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临床试验/NCT06814236
NCT06814236尚未招募不适用

Does Patient's Gender Influence 2-way Communication on Anaesthesia Risk Information-Exchange During Informed Consent Obtention? A Prospective Interview-Based Study

Sir Ganga Ram Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2027年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
Pre-informed Gender

研究概览

简要总结

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.

详细描述

The primary goal of informed consent process is to educate patients about their diagnosis, nature and purpose of proposed treatments, potential risks and benefits, available alternatives, and possible outcomes of declining treatment. Though it promotes patient's autonomy, the process also emphasizes their right to decide about their own care, rather than having decisions made solely by the physician. The informed consent framework is built on three essential pillars:

  1. Effective risk disclosure by the Clinician (Anaesthesiologist)
  2. Patient's perception and understanding of the disclosed risks, including their engagement with the information
  3. Patient's ability to evaluate the information, make informed choices, and express a willingness to proceed based on a balanced understanding of the core context and the possible alternatives.

In contemporary medical practice, the informed consent process frequently does not fulfill these criteria. Several gaps have been identified, including, questions about whether anaesthesiologist perceive risk disclosure as a moral obligation or merely a procedural duty, and whether they genuinely respect patient autonomy.

Current evidence indicates that the goal of truly shared decision-making in the context of risk disclosure remains unexplored. The informed consent process often involves an unidirectional flow of information, where the physician discusses the procedure, risks, and potential outcomes with the patient. However, specific risks associated with anaesthesia are frequently under- communicated, as anaesthesiologists' insights into anaesthesia-related complications are not always integrated into pre-operative discussions. For patient-centric care to be administered at par, it is crucial that the risks associated with surgery and anaesthesia are communicated effectively.

The persistence of challenges in risk communication raises several important questions. Research on doctors' perspectives suggests that inadequate communication skills remain a significant barrier, especially when junior doctors or nurses-often tasked with obtaining consent due to the time constraints of senior staff - may not be adequately trained. Unfortunately, in many healthcare settings, the practice remains largely one-sided, with risk information sharing being an informational "dump" rather than a dialogue. These personnel, lacking the specialized knowledge of anaesthesiologists, might not convey the critical information needed for patients to make fully informed decisions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Males

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

干预措施: Three-Stage Informed Consent Conversation Model for Anaesthesia Risk profiling (Behavioral)

Females

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

干预措施: Three-Stage Informed Consent Conversation Model for Anaesthesia Risk profiling (Behavioral)

结局指标

主要结局

Pre-informed Gender

时间窗: From beginning of preoperative period to beginning of surgery

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nitin Sethi, DNB

Senior Consultant

Sir Ganga Ram Hospital

研究点 (2)

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