Trial Outcomes & Findings for Patient Education Before Orthognathic Surgery (NCT NCT01803204)
NCT ID: NCT01803204
Last Updated: 2019-01-31
Results Overview
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.
COMPLETED
NA
48 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)
2019-01-31
Participant Flow
For the pilot study and testing of the evaluation printed were contacted 8 patients as intervention group and control group not applied.
Participant milestones
| Measure |
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.
|
Control
This group don't received booklet, they will be monitored during the postoperative period to control
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient Education Before Orthognathic Surgery
Baseline characteristics by cohort
| Measure |
Booklet - Preoperative Educational
n=20 Participants
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.
|
Control
n=20 Participants
This group don't received booklet, they will be monitored during the postoperative period to control
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 8.2 • n=99 Participants
|
27.4 years
STANDARD_DEVIATION 6.9 • n=107 Participants
|
27.1 years
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Booklet - Preoperative Educational
n=20 Participants
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.
|
Control
n=20 Participants
This group don't received booklet, they will be monitored during the postoperative period to control
|
|---|---|---|
|
Number of Patients With Clinical Changes During the Postoperative Recovery
|
10 participants
|
10 participants
|
SECONDARY outcome
Timeframe: This will be delivered in the first contact with the patient before surgery and on the seventh day after surgeryThe 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)
Outcome measures
| Measure |
Booklet - Preoperative Educational
n=20 Participants
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.
|
Control
n=20 Participants
This group don't received booklet, they will be monitored during the postoperative period to control
|
|---|---|---|
|
Average Test Arrangements on Surgery
Pre-operatively
|
4.20 score on a scale
Standard Deviation 1.72
|
4.30 score on a scale
Standard Deviation 2.22
|
|
Average Test Arrangements on Surgery
Pos-op First visit
|
6.5 score on a scale
Standard Deviation 1.53
|
4.3 score on a scale
Standard Deviation 1.94
|
|
Average Test Arrangements on Surgery
Pos -op Thrid visit
|
6.8 score on a scale
Standard Deviation 1.64
|
5.0 score on a scale
Standard Deviation 2.21
|
|
Average Test Arrangements on Surgery
Pos-op Fourth visit
|
7.00 score on a scale
Standard Deviation 1.55
|
5.20 score on a scale
Standard Deviation 2.32
|
OTHER_PRE_SPECIFIED outcome
Timeframe: The STAI will be applied on the seventh day after surgeryThe 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
Outcome measures
| Measure |
Booklet - Preoperative Educational
n=20 Participants
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.
|
Control
n=20 Participants
This group don't received booklet, they will be monitored during the postoperative period to control
|
|---|---|---|
|
Levels of Anxiety After Educational Intervention
Pos-op Third visit S-STAI anxiety
|
33.90 score on a scale
Standard Deviation 9.41
|
36.70 score on a scale
Standard Deviation 10.39
|
|
Levels of Anxiety After Educational Intervention
Pre-operatively S-STAI anxiety
|
39.30 score on a scale
Standard Deviation 12.13
|
45.20 score on a scale
Standard Deviation 10.45
|
|
Levels of Anxiety After Educational Intervention
Pos -op First visit S-STAI anxiety
|
35.8 score on a scale
Standard Deviation 11.37
|
40.10 score on a scale
Standard Deviation 11.24
|
|
Levels of Anxiety After Educational Intervention
Pos-op Fourth visit S-STAI anxiety
|
34.40 score on a scale
Standard Deviation 10.21
|
37.20 score on a scale
Standard Deviation 10.46
|
Adverse Events
Booklet - Preoperative Educational
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place