跳至主要内容
临床试验/CTRI/2023/11/059561
CTRI/2023/11/059561尚未招募3 期

EFFECT OF VIDEOTAPED INFORMATION ON ANXIETY OF PARENTS WHOSE CHILDREN ARE UNDERGOING ELECTIVE SURGERIES

CMC vellore1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2023年11月14日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
168
试验地点
1
主要终点
Difference In Anxiety Of Parents who watched informative video and routine information using STAI Questainnaire

研究概览

简要总结

The purpose of this study is to evaluate the effect of aneducational video on the anxiety scores of parents whose children are scheduledfor elective surgeries under anaesthesia, and compare it with anxiety scores ofparents provided with verbal information as given routinely.

We propose to conducta non-randomized controlled trial where one group is shown  videotaped information and other group  routine information is shared prior to induction of anaesthesia.  Anxietyscores  of the parents in both groupsprior to elective surgeries is assessed using STAI questionnaire and anxietylevels are compared.Each parent agreeing to be part of the studywill be given a self administered anxiety scoring questionnaire in their ownlanguage based on the STAI to assess their baseline anxiety about their child’supcoming procedure. The participants of the study will be divided into twogroups depending on the week of the elective surgery.. All the eligibleparticipants whose children are scheduled for elective surgery on oneparticular week will be allotted as group 1 where routine preoperativeinformation about the elective surgery will be provided by the concernedanaesthesiologist.

The eligible participants who present on thenext week(alternative weekly) ie  Group 2will be given routine preoperative information as the other group, and thenwill additionally be provided with further detailed  videotaped information (see the appendix) onsafety measures taken during anesthesia; how the anesthesia would beadministered, the drugs used and their possible sideeffects; possible complication of anesthesia and  their interventions; and the post anesthesiaperiod..There is no additional information which is going to be provided invideotaped information when compared to the routine information provided inPAC. .

On the dayprior tosurgery, routine pre procedure information about the anaesthetic procedure for surgerywill be provided to parents by the anaesthesiologists in the operating room asper routine practice.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
1.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • •parents of children aged from 1 to 12 years.

排除标准

  • •Parents will be excluded if they were illiterate, had taken anxiolytic medications in the last 72hours, or have cognitive impairment, sensory impairment or severe mental illness,.

结局指标

主要结局

Difference In Anxiety Of Parents who watched informative video and routine information using STAI Questainnaire

时间窗: Baseline | 5 months

次要结局

  • To access the other causes and factors affecting anxiety in parents of the children undergoing elective surgeries under anesthesia(6 MONTHS)

研究者

发起方
CMC vellore
申办方类型
Private medical college

研究点 (1)

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