跳至主要内容
临床试验/CTRI/2016/08/007214
CTRI/2016/08/007214已完成不适用

Audit of anxiety levels in preoperative period in surgical patients in medical institute

Self1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2014年8月25日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
Self
入组人数
84
试验地点
1
主要终点
To evaluate reduction in anxiety levels on the day before surgery as regards to the information known by the patient regarding the diagnosis, surgical procedure, and anesthesia before preoperative assessment and after providing them the information for the same

研究概览

简要总结

Anxiety is common in surgical patients during the preoperative period. High levels of preoperative anxiety may have unfavorable effects on induction and maintenance of anaesthesia as well as on the recovery from anaesthesia and surgery. Anxious patients may require higher doses of anaesthetic induction agents and postoperative analgesic drug.

Primary Objective: To evaluate reduction in anxiety levels on theday before surgery as regards to the information known by the patient regardingthe diagnosis, surgical procedure, and anesthesia before preoperative assessment and after providingthem the information for the same

Secondary Objective: To determine the factors responsible forpreoperative anxiety in surgical patients in Hospital

After noting basic demography, SECTION1 of questionaire consists of three questions to know the information patients have about thediagnosis, upcoming surgery procedure, type of anesthesia to be provided while SECTION 2 has a list of 16 questions relating toanxiety. The participants will select different factors responsible for theiranxiety from this list. The level of patients’ anxiety assessed with the visualanalogue scale (VAS). Eachparticipant will in addition be requested to make an assessment of averagepersonal level of anxiety to be assessed by VAS score.

The patient will be randomly allotted one ofthe two groups. The study group and control group. The study group will receivethe information about the diagnosis, the surgery to be performed, and the typeof anaesthesia. The control group will not be given any information.

The average personal level of anxiety of thepatient will again be assessed with VAS score in both the groups. To find out the incidence of preoperativeanxiety by VAS of the 16 factors. A score of at least 45mm on the VAS will be regarded as significant anxietyfor each factor Maximum value -1500 Minimum value- 0 Significant anxiety-675

To determine the influence of gender, age,educational level and previous surgical treatment on anxiety using appropriatestatistical tests.

The study will be conducted in 84 subjects and appropriate statistical analysis will be done.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult ASA 1 and 2 Age between 18 -65 years Undergoing various elective surgeries.

排除标准

  • Pregnancy Transplant surgery Neurological diseases Aged under 18 or older than 65 Known psychiatric illness Patients on anxiolytic medication Those unable to read.

结局指标

主要结局

To evaluate reduction in anxiety levels on the day before surgery as regards to the information known by the patient regarding the diagnosis, surgical procedure, and anesthesia before preoperative assessment and after providing them the information for the same

时间窗: Before pre-anaesthetic assessment on the day prior to surgery before visiting hours

次要结局

  • To determine the factors responsible for preoperative(anxiety in surgical patients in Hospital)

研究者

发起方
Self
申办方类型
Other []

研究点 (1)

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