Measuring Anxiety and Stress before and after heart surgery undergoing children and their parents

Recruiting

• Conditions: Children with cardiac disease undergoing surgery and their parents

• Registration Number: CTRI/2017/10/009980
• Lead Sponsor: All India Institute Of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-11
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Effect of video, games and toys on relieving stress, anxiety, pain and improving mood in children undergoing cardiac surgery.	Five days before surgery to one month after surgery
2. Effect of information, education and counselling on stress and anxiety of children and parents	Five days before surgery to one month after surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

All India Institute Of Medical Sciences(AIIMS); 🇮🇳 Delhi, DELHI, India

All India Institute Of Medical Sciences(AIIMS)

🇮🇳Delhi, DELHI, India

K Ashok Kumar

Principal investigator

8860121602

ashok.medickaramsi@gmail.com