Patient Education Before Orthognathic Surgery

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT01803204
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 30.9
• Patients Per Site Per Month: 1.6

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Malocclusion; Anxiety; Micrognathism; Prognathism	Other: Booklet - Preoperative Educational	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Evaluation of an Educational Booklet for Perioperative Orthognathic Surgery: Randomized Clinical Trial.
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Booklet - Preoperative Educational This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase	Other: Booklet - Preoperative Educational; the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.
No Intervention: Control This group don't received booklet, they will be monitored during the postoperative period to control

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cristina Silva Sousa	Sao Paulo		Brazil	04116020

Sponsors and Collaborators

• University of Sao Paulo

Investigators

• Principal Investigator: Cristina S Sousa, MsC, University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Portuguese.
• 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.
• Sousa CS, Turrini RNT. Complications in orthognathic surgery: A comprehensive review. Journal of Oral and Maxillofacial Surgery, Medicine, and Pathology. 2012;24:67-74.
• 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.

• Responsible Party: Cristina Silva Sousa, Student PhD, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT01803204
• Other Study ID Numbers: 193.454
• First Posted: Mar 4, 2013
• Last Update Posted: Jan 31, 2019
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Cristina Silva Sousa, Student PhD, University of Sao Paulo: Anxiety; Orthognathic surgery; Patient educational as topic; Patient educational handout; Pamphlets
• Additional relevant MeSH terms: Prognathism; Micrognathism; Malocclusion

Study Results

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.

Arm/Group Title	Booklet - Preoperative Educational	Control
Arm/Group Description	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.	This group don't received booklet, they will be monitored during the postoperative period to control
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Booklet - Preoperative Educational	Control	Total
Arm/Group Description	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.	This group don't received booklet, they will be monitored during the postoperative period to control	Total of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	2 10%	3 15%	5 12.5%
Between 18 and 65 years	18 90%	17 85%	35 87.5%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.8 (8.2)	27.4 (6.9)	27.1 (7.5)
Sex: Female, Male (Count of Participants)
Female	9 45%	11 55%	20 50%
Male	11 55%	9 45%	20 50%
Region of Enrollment (participants) [Number]
Brazil	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Booklet - Preoperative Educational	Control
Arm/Group Description	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.	This group don't received booklet, they will be monitored during the postoperative period to control
Measure Participants	20	20
Number [participants]	10 50%	10 50%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Booklet - Preoperative Educational, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	GEE
	Comments
Method of Estimation	Estimation Parameter	GEE
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 99%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Booklet - Preoperative Educational	Control
Arm/Group Description	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.	This group don't received booklet, they will be monitored during the postoperative period to control
Measure Participants	20	20
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Booklet - Preoperative Educational, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Mist Effects Model
	Comments

3. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Booklet - Preoperative Educational	Control
Arm/Group Description	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.	This group don't received booklet, they will be monitored during the postoperative period to control
Measure Participants	20	20
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Booklet - Preoperative Educational, Control
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.81
	Comments
	Method	Mist Effect Model
	Comments

Adverse Events

Time Frame	2 years
Arm/Group Title	Booklet - Preoperative Educational		Control
Arm/Group Description	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.		This group don't received booklet, they will be monitored during the postoperative period to control
All Cause Mortality
	Booklet - Preoperative Educational		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Booklet - Preoperative Educational		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Booklet - Preoperative Educational		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.