Comparison of parental presence and absence on anxiety level and its correlation with stress bio-markers during initiation of anesthesia in children undergoing ophthalmic procedures.
- Conditions
- Diseases of the eye and adnexa,
- Registration Number
- CTRI/2020/02/023492
- Lead Sponsor
- AIIMS Delhi
- Brief Summary
Preoperative anxiety in children is a significant and challenging problem. Although all children are vulnerable, preschool children and toddlers 1 to 6 years seem to be most vulnerable [1]. Studies have demonstrated an association between preoperative anxiety and adverse postoperative clinical outcomes, such as emergence delirium, increased analgesic requirements, and negative behavioural changes (e.g. bed-wetting, altered appetite, sleep disturbance and separation anxiety) [1-3].In order to diminish the anxiety during induction period, some methods have been studied before, including parental presence and premedication. However, a consensus has not been obtained in the literature about this issue. Parental presence is suggested to decrease level of anxiety of the children during induction period. However some studies have shown the conflicting results due to anxious parents unable to support their child during induction.ED was first described in 1960s with the incidence varies from 2% to 80%[4].Primary Objective-Effect on child’s anxiety scores with and without parental presence during induction of anaesthesia,Secondary Objectives-Effect of Parental presence on stress biomarkers(cortisol, Chromogranin, and melatonin ) during induction of anaesthesia with and without parental presence during induction of anaesthesia,Effect of parental presence on the incidence of emergence delirium,Parental anxiety score and to correlate the serum levels of cortisol, Chromogranin, and melatonin with salivary levels in presence and absence of parent during induction of anaesthesia.Study design-Prospective randomised controlled trial **Sample size** - Estimated mean (SD) of anxiety score after induction of general anaesthesia was 59.8. We hypothesize that 20% reduction in anxiety score l will be clinically significant. To detect 20% reduction in anxiety score with 80% power and alpha of 0.05, at least 44 children will be required in each group. Hence, n=88 children will be recruited in this study.Anesthesiologist who are not an investigator of the study will collect all outcome dataand will be tabulated in Microsoft excel data sheet and analyzed by SPSS software.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 88
1.Children between the age group of 5 years to 12 years for ophthalmic procedures 2.ASA I and II.
(a)Suspected difficult airway (b)Severe and significant congenital heart disease (c)Bleeding diathesis (d)Parental refusal (e)History of sleep apnea (f)Children with any neurological or psychological disorders (g)Chronic systemic diseases (h)History of previous surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect on child’s anxiety scores with and without parental presence during induction of anaesthesia At baseline,At induction of anaesthesia(Zero min of procedure)
- Secondary Outcome Measures
Name Time Method 1.Effect of Parental presence on stress biomarkers(cortisol, Chromogranin, and melatonin ) during induction of anaesthesia with and without parental presence during induction of anaesthesia 2.Effect of parental presence on the incidence of emergence delirium
Trial Locations
- Locations (1)
Dr Rajendra Prasad center for ophthalmic sciences AIIMS, New Delhi
🇮🇳South, DELHI, India
Dr Rajendra Prasad center for ophthalmic sciences AIIMS, New Delhi🇮🇳South, DELHI, IndiaDr Nishant PatelPrincipal investigator01126493212pateldrnishant@gmail.com