Does the Preoperative Anxiety Decrease With BATHE Method? A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 463
- 试验地点
- 2
- 主要终点
- 2 item State Trait Anxiety Intentory (STAI) Score Measure
研究概览
简要总结
The patients were randomized into "Bathe" and "Control" groups by using the closed envelope technique. Demographic data and pre-examination anxiety scores State- Trait Anxiety Inventory (STAI) are recorded as entrance STAI for all patients. Then they had routine preoperative evaluation. During these procedures, Bathe method was applied to the Bathe Group whereas it was not applied to the Control Group. After that post-examination, STAI scores were recorded as exit STAI and the patients were later asked questions about their contentment.
详细描述
Participants and Procedure:
Before the study, approval from the ethics committee of Katip Celebi University Faculty of Medicine was received. 463 patients were included in the prospective randomized double blind study. To accept to be involved in the study, being above 18 years old and being literate were the criteria necessary to be involved in the study. Exclusion criteria were listed as below: Not to accept to be involved in the study, being under 18 years old, being illiterate, having been diagnosed a psychiatric illness, having a physical/psychiatric trauma within the last one year, using sedative, antidepressant, antiepileptic substances or drugs, having cooperation, understanding or hearing problems, belonging to American Society of Anesthesiologists (ASA) physical situation (PS) III and above.
STAI Analysis:
By randomization using the closed envelope technique, the envelopes have been prepared beforehand the patient examination. Sealed envelopes contained a specific number and a patient group defined for this number. Thus, patients were divided into two as 'bathe group' and 'control group' by simple randomization method and they were given one of these closed envelopes respectively.
The demographic data of the patients which included their names-surnames, gender, age, educational background, income level, their previous anesthesia experience (no experience, with general anesthesia experience, with regional anesthesia experience, with both general and regional anesthesia experience) have been questioned. Following this, STAI anxiety questionnaire that was validated to Turkish language by Oner et al., has been applied in order to learn the patients' anxiety levels before preoperative evaluation and the result has been recorded as entrance STAI. Since we aimed to decrease operation anxiety of the patients, we only used state anxiety scale at that moment. After then, patients have been taken to anesthesia examination room.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients >18 years old
排除标准
- •Not to accept to be involved in the study
- •Being illiterate
- •Having been diagnosed a psychiatric illness
- •Having a physical/psychiatric trauma within the last one year
- •Using sedative, antidepressant, antiepileptic substances or drugs
- •Having cooperation, understanding or hearing problems
- •Patients who were ASA PS >III
研究组 & 干预措施
Control group
Standard preoperative evaluation process will continue without any intervention.
Bathe Group
In the comparator group of patients, Bathe method will be applied at preoperative evaluation process.
干预措施: Bathe method: (Other)
结局指标
主要结局
2 item State Trait Anxiety Intentory (STAI) Score Measure
时间窗: 1 hour
State Trait Anxiety Intentory (STAI) Score Measure was applied before BATHE intervention. Then, State Trait Anxiety Intentory (STAI) Score Measure was again applied after BATHE intervention. Then, the change between STAI scores are assessed to understand whether BATHE intervention makes a difference or not.
次要结局
- Patient satisfaction score(1 hour)
研究者
Derya Arslan Yurtlu
Associate Professor Dr, MD
Izmir Ataturk Training and Research Hospital