Patients Gender Influence on Communication of Anaesthesia Risk
ConditionAnaesthesia Complication
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-60
SponsorSir Ganga Ram Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and Female patients
Posted for short-2-moderate duration surgery
Willing to participate
Education > Bachelors degree
Disqualifiers
Patients posted for major surgery
Patients in for emergency surgery
ASA III-IV physical grade.
Patients refusing recording of the interview
Trial population
Patients undergoing elective surgical procedure under anaesthesia
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Three-Stage Informed Consent Conversation Model for Anaesthesia Risk profiling
BehavioralStage 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Males1 intervention
Group B: Females1 intervention
Trial outcomes
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
Time frame
From beginning of preoperative period to beginning of surgerySecondary outcomes
1
Gender Curosity For Anesthesia Risk Factors
Based on 3-stage informed consent conversation model it will be assessed which gender 'male' or 'female' actively engages with the physician for his/her curiosity regarding anaesthesia risk factors not known to them
Time frame
From beginning of preoperative period to beginning of surgery2
Gender Perusal for Anaesthesia & Surgical Risk Details
Based on 3-stage informed consent conversation model it will be assessed which gender 'male' or 'female' actively seeks to get full details of the probable risk involved in anaesthesia and surgery
Time frame
From beginning of preoperative period to beginning of surgery3
Doctor-patient relationship type
Based on 3-stage informed consent conversation model it will be assessed what type of doctor-patient relationship (paternalistic, fiduciary, shared decision-making) is established when comparing 'male' and 'female' gender.
Time frame
From beginning of preoperative period to beginning of surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: