Assessment of preoperative anxiety in Burn patient posted for Surgery – A Single Centre Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Outcome parameters:
研究概览
简要总结
INTRODUCTION
Preoperative anxiety is a significant concern in burn patients, who are not only physically debilitating but also emotionally distressing. Burn injuries, caused by heat, chemicals, electrical current, or radiation, have a significant impact on the sufferer’s mental, psychological, and physical health. Factors contributing to preoperative anxiety include the nature and extent of the burn, potential disfigurement, fear of pain, and concerns about the surgical outcome. Assessment tools like the Hospital Anxiety and Depression Scale (HADS) and the State-Trait Anxiety Inventory (STAI) are essential for effective evaluation. Burn-specific tools like the Burn Specific Health Scale-Brief (BSHS-B) can provide insights into the emotional impact of burn injuries and aid in assessing preoperative anxiety. Clinical interviews are also crucial in assessing anxiety, allowing healthcare providers to explore individual concerns and tailor interventions accordingly. Preoperative anxiety in surgical patients imposes stress and dissatisfaction, leading to altered neuroendocrine response and various perioperative complications. Anxiety is an unpleasant emotional experience involving tension, apprehension, nervousness, and high autonomic activity. Extreme anxiety prior to surgery has been shown to lead to cardiovascular disturbances such as tachycardia, hypertension, arrhythmias, and increased postoperative pain. A tailored and comprehensive approach is needed to assess preoperative anxiety in burn patients scheduled for surgery. Utilizing standardized tools and incorporating burn-specific considerations in both assessment and intervention contributes to better understanding and addressing the emotional challenges faced by these patients, ultimately enhancing their overall surgical experience and recovery.
AIMS AND OBJECTIVES
Aims:
This study will be conducted to determine the changes in anxiety level and need for information about the anesthetic and the surgical procedures at3different time points before surgery in burn patients and to evaluate the correlating factors. Level of anxiety and need for information will be assessed with the Amsterdam Preoperative Anxiety and Information Scale
Amsterdam Preoperative Anxiety and Information Scale
The Amsterdam Preoperative Anxiety and Information Scale (APAIS) was developed, particularly for the preoperative patients, measures anxiety level, and need for information about surgery and anesthesia.
This study is designed to evaluate and quantify anxiety in burn patients scheduled for surgery based on the APAIS scoring
MATERIAL AND METHODS
Study setting ; The studywill be conducted in the Department of Anaesthesiology, in collaboration with Department of Plastic Surgery,King George’s Medical University, Lucknow
Ethical Clearance : Approved, Research Cell, KGMU, Lucknow
Study duration- One and half year
Study design- Prospective observational study
Sample size - 250
INCLUSION CRITERIA:
· Age between 18 years to 60 years
· Patient of ASA physical status class1 and class 2 of either sex
· Patient admitted at least 1 day before the scheduled surgical procedure.
· Patient giving informed and written consent
EXCLUSION CRITERIA:
· Patient with any psychiatry diseases or mental retardation.
· Patient taking anti-anxiety anti-depressant or medication
· Patient suffering from any malignant condition
· Patient not giving consent
Methods:
The study to evaluate and quantify anxiety levels in adult burn patients scheduled for surgery at King George’s Medical University, Lucknow over a period of one and a half years. The Amsterdam Preoperative Anxiety and Information Scale (APAIS) was developed to measure anxiety level and need for information about surgery and anesthesia. The primary outcome is to determine changes in anxiety level and need for information about anesthesia and surgery among the patients at three different time points preoperatively: evening before surgery, in the ward (T1), on the day of surgery, in the preoperative holding area (T2), and in the operating room after being positioned on the operating table (T3). The secondary outcome includes analyzing variables that can affect anxiety, such as age, sex, American Society of Anesthesiologists (ASA) Physical Status, level of education, profession, residential background, history of previous surgery, and serial number on the operation list. The study will also assess anxiety levels related to various types of burns, surgeries performed, and type of anesthesia administered. Patients underwent routine preoperative counseling in the outpatient department by the surgeon and another anesthesiologist, and each patient was asked to read the APAIS questionnaire consisting of six questions translated into local language Hindi. The measure of agreement with these statements was graded on a 5-point Likert scale, from 1 = not at all to 5 = extremely. No further counseling was done during this process. Outcome parameters will be assessed from the tables, including total anxiety score, anesthesia-related anxiety score, surgery-related anxiety score, and need for information score. The study aims to provide valuable insights into the factors affecting anxiety levels and the need for information about burn patients.
PRIMARY OUTCOME
To determine Changes in anxiety level at 3different time point using Amsterdam Preoperative Anxiety and Information Scale
1.Evening before surgery
2.Morning of surgery (preoperative area)
3.On OT table, in the operating table prior to anesthesia and surgery
SECONDARY OUTCOME
A. To determine the correlation between anxiety level before surgery and demographic
1.Age
-
Sex
-
ASA
-
Education
-
Profession
6 Residence
1. History of previous surgery
2. Serial number on operating list
B. To determine the correlation between anxiety level before surgery and related to burn
-
Mode of burns(thermal/electrical/chemical)
-
Percentage of burn
-
Facial and neck burns
-
Acute burns less than 2 months in ICU posted for surgery
5 Chronic burns more than 2 months posted for surgery
C. To determine the correlation between anxiety level before surgery and type of surgery performed
-
Debridement
-
Fasciotomy
-
Split skin grafting
-
Amputation
D. To determine the correlation between anxiety level before surgery and type of anaesthesia performed
-
Monitored anaesthesia care
-
Spinal anaesthesia
-
General anaesthesia
Amsterdam Preoperative Anxiety and Information Scale
The Amsterdam Preoperative Anxiety and Information Scale (APAIS) will be developed, particularly for the preoperative patients, measures anxiety level, and need for information about surgery and anesthesia. This study will be designed to evaluate andquantify anxiety in burn patients scheduled for surgery based on the APAIS scoring
QUESTIONS The Amsterdam preoperative
Anxiety and information scale
1 I am worried about the anesthetic 1 2 3 4 5
2.The anesthetic is on my mind 1 2 3 4 5
continually
3.I would like to know as much as 1 2 3 4 5
possible about the anesthetic
4.I am worried about the procedure 1 2 3 4 5
5.The procedure is on my mind 1 2 3 4 5
Continual
6.Iwould like to know as much as 1 2 3 4 5
possible about the procedure
1: Not at all
2: Somewhat
3: Moderate
4: Moderately high
5: Extremely
The measure of agreement with these statements was graded on a 5 point Likert scale, from 1 not at all to 5 extremely. The patients were asked to put tick mark where appropriate and sign the consent form. No further counseling was done with the patients during this process.
Outcome parameters:
1. Total anxiety score= sum of responses of items 1,2,4 and 5
2. Anesthesia – related anxiety score = sum of responses of items 1 and 2
3. Surgery related anxiety score = sum of responses of items 4 and 5
4. Need for information score = sum of responses of items 3 and 6
Statistical analysis
Statistical analysis will be performed by the SPSS version 24th version. Statistical analysis for the assessment of preoperative anxiety in burn patients will involve descriptive statistics to summarize demographics and anxiety levels. Preoperative anxiety scores will be compared using paired t tests or Wilcoxon signed-rank tests for related samples, depending on data distribution. Correlation analysis may be performed to assess relationships between anxiety scores and demographic variables. A significance level of p less than 0.05 will be set for all tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •• Age between 18 years to 60 years • Patient of ASA physical status class1 and class 2 of either sex • Patient admitted at least 1 day before the scheduled surgical procedure.
- •• Patient giving informed and written consent.
排除标准
- •• Patient with any psychiatry diseases or mental retardation.
- •• Patient taking anti-anxiety anti-depressant or medication • Patient suffering from any malignant condition • Patient not giving consent.
结局指标
主要结局
Outcome parameters:
时间窗: Outcome parameters: | 1. Total anxiety score= sum of responses of items 1,2,4 and 5 | 2. Anesthesia – related anxiety score = sum of responses of items 1 and 2 | 3. Surgery related anxiety score = sum of responses of items 4 and 5 | 4. Need for information score = sum of responses of items 3 and 6
1. Total anxiety score= sum of responses of items 1,2,4 and 5
时间窗: Outcome parameters: | 1. Total anxiety score= sum of responses of items 1,2,4 and 5 | 2. Anesthesia – related anxiety score = sum of responses of items 1 and 2 | 3. Surgery related anxiety score = sum of responses of items 4 and 5 | 4. Need for information score = sum of responses of items 3 and 6
2. Anesthesia – related anxiety score = sum of responses of items 1 and 2
时间窗: Outcome parameters: | 1. Total anxiety score= sum of responses of items 1,2,4 and 5 | 2. Anesthesia – related anxiety score = sum of responses of items 1 and 2 | 3. Surgery related anxiety score = sum of responses of items 4 and 5 | 4. Need for information score = sum of responses of items 3 and 6
3. Surgery related anxiety score = sum of responses of items 4 and 5
时间窗: Outcome parameters: | 1. Total anxiety score= sum of responses of items 1,2,4 and 5 | 2. Anesthesia – related anxiety score = sum of responses of items 1 and 2 | 3. Surgery related anxiety score = sum of responses of items 4 and 5 | 4. Need for information score = sum of responses of items 3 and 6
4. Need for information score = sum of responses of items 3 and 6
时间窗: Outcome parameters: | 1. Total anxiety score= sum of responses of items 1,2,4 and 5 | 2. Anesthesia – related anxiety score = sum of responses of items 1 and 2 | 3. Surgery related anxiety score = sum of responses of items 4 and 5 | 4. Need for information score = sum of responses of items 3 and 6
次要结局
- BilBil(Bil)
研究者
Obenthung Obdyuo
King Georges Medical University Lucknow
