Patients Gender Influence on Communication of Anaesthesia Risk

NCT06814236 | Not Yet Recruiting

• 1 other identifier: EC/11/24/2618
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

In Anaesthesia Practice, an Informed consent involves discussing the risks and benefits involved with a certain procedure and its alternatives. Though it is intended to promote patient autonomy and enhance decision-making, the risk profiling, detailing and discussing; generally walks one-way, from the anaesthesiologist to patient/party. This monologue-leaned communication is neither free flowing nor the patients are allowed to 'speak-up-first' on their concerns or queries. Several gaps can be identified including reluctance on the part of the anaesthesiologist to engage the patients in decision making or not upholding the patient preferences; or patient lacking sufficient knowledge to make an informed choice. Therefore, for risk communication, the very context has to be tailored to patient's individual needs. There is no available study till date which has tried to address as how the communication between patient and the anaesthesiologist is influenced by the 'gender' of the patient concerned. This situates a need to understand how the 'gender' of a patient can influence communication during an Informed consent conversation on anaesthesia risk(s). The study will explore to decipher if difference(s) in patient's gender influence their perceptions and understanding of anesthesia-related risks, and if the difference will influence the future lines of communication involving either of the gender. This prospective study will be based on conversation model based interview designed to assess the nuances of gender- based differences in risk perception and information exchange during pre-anaesthetic consultations.

Conditions

Anaesthesia Complication

Keywords

gender; anaesthesia risk; informed consent

Outcome Measures

Primary Outcomes (1)

• Pre-informed Gender

  Based on 3-stage informed consent conversation model it will be assessed which gender 'male' or 'female' is pre-informed about anaesthesia concerns and risks when asked

  From beginning of preoperative period to beginning of surgery

Secondary Outcomes (3)

• Gender Curosity For Anesthesia Risk Factors

  From beginning of preoperative period to beginning of surgery

• Gender Perusal for Anaesthesia & Surgical Risk Details

  From beginning of preoperative period to beginning of surgery

• Doctor-patient relationship type

  From beginning of preoperative period to beginning of surgery

Study Arms (2)

Males

Patients undergoing elective short-to-moderate duration surgery will be administered a questionnaire based interview at the time of obtaining informed consent

Behavioral: Three-Stage Informed Consent Conversation Model for Anaesthesia Risk profiling

Females

Patients undergoing elective short-to-moderate duration surgery will be administered a questionnaire based interview at the time of obtaining informed consen

Behavioral: Three-Stage Informed Consent Conversation Model for Anaesthesia Risk profiling

Interventions

Three-Stage Informed Consent Conversation Model for Anaesthesia Risk profiling BEHAVIORAL

Stage 1 Pre-information queries Do you know about the risks involved in Anaesthesia? If yes, where did you get information about the risks involved with Anaesthesia?? Which of these do you already know of and what concerns you most? Why are you concerned more about that particular risk factor? Stage 2 Informing Risks The probability or chances of supposed anaesthesia risks could be: Probable risk Possible risk Remote risk We have the following risk management strategy in place for your reassurance and safety: Employing ERAS protocol The surgery you are going to undergo, also may have its own set of risks Stage 3 Post-information Informing Risks In view of the above conversation we had, do you have other point of concern or query on what we have talked about.

Females; Males

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients undergoing elective surgical procedure under anaesthesia

You may qualify if:

• Male and Female patients
• Posted for short-2-moderate duration surgery
• Willing to participate
• Education \> Bachelors degree
• ASA -I \& II physical grade

You may not qualify if:

• Patients posted for major surgery
• Patients in for emergency surgery
• ASA III-IV physical grade.
• Patients refusing recording of the interview
• Those looking to their family members to decide upon whether to participate in study • Patients agreeing to recording of the interview but refusing the recorded interview to be evaluated

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (2)

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Jyotsana Sharma, MSc

  Sir Ganga Ram Hospital, New Delhi-110060, India

  PRINCIPAL INVESTIGATOR

• Amitabh Dutta, MD

  Sir Ganga Ram Hospital, New Delhi-110060, India

  STUDY DIRECTOR

Central Study Contacts

Nitin Sethi, DNB

CONTACT

00919717494498; nitinsethi77@yahoo.co.in

Amitabh Dutta, MD

CONTACT

00919810848064; duttaamitabh@yahoo.co.in

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 7, 2025
• Study Start (Estimated): December 1, 2027
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)