MalocclusionNCT01803204
Patient Education Before Orthognathic Surgery
A study testing Booklet - Preoperative Educational in people with Malocclusion and Anxiety, run by University of Sao Paulo at 1 site in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Malocclusion, Anxiety, Micrognathism
- What is being tested?
- Booklet - Preoperative Educational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- patients undergoing reoperation of orthognathic surgery;
- with cleft lip-palate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Educational Booklet for Perioperative Orthognathic Surgery: Randomized Clinical Trial.
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
Read the 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).
- Conditions
- Malocclusion, Anxiety, Micrognathism, Prognathism
- Being tested
- Booklet - Preoperative Educational
- Keywords
- Anxiety, Orthognathic surgery, Patient educational as topic, Patient educational handout, Pamphlets
- Medical subject headings
- Malocclusion, Anxiety Disorders, Micrognathism, Prognathism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Booklet - Preoperative EducationalOther
the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Booklet - Preoperative Educational | Experimental | This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase Receives: Other: Booklet - Preoperative Educational |
| Control | No intervention | This group don't received booklet, they will be monitored during the postoperative period to control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Secondary outcomes (1)
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)
Measured: This will be delivered in the first contact with the patient before surgery and on the seventh day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Silva Sousa, University of Sao Paulo
- Investigators
- Cristina S Sousa, MsC, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803204
- Sponsor's protocol ID
- 193.454
- Status last verified
- Aug 2018
- First submitted
- 25 Feb 2013
- Last updated
- 31 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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. doi: 10.1590/s0080-62342012000700012. Portuguese.
PubMed 23250262Sousa 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.
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.
PubMed 25031119Sousa CS, Turrini RNT. Complications in orthognathic surgery: A comprehensive review. Journal of Oral and Maxillofacial Surgery, Medicine, and Pathology. 2012;24:67-74.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Educational Booklet for Perioperative Orthognathic Surgery: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01803204
- Acronym / sponsor ID
- 193.454
- Conditions
- Malocclusion, Anxiety, Micrognathism, Prognathism
- Keywords
- Anxiety, Orthognathic surgery, Patient educational as topic, Patient educational handout, Pamphlets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Posted 31 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Booklet - Preoperative Educational | Experimental | Other: Booklet - Preoperative EducationalThis 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients undergoing orthognathic surgery during the study and with surgical technique:
- Informed consent
- Patients in the maxillofacial outpatient clinic located at Sao Paulo
Key exclusion criteria (2 listed)
- patients undergoing reoperation of orthognathic surgery;
- with cleft lip-palate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Booklet - Preoperative Educationalthe patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery. | Other | Booklet - Preoperative Educational |
Primary outcome
Number of Patients With Clinical Changes During the Postoperative Recovery
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)
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.
1 secondary outcome
Average Test Arrangements on Surgery
Time frame: This will be delivered in the first contact with the patient before surgery and on the seventh day after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23250262dos 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.
- BackgroundSousa 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.
- Background: PubMed 25031119Sousa 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.
- BackgroundSousa CS, Turrini RNT. Complications in orthognathic surgery: A comprehensive review. Journal of Oral and Maxillofacial Surgery, Medicine, and Pathology. 2012;24:67-74.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina S Sousa, MsC principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Booklet - Preoperative Educational in people with Malocclusion and Anxiety, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Clinical Changes During the Postoperative Recovery (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01803204, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.