Evaluation of an Educational Booklet for Perioperative Orthognathic Surgery: Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Number of Patients With Clinical Changes During the Postoperative Recovery
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •patients undergoing reoperation of orthognathic surgery;
- •with cleft lip-palate.
研究组 & 干预措施
Booklet - Preoperative Educational
This group received the booklet in the preoperative consult, they will monitoring during the postoperative phase
干预措施: Booklet - Preoperative Educational (Other)
Control
This group don't received booklet, they will be monitored during the postoperative period to control
结局指标
主要结局
Number of Patients With Clinical Changes During the Postoperative Recovery
时间窗: 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.
次要结局
- 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)
研究者
Cristina Silva Sousa
Student PhD
University of Sao Paulo