CTRI

Secondary objectives:

1. To assess the difference in preoperative anxiety levels on the day of surgery between verbal counselling using AIS versus video-based counselling.

2. To compare patient satisfaction related to counselling method in both the groups

3. To evaluate the feasibility and acceptability of implementing video-based counselling technique among residents in a clinical preoperative setting.

METHODOLOGY

ETHICAL CONSIDERATION

This Study will be conducted after obtaining Ethical Approval by Local Ethical committee of GMERS Medical College and Hospital, Gotri, Vadodara and topic being registered with CTRI (Clinical Trial Registry of India).

This study will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and relevant national ethical guidelines for biomedical research. A written informed consent form will be provided in a language understandable to the participant. Consent will be obtained voluntarily before any study-related procedures are performed. Participant confidentiality will be strictly maintained throughout the study.

STUDY DESIGN

This is a prospective, randomized, controlled study with two parallel arms comparing counselling with written information sheets and video-based counselling in patients undergoing elective surgeries.

STUDY PLACE

The study will be conducted at the tertiary care hospital (GMERS Medical College and Hospital, Vadodara).

STUDY DURATION

The study is expected to be completed over a 3–6 month period, commencing after obtaining Institutional Ethics Committee approval.

STUDY POPULATION

Adult patients scheduled for elective surgery under either general or regional anesthesia, will be eligible for inclusion in the study.

INCLUSION CRITERIA

Age: 18-65 years of either sex

American Society of Anesthesiologists (ASA) physical status I and II

Can read and able to comprehend study-related material in any one from Gujarati and English

EXCLUSION CRITERIA

Diagnosed psychiatric illness or current psychiatric, anti-anxiety medication use

Alcohol intake within past one month

Patients with confirmed pregnancy

Patient with visually and auditory disabled

History of surgical exposure within the past 12 months

Refusal to participate in the study

RANDOMIZATION

Participants will be randomly assigned using computer-generated randomization into one of the following two groups:

Group A: Verbal Counselling with Written Anesthesia Information Sheet

Group B: Video-Based Counselling

Allocation concealment will be maintained using sealed opaque envelopes.

STUDY PROCEDURE

Group A (Verbal Counselling with AIS): Patients will receive verbal counselling with the Anesthesia Information Sheet (AIS) by the anesthesia resident, containing details of anesthesia procedures and perioperative care.

Group B (Video-Based Counselling): Patients will be provided with 4-5 minute video with animations and voice-over explaining anesthesia-related procedures and safety measures.