | Pos -op Thrid visit | 6.8 score on a scale | Standard Deviation 1.64 |
| Booklet - Preoperative Educational | Average Test Arrangements on Surgery | Pos-op Fourth visit | 7.00 score on a scale | Standard Deviation 1.55 |
| Booklet - Preoperative Educational | Average Test Arrangements on Surgery | Pre-operatively | 4.20 score on a scale | Standard Deviation 1.72 |
| Control | Average Test Arrangements on Surgery | Pre-operatively | 4.30 score on a scale | Standard Deviation 2.22 |
| Control | Average Test Arrangements on Surgery | Pos-op First visit | 4.3 score on a scale | Standard Deviation 1.94 |
| Control | Average Test Arrangements on Surgery | Pos-op Fourth visit | 5.20 score on a scale | Standard Deviation 2.32 |
| Control | Average Test Arrangements on Surgery | Pos -op Thrid visit | 5.0 score on a scale | Standard Deviation 2.21 |
p-value: <0.01Mist Effects Model
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
Time frame: The STAI will be applied on the seventh day after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Booklet - Preoperative Educational | Levels of Anxiety After Educational Intervention | Pre-operatively S-STAI anxiety | 39.30 score on a scale | Standard Deviation 12.13 |
| Booklet - Preoperative Educational | Levels of Anxiety After Educational Intervention | Pos -op First visit S-STAI anxiety | 35.8 score on a scale | Standard Deviation 11.37 |
| Booklet - Preoperative Educational | Levels of Anxiety After Educational Intervention | Pos-op Third visit S-STAI anxiety | 33.90 score on a scale | Standard Deviation 9.41 |
| Booklet - Preoperative Educational | Levels of Anxiety After Educational Intervention | Pos-op Fourth visit S-STAI anxiety | 34.40 score on a scale | Standard Deviation 10.21 |
| Control | Levels of Anxiety After Educational Intervention | Pos-op Fourth visit S-STAI anxiety | 37.20 score on a scale | Standard Deviation 10.46 |
| Control | Levels of Anxiety After Educational Intervention | Pre-operatively S-STAI anxiety | 45.20 score on a scale | Standard Deviation 10.45 |
| Control | Levels of Anxiety After Educational Intervention | Pos-op Third visit S-STAI anxiety | 36.70 score on a scale | Standard Deviation 10.39 |
| Control | Levels of Anxiety After Educational Intervention | Pos -op First visit S-STAI anxiety | 40.10 score on a scale | Standard Deviation 11.24 |
p-value: 0.81Mist Effect Model