“Preoperative anxiety among adults undergoing surgery - A survey"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 412
- 试验地点
- 1
- 主要终点
- Prevalence of preoperative anxiety, Level of anxiety
研究概览
简要总结
Preoperative anxiety is described as an unpleasantstate of uneasiness or tension that is secondary to a patient being concernedabout a disease, hospitalization, anesthesia, and surgery, or the unknown. Preoperative anxiety ifunallayed is associated with intraoperative haemodynamic changes as well aspostoperative hemodynamic issues, psychological problems, delayed woundhealing, higher chances of infection etc. Though preoperative anxiety has so many negativeimplications, it is often a neglected area. Hence on assessment ofthe presence of anxiety and the level, adequate anxiolytic premedication can beprescribed and thus avoid all thecomplications associated with it. In addition, the relationship betweenanxiety and age, gender, type of surgery, education and socioeconomic statuscan be evaluated, as these may have an influence on the anxiety levels andseverity. The overall prevalenceof preoperative anxiety as reported in some studies is in range of 60–80% butsome researchers showed a wider range, which is 11–80%
There are many studies on the prevalence rates ofpreoperative anxiety among western population, few in Indian population and noneon our local population in our area and hospital. Hence I planned to study thesame.
Aimof the study: Toevaluate the Preoperative anxiety among adults undergoing surgery
Objectivesof the study:
· Primary:Prevalence of preoperative anxiety, Level of anxiety
· Secondary: Effect of age, gender, type of surgery, previoussurgery, education and socioeconomic status on pre-operative anxiety
Materialsand Methods:
· Study design: Prospective, descriptive
· Study Population:
Inclusion criteria: All Adult Patients of ASA – PS classification I and II status above 18 yearsof age undergoing any surgery requiring anaesthesia
**Exclusion criteria:**Patients with ASA – PS classification III physical status or greater, Patientsless than 18 years of age and more than 60 years of age, Unwilling patients,patients with psychiatric disorders on anti‑psychotic drugs,language or communication difficulties, renal or hepatic derangement, lowintelligence quotient.
· Sampling Procedure: Research sample is taken from hospital patients whorequire surgery and who fulfill inclusion and exclusion criteria.
Tocalculate sample size I took Indian studies using similar assessment tests. A sample size of 412 patients is taken, determinedfrom previous studies, where the prevalence of preoperative anxiety wascomputed to be around 58%. The sample size was determined byusing a single proportion for a finite population with assumptions of 95% confidencelevel, marginal error (d) of 5% and the prevalence (P) of 58%, based on theprevious studies. So, this proportionwas used to determine the sample size.
n= Z2 p(1-p)/d2 Where:
n= the desired sample size
Z= standard normal score (at 95% confidence level) Where: Z = 1.96
P= prevalence = (58%) = 0.58
D= degree of accuracy desired marginal error (d) of 5% = 0.05
n= 375.
Considering 10% non-response rate. So Sample size is 412
**Benefitsof the study:**On assessing presence of anxiety and its severity,anxiety reduction methods can be employed to make it more pleasant for thepatient and for a better intra and post-operative outcome. For major surgery, preanaesthetic counselling can be given.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •All Adult Patients of ASA – PS classification I and II status above 18 years of age till 60 years undergoing any surgery requiring anaesthesia.
排除标准
- •Patients with ASA – PS classification III physical status or greater, Patients less than 18 years of age and more than 60 years of age, Unwilling patients, patients with psychiatric disorders on anti psychotic drugs, language or communication difficulties, renal or hepatic derangement, low intelligence quotient.
结局指标
主要结局
Prevalence of preoperative anxiety, Level of anxiety
时间窗: Prevalence of preoperative anxiety, Level of anxiety, both as percentage at baseline using numerical rating scale
次要结局
- Effect of age, gender, type of surgery, previous surgery, education and socioeconomic status on pre-operative anxiety(descriptive)
