| CTRI Number |
CTRI/2020/02/023492 [Registered on: 21/02/2020] Trial Registered Prospectively |
| Last Modified On: |
20/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
Comparison of Anxiety scores with or without parental presence and its correlation with stress biomarkers during induction of anaesthesia in children undergoing ophthalmic procedures-A Randomised controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nishant Patel |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS ,New Delhi |
| Address |
Room No. 5011,Teaching Block Department of Anesthesiology,Pain medicine and Critical care
AIIMS, New Delhi
Room No. 5011,Teaching Block Department of Anesthesiology,Pain medicine and Critical care
AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
01126493212 |
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishant Patel |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS ,New Delhi |
| Address |
Room No. 5011,Teaching Block Department of Anesthesiology,Pain medicine and Critical care
AIIMS, New Delhi
Room No. 5011,Teaching Block Department of Anesthesiology,Pain medicine and Critical care
AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
01126493212 |
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishant Patel |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS ,New Delhi |
| Address |
Room No. 5011,Teaching Block Department of Anesthesiology,Pain medicine and Critical care
AIIMS, New Delhi
Room No. 5011,Teaching Block Department of Anesthesiology,Pain medicine and Critical care
AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
01126493212 |
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Delhi |
| Address |
Room No. 5011,Teaching block,Department Of Anesthesiology,Pain Medicine and Critical care, AIIMS New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nishant Patel |
Dr Rajendra Prasad center for ophthalmic sciences AIIMS, New Delhi |
Room No. 5011, Teaching Block,Department of Anaesthesiology , Pain medicine and Critical Care,Aiims, New delhi
South
DELHI |
01126493212
pateldrnishant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of Anxiety scores with or without parental presence and its correlation with stress biomarkers during induction of anaesthesia in children undergoing ophthalmic procedures |
Comparison of Anxiety scores with or without parental presence and its correlation with stress biomarkers during induction of anaesthesia in children undergoing ophthalmic procedures |
| Comparator Agent |
Group N-The children in Group “N†will be separated from their parent at the preoperative waiting area and shifted to OR by anaesthesia resident |
After detailed pre anaesthetic check-up and relevant investigations, an informed consent will be taken from the parents and assent from children more than 7 years. Anxiety score of the parent and the child will also be noted in the waiting area by state trait anxiety inventory (STAI) and Modified Yale Preoperative Anxiety Scale respectively.
Salivary and blood samples will be collected in pre-operative waiting area in morning for baseline markers in all children in parental presence. Blood sample will be collected while securing the intravenous cannula to avoid additional invasive intervention.
Randomisation of the children would be done using computer generated instructions on the day of procedure.The children in group “N†will be separated from their parent at the preoperative waiting area and shifted to OR by anaesthesia resident.In the OR, child will be given toy to hold, the standard monitors [electrocardiograph (ECG), pulse oximeter (SpO2), non-invasive blood pressure (NIBP) end tidal carbon dioxide (EtCO2)] would be attached and baseline heart rate (HR) and blood pressure (systolic, diastolic and mean) will be noted. Anxiety will be measured by Modified Yale Preoperative Anxiety Scale on the operating table after placing mask over face of children.Anaesthesia will be induced with sevoflurane, oxygen and air.After induction, blood and salivary sample of the child will be again collected.Parent anxiety score will be noted by state trait anxiety inventory (STAI).Airway will be secured with appropriate size supraglottic airway device (SGAD).
|
| Comparator Agent |
Group P-Children in group “P†will stay with their parent from pre-operative waiting area to operating room (OR) |
After detailed pre anaesthetic check-up and relevant investigations, an informed consent will be taken from the parents and assent from children more than 7 years. Anxiety score of the parent and the child will also be noted in the waiting area by state trait anxiety inventory (STAI) and Modified Yale Preoperative Anxiety Scale respectively.
Salivary and blood samples will be collected in pre-operative waiting area in morning for baseline markers in all children in parental presence. Blood sample will be collected while securing the intravenous cannula to avoid additional invasive intervention.
Randomisation of the children would be done using computer generated instructions on the day of procedure.Children in group “P†will stay with their parent from pre-operative waiting area to operating room (OR).
In the OR, child will be given toy to hold, the standard monitors [electrocardiograph (ECG), pulse oximeter (SpO2), non-invasive blood pressure (NIBP) end tidal carbon dioxide (EtCO2)] would be attached and baseline heart rate (HR) and blood pressure (systolic, diastolic and mean) will be noted. Anxiety will be measured by Modified Yale Preoperative Anxiety Scale on the operating table after placing mask over face of children.
Anaesthesia will be induced with sevoflurane, oxygen and air. After induction parent will be accompanied to waiting area and anxiety score will be noted by state trait anxiety inventory (STAI). After induction, blood and salivary sample of the child will be again collected.
Airway will be secured with appropriate size supraglottic airway device (SGAD) |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children between the age group of 5 years to 12 years for ophthalmic procedures
2.ASA I and II
|
|
| ExclusionCriteria |
| Details |
(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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
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
3.Parental anxiety score
4.To correlate the serum levels of cortisol, Chromogranin, and melatonin with salivary levels in presence and absence of parent during induction of anaesthesia
|
Baseline,At induction, After Procedure 0 min,5min,10min and 20 min. |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
31. Kain ZN, Wang SM, Mayes LC et al - Distress during the induction of anesthesia and postoperative behavioral outcomes. AnesthAnalg, 1999;88:1042-1047. [ Links ]
32. Schwartz BH, Albino JE, Tedesco LA - Effects of psychological preparation on children hospitalized for dental operations. J Pediatr 1983;102:634-638. [ Links ]
33. Meyers E, Muravchick S - Anesthesia induction technics in pediatric patients: a controlled study of behavioral consequences. AnesthAnalg, 1977;56:538-542.
34. Afsaneh Sadeghi et al Impact of parental presence during induction of anesthesia on anxiety level among pediatric patients and their parents: a randomized clinical trial Neuropsychiatric Disease and Treatment 2016:12
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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. |