跳至主要内容
临床试验/CTRI/2014/06/004649
CTRI/2014/06/004649招募中不适用

A study to assess whether planned pre-operative education decreases anxiety and improves satisfaction in patients undergoing surgery-A randomised controlled trial

MOSC MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2014年8月5日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
64
试验地点
1
主要终点
ANXIETY MEASURED USING AMSTERDAM PRE-OPERATIVE ANXIETY INFORMATION SCALE(APAIS)

研究概览

简要总结

In this study in patients undergoing fibroid surgery we hope to assess whether planned pre-operative education using principles of effective communication relieves anxiety and improves patient satisfaction.All patients in the age group 30-55 years, admitted for fibroid surgery in the gynaecology ward of this Medical College who have already received counselling from the treating physician, will be eligible to participate in the study .Patients who give written informed consent and fulfill the inclusion criteria will be randomised by permuted block randomisation to two groups -Group X and Group Y. Planned pre-operative education (PPE) standardised to include information regarding surgery,assurance regarding competence of doctors will be given to patients in Group X while Group Y will not receive PPE. The Amsterdam Pre-operative Anxiety and Information Scale (APAIS) has been shown to be a valid, reliable and easily applicable instrument for assessing the patient’s pre-operative anxiety and need for information. Anxiety will be assessed using APAIS by the investigator on admission and demographic data will be collected.PPE will be administered to Group X. A blinded assessor will assess anxiety on the day prior to surgery.  Patient Satisfaction Questionnaire Short form(PSQ-18) is a concise validated tool that can be applied to various settings.Patient satisfaction will be assessed by the investigator using  this tool prior to discharge.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
30.00 Year(s) 至 55.00 Year(s)(—)
性别
Female

入选标准

  • WOMEN ADMITTED FOR FIBROID SURGERY IN A PRIVATE MEDICAL COLLEGE.

排除标准

  • ALL MEDICAL PROFESSIONALS ADMITTED FOR FIBROID SURGERY.

结局指标

主要结局

ANXIETY MEASURED USING AMSTERDAM PRE-OPERATIVE ANXIETY INFORMATION SCALE(APAIS)

时间窗: ANXIETY MEASURED PRE-OPERATIVELY ON DAY BEFORE SURGERY

次要结局

  • PATIENT SATISFACTION ASSESSED BY PATIENT SATISFACTION QUESTIONNAIRE SHORT FORM-18(PSQ-18)(PATIENT SATISFACTION ASSESSED ON THE SECOND DAY AFTER SURGERY.)

研究者

申办方类型
Private medical college

研究点 (1)

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