Primary objective: To evaluate the effect of preoperative anxiety on post-operative pain. 

Secondary objective: To find the association between demographic variables and anxiety levels of the patients. 

METHODOLOGY: 

Study design: A cross-sectional study 

Study participants and centre: Female patients between 20 to 40 years undergoing elective lower segment caesarean section in ESIC hospital. 

Inclusion criteria: Patients undergoing elective lower segment caesarean section under spinal anaesthesia (ASA II) between 20 to 40 years. 

Exclusion criteria: Patients below 20 years and above 40 years ,Patients with known chronic pain disorders ,Patients with known psychiatric disorder ,Patients with ASA status >II , Patients on medications for chronic diseases. 

Sample size and justification: Regression methods - Sample size for correlation coefficient (testing for r = 0)

Sample correlation coefficient .35

Power (1- beta) % 95 

Alpha error (%) 5 

1 or 2 Sided 2 

Required sample size 93 

Preoperative anxiety and postoperative pain were correlated(r=0.35). 

Note: The nMaster (2.0) software has been used to calculate the sample size

From the following calculation, the required sample size is 93 for this study. After considering lost to follow up, sample size is taken to be 100.

Sampling method: Consecutive non-probabilistic sampling 

Study procedure: All patients undergoing elective lower segment caesarean section satisfying the criteria will be enrolled in the study after obtaining their written informed consent. A questionnaire based face to face interview will be conducted before surgery to assess the preoperative anxiety level of the patient. The questionnaire will be translated to the local language of the patients and its linguistic validity will be tested by back translating to English with the help of language experts. The questionnaire will include all demographic details of the patients. APAIS (Amsterdam Preoperative Anxiety and Information Scale) will be used to measure the anxiety level of the patient. APAIS is a self reported questionnaire consisting of 3 components (Anesthesia-related anxiety, Surgery related anxiety and Information desire component). Each component consists of 2 questions making it a total of 6 questions and the response is elicited using five point Likert Scale. The patient should mark the number that shows how anxious she feels at that moment.1=not at all anxious 2=a little anxious 3=moderately anxious 4=very anxious 5=extremely anxious.  In the operating room, during surgery, anaesthesia management will be standardized for all the patients. All patients will receive spinal anaesthesia with 0.5% hyperbaric bupivacaine. After surgery the patient will be shifted to PACU and analgesic regimen will also be standardized for all the patients. The regimen will include i.v. paracetamol (15mg/kg) every sixth hourly. Postoperative pain evaluation will be done every 6 hours after surgery for 24 hours. VAS (Visual Analogue Scale) will be used to measure the pain. It consists of a line with one end representing no pain and another end representing worst pain. The patients will be asked to point to a position in the line that indicates their pain level. Patients complaining of severe pain (VAS >5) will be given 100mg tramadol slow i.v. as rescue analgesia.

Statistical analysis plan: Mean with standard deviation, frequency with percentages will be used to describe the continuous and categorical data respectively. Correlation between preoperative anxiety and postoperative pain will be calculated using Karl Pearson’s correlation coefficient. If data follows normal distribution, an independent t test will be applied to find the mean difference between patients with low and high anxiety. The statistical significance level is considered at p <0.05. The graphs will be presented by using Microsoft Excel. The statistical Analysis will be done by using SPSS (version 21.0).To find the association between demographic variables and anxiety level of patients Chi square test will be used. 

IMPLICATIONS: The expected outcome of the study is that preoperative anxiety and post-operative pain will have a positive correlation. This result will help in enlightening the importance of reducing anxiety in patients before surgery. Many non-pharmacological methods used to reduce anxiety such as meditation, interaction with the doctor, music therapy, imagery, acupuncture which are easy to implement, can be widely used if its correlation is found with pain. This can also lead to promotion of more research on designing interventions for anxiety reduction. Reduction of pain in patients will decrease analgesic consumption and recovery time thereby increasing patient’s satisfaction