An interventional study of Booklet - Preoperative Educational in Malocclusion, Anxiety and Micrognathism, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-01-31.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Health services research
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).
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's enrollment of 48 is above the median of 37 across 242 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients undergoing orthognathic surgery during the study and with surgical technique:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase
Other: Booklet - Preoperative Educational
This group don't received booklet, they will be monitored during the postoperative period to control
the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.
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)
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
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
For the pilot study and testing of the evaluation printed were contacted 8 patients as intervention group and control group not applied.
| Milestone | Booklet - Preoperative Educational | Control |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
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.
| participants | Booklet - Preoperative Educational | Control |
|---|---|---|
| Number of Patients With Clinical Changes During the Postoperative Recovery | 10 | 10 |
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)
| score on a scale | Booklet - Preoperative Educational | Control |
|---|---|---|
| Pos-op First visit | 6.5 ± 1.53 | 4.3 ± 1.94 |
| Pos -op Thrid visit | 6.8 ± 1.64 | 5.0 ± 2.21 |
| Pos-op Fourth visit | 7.00 ± 1.55 | 5.20 ± 2.32 |
| Pre-operatively | 4.20 ± 1.72 | 4.30 ± 2.22 |
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
| score on a scale | Booklet - Preoperative Educational | Control |
|---|---|---|
| Pre-operatively S-STAI anxiety | 39.30 ± 12.13 | 45.20 ± 10.45 |
| Pos -op First visit S-STAI anxiety | 35.8 ± 11.37 | 40.10 ± 11.24 |
| Pos-op Third visit S-STAI anxiety | 33.90 ± 9.41 | 36.70 ± 10.39 |
| Pos-op Fourth visit S-STAI anxiety | 34.40 ± 10.21 | 37.20 ± 10.46 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Booklet - Preoperative Educational | — | 0/20 (0%) | 0/20 (0%) |
| Control | — | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Booklet - Preoperative Educational | Control | Total |
|---|---|---|---|
| <=18 years | 2 | 3 | 5 |
| Between 18 and 65 years | 18 | 17 | 35 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Booklet - Preoperative Educational | Control | Total |
|---|---|---|---|
| Mean | 26.8 ± 8.2 | 27.4 ± 6.9 | 27.1 ± 7.5 |
| Sex: Female, Male(Participants) | Booklet - Preoperative Educational | Control | Total |
|---|---|---|---|
| Female | 9 | 11 | 20 |
| Male | 11 | 9 | 20 |
| Region of Enrollment(participants) | Booklet - Preoperative Educational | Control | Total |
|---|---|---|---|
| Brazil | 20 | 20 | 40 |
Plan to share: No
The record gives a start of Feb 2013, a primary completion of Dec 2014 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2019, 4 years 1 month after primary completion.
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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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