TITLE : Assessment of peri operative anxiety in patients undergoing elective surgery. 

BACKGROUND AND JUSTIFICATION 

Perioperative anxiety is a psychological state characterized by fear, nervousness, and apprehension that patients may experience before, during, or after a surgical procedure.(1) For many patients, surgery and anesthesia can be one of the most traumatic situations they face. The waiting period before the surgery has been identified by patients as particularly worrisome, triggering emotional, cognitive, and physiological responses.(2)Preoperative anxiety is known to cause abnormal hemodynamics as a consequence of sympathetic, parasympathetic, and endocrine stimulation, resulting in problems such as difficult venous access, delayed jaw relaxation, coughing during induction of anesthesia, autonomic fluctuations, and increased anesthetic requirements. It has also been correlated with increased pain, nausea and vomiting in the postoperative period, delayed wound healing, increased risk for infection, and ultimately prolonged recovery and lower patient satisfaction.(3)Anxiety may cause behavioural and cognitive changes that result in increased tension, apprehension, nervousness, and aggression.(4)Measuring preoperative anxiety in modern elective surgery is becoming increasingly difficult due to time restrictions. A variety of objective and subjective methods are available for measuring preoperative anxiety, including indirect measurement of sympatheticoadrenal activity using heart rate, blood pressure, or skin conductance. Plasma cortisol, urinary catecholamine excretion, and plasma catecholamines have been used as more direct measures of sympatheticoadrenal activity. Subjective methods include hospital anxiety and depression (HAD), state-trait anxiety inventory (STAI), visual analog scale for anxiety (VAS-A), the Amsterdam preoperative anxiety and information scale (APAIS), multiple affect adjective check list (MAACL), and linear analog anxiety scale (LAAS).(5) The State Trait Anxiety Inventory questionnaire (STAI) is currently considered the gold standard because it has shown consistent results in different populations and ethnic groups in assessing anxiety and is available in various languages.(6,7) As higher anxiety levels have been linked to worse outcomes and courses of treatment, one of the major goals of anesthesia is to reduce perioperative anxiety and improve the patient’s environment and quality of life before, during, and after the operation. 

Perioperative anxiety has significant regional influence worldwide suggested by literature to different personal and cultural factors, quality of social support, and previous experiences with the healthcare system. Therefore large regional studies would be needed for global evaluation of the problem. Furthermore, no studies have been conducted to evaluate the progression of anxiety levels throughout the hospital stay. The findings from this study could have significant implications for future research and patient care. Understanding the prevalence of anxiety and its variations during different stages of hospitalisation can help identify patients who may be at a higher risk for anxiety. This risk stratification can then inform targeted interventions and management strategies to alleviate anxiety and improve patient outcomes. 

OBJECTIVES OF THE STUDY :

 Primary Objective: Anxiety levels from day before surgery to the day of surgery before the procedure  and after the procedure i.e. post operative .
 Secondary Objectives: Various factors influencing the anxiety levels at different time.

INCLUSION/EXCLUSION CRITERIA:

INSTRUMENTS :

To assess anxiety levels, the researchers will use the State-Trait Anxiety Inventory (STAI) T & S short versions containing 10 questions each (licence to administer obtained from Mind Garden ), as well as specific pre operative  anxiety questionnaire (1 question ) and post operative questionnaire (5 questionnaire) developed for this study. These instruments will be administered in three languages: English, Hindi, and Punjabi. Translated versions of the STAI S & T scale and the anxiety questionnaire in Hindi and Punjabi have been obtained from language experts. A score above 44 on the STAI scale will be considered indicative of significant anxiety. The study will utilize a proforma that will collect demographic data such as the patient’s name, age, gender, medical record number, level of education, occupation, and information about any previous surgeries. 

METHODOLOGY :

The procedure for the study involves assessing patients who are scheduled for surgery the next day. The investigator will evaluate their eligibility and visit the recruited patients in the evening after their pre-anesthetic checkup. The purpose of the study, as well as instructions for completing the STAI form and the questionnaire, will be explained to the patients, and their written informed consent will be obtained. The investigator will also record demographic data during this visit. The evaluation process will consist of three assessments. The first assessment (A1) will take place the day before surgery, where patients will be asked to complete the STAI-S form, the STAI-T form, and respond to questions about anxiety in their preferred language. On the day of surgery, in the preoperative area, the second assessment (A2) will be conducted, involving the administration of the STAI-S form. After the surgery, during the postoperative period, the third assessment (A3) will be carried out. During this assessment, patients will complete the STAI-S form again, along with a set of questions about their experiences with anxiety, while their level of consciousness and orientation to time and place will be evaluated.

Sample size calculation 

The global pooled  prevalence  of preoperative anxiety in middle to low income countries  is 48% given by the a system review and meta analysis.

 Assumptions:

Confidence Level = 95%

Precision (d) = ± 10% 

For estimation of sample size, the following formula has been used

n = (Z2α X P X (1-P))/d2

Where;               

Zα = Value of standard normal variate corresponding to α level of significance

P = Likely value of parameter

Q = 1 – P

d = Margin of errors which is a measure of precision

With these assumptions the sample size works out as 96. So we will take around 105 patents to allow 10% drop out rate for study.

LIST OF REFERENCES:

1. Lee, J. H., et al. "Impact of Preoperative Anxiety and Depression on Quality of Recovery in Patients Undergoing Laparoscopic Surgery for Colorectal Cancer." Journal of Clinical Medicine, vol. 8, no. 5, 2019, p. 702.)

2. Sigdel S. Perioperative anxiety: A short review. Glob Anesth Perioper Med. 2015;1(4):107-8.

3. Nigussie S, Belachew T, Wolancho W. Predictors of preoperative anxiety among surgical patients in Jimma University Specialized Teaching Hospital, South Western Ethiopia. BMC Surg. 2014 Sep 5;14:67. doi: 10.1186/1471-2482-14-67. PMID: 25189274; PMCID: PMC4167307  

4. Pritchard Michael John (2009). "Identifying and assessing anxiety in pre-operative patients". Nursing Standard. 23 (51): 35–40. doi:10.7748/ns2009.08.23.51.35.c7222. PMID 19753776

5. Bansal T, Joon A. Preoperative anxiety-an important but neglected issue: A narrative review. Indian Anaesth Forum 2016;17:37-42

6. Tluczek A., Henriques J.B., Brown R.L. Support for the reliability and validity of a six-item state anxiety scale derived from the State-Trait Anxiety Inventory. J. Nurs. Meas. 2009;17(1):19.

7. 20. Kim W.-S., Byeon G.-J., Song B.-J., Lee H.J. Availability of preoperative anxiety scale as a predictive factor for hemodynamic changes during induction of anesthesia. Kor. J. Anesthesiol. 2010;58(4):328.