Perioperative anxiety and stress in children and parents undergoing congenital cardiac surgery: Effect of brief intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1. Effect of video, games and toys on relieving stress, anxiety, pain and improving mood in children undergoing cardiac surgery.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 5.00 Year(s) to 15.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
1. Effect of video, games and toys on relieving stress, anxiety, pain and improving mood in children undergoing cardiac surgery.
Time Frame: Five days before surgery to one month after surgery
2. Effect of information, education and counselling on stress and anxiety of children and parents
Time Frame: Five days before surgery to one month after surgery
Secondary Outcomes
- 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)