跳至主要内容
临床试验/CTRI/2017/10/009980
CTRI/2017/10/009980招募中不适用

Perioperative anxiety and stress in children and parents undergoing congenital cardiac surgery: Effect of brief intervention

All India Institute Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
1. Effect of video, games and toys on relieving stress, anxiety, pain and improving mood in children undergoing cardiac surgery.

研究概览

简要总结

Intoduction: Majoradvances in surgical treatment have improved outcomes for children with congenital heart disease.More attention is now being placed on the developmental and psychologicaloutcomes of these children, realizing that any form of cardiac surgery is amajor stress for children and their families. Children and their parents develop significantbehavioral stress and anxiety before  surgery.

Methodoly: Thisstudy includes 60 children with CHD undergoing elective cardiac surgery in theage group 5 to 15 years. Parents will be selected from their respectivechildren for this study. Study includes three time assessments of both childrenand parents. intervention in the form of games and toys given for children before anaesthesia and hospital education for respective children in intervention group of the study. Assessment of stress, anxiety and mood will be assessed for bothchild and parent. Painwill be assessed in child. Serum cortisol levels will be measured in childrenbefore and after surgery.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
5.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • •Children undergoing elective cardiac surgery, aged between 5 to 15 years will be included in this study along with their parents.

排除标准

  • •emergency surgery, redo surgery, off pump cardiac surgeries, preoperative diagnosed psychiatric illness, patients with hearing and vision defects.

结局指标

主要结局

1. Effect of video, games and toys on relieving stress, anxiety, pain and improving mood in children undergoing cardiac surgery.

时间窗: Five days before surgery to one month after surgery

2. Effect of information, education and counselling on stress and anxiety of children and parents

时间窗: Five days before surgery to one month after surgery

次要结局

  • 1. Incidence of stress and anxiety in parents and children undergoing cardiac surgery(2. Risk factors associated with stress and anxiety in parents and children undergoing cardiac surgery)

研究者

申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验