Randomised study to know the effectiveness of anaesthesia information sheet on pre-operative anxiety

Not yet recruiting

• Conditions: Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical,

• Registration Number: CTRI/2021/04/032673
• Lead Sponsor: SHRI KRISHNA HOSPITAL

Brief Summary

The study is randomised control trial. Study recruitment would be carried out after ethical approval. Written and informed consent would be taken from participant meeting inclusion and exclusion criteria and will. e randamized into either intervention (group S) or control group (group C).

Preoperative anxiety will be assessed in participants on the day prior to surgery.

Before participants are approached by us, the impression of the participants anxiety level would be rated by the staff nurses using the visual facial anxiety scale.

Pre-operative anxiety will be assessed by using 2 questionnarire visual anxiety scale:

1. VAS for fear of anaesthesia

2. VAS for fear of surgery

Visual anxiety scale questions are rated from 0 to 100, in which 0 means no anxiety and 100 means maximum anxiety.

This would be followed by the question "Are you afriad of anything at present?" IF report Yes, the participant would be asked to elaborate what things they are afriad of? Participant responses would be noted.

Participants in group S would be counselled using an ’anaesthesia information sheet’. This anaesthesia information sheet has details about meaning of anaesthesia, the preparation for anaesthesia, different types of anaesthesia and pros and corns of each method and post-operative care. This would be followed by clarification of the queries using counselling. That i have attached after performa.

Participants in group C will be given information about anaesthesia as per standard of care.

After an interval of 2 hours, anxiety will be reassessed in both the study groups using the 2 quetionnare visual anxiety scale and if VAS score is more than 4 in any of the group, patients will be advised anti anxiety drugs.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-30
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient undergoing major elective surgeries(general surgeries – open and laproscopic hernioplasty,open and laproscopic appendisectomy, hydrocele, open and laproscopic cholecystectomy, speciality surgeries – turp , turbt , mrm , tkr , thr , popliteofemoral bypass, ortho surgeries – radius ulna platting/nailing , pfn , femur sirus nailing , tibia nailing/platting , clavicle platting , rotator cuff repair , arthoscopic knee repair , ob-gy surgeries – ah , lavh , vh , ent surgeries – septoplasty , fess , ear surgeries , dcr).
• Patients aged 18-70 years of either sex.
• Patients having American society of anesthesiology -ASA grade I-III Physical status.
• patients who have studied minimum till standard 5.
• patients understanding one of the languages from Gujarati, Hindi and English.

Exclusion Criteria

• patients having known psychiatric disorder.
• patients taking anti-anxiety drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pre operative anxiety is still unrecognized entities in large number of cases. The results of this study will help us establish whether information sheet and thus visual alongwith verbal communication is useful in reducting anxiety in patients. If it is reliable approach to reduce stress and anxiety and provide comfortable ambience to patient.	Pre operative anxiety will be reassessed after 2 hours of counseling.

Trial Locations

Locations (1)

shree krishna hospital; 🇮🇳 Anand, GUJARAT, India

shree krishna hospital

🇮🇳Anand, GUJARAT, India

krupa sutaria

Principal investigator

19909784164

krupa.sutaria@gmail.com