CTRI Number |
CTRI/2019/01/017058 [Registered on: 14/01/2019] Trial Registered Prospectively |
Last Modified On: |
07/08/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Parental Anxiety in children undergoing surgery a question based study. |
Scientific Title of Study
|
Parental Anxiety in children undergoing surgery, an observational study |
Trial Acronym |
PAICS Study |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Alok Kumar Sahoo |
Designation |
Assistant Professor |
Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE |
Address |
Room no 508, I block, 5th Floor, Sijua, AIIMS
Khordha ORISSA 751019 India |
Phone |
09438884160 |
Fax |
|
Email |
alokks108@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Alok Kumar Sahoo |
Designation |
Assistant Professor |
Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE |
Address |
Department of Anaesthesiology, Room No 508,Sijua, AIIMS
Khordha ORISSA 751019 India |
Phone |
09438884160 |
Fax |
|
Email |
alokks108@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Alok Kumar Sahoo |
Designation |
Assistant Professor |
Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE |
Address |
Department of Anaesthesiology, Room No 508,Sijua, AIIMS
Khordha ORISSA 751019 India |
Phone |
09438884160 |
Fax |
|
Email |
alokks108@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology,Sijua, AIIMS, Bhubaneswar |
|
Primary Sponsor
|
Name |
AIIMS Bhubaneswar |
Address |
Sijua, Bhubaneswar |
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 |
alok kumar sahoo |
AIIMS |
Department of Anaesthesiology, Room No 508,Sijua, AIIMS Khordha ORISSA |
9438884160
alokks108@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 3 |
Name of Committee |
Approval Status |
institutional ethics committee |
Approved |
institutional ethics committee |
Approved |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
parents of the child undergoing surgery |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
All the parents whose children undergoing elective surgery. |
|
ExclusionCriteria |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
Prevalence of preoperative anxiety among parents whose child is undergoing surgery. |
preoperative 24hr period |
|
Secondary Outcome
Modification(s)
|
Outcome |
TimePoints |
1- To measure the education status of parents & its relation with the level of
anxiety.
2- to measure socioeconomic status of parents & its relation with the level of anxiety.
3- to see the association of preop & postop anxiety WITH
-duration, magnitude of surgery
-sex, age & number of children.
-waiting time for surgery & order of surgery
|
perioperative period till 3 days or discharge |
|
Target Sample Size
Modification(s)
|
Total Sample Size="216" Sample Size from India="216"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
14/01/2019 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
not published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Surgery and Hospitalisation of a child and has a very stressful consequence for the child and their parents. Perioperative anxiety is a common phenomenon and it starts from the admission till child get discharged cured. [2,3]. Various literature described a high level of parental anxiety in the child’s preoperative period. Mothers are more prone to experience anxiety before their child’s surgery than fathers are and divorced parents and parents with lower educational levels rate themselves as significantly more anxious preoperatively. The parental anxiety usually transferred to the child, which leads to the stressful and very anxious child before surgery. 4 Increased preoperative anxiety in children has been shown to correlate with increased postoperative pain, analgesic requirements and long-lasting psychological effects on the child’s response to subsequent medical care and interference with normal development .4
Education plays important role in controlling anxiety with low education level was significantly associated with anxiety and depression.5 Furthermore, some study also shows that Parental anxiety levels did not correlate with civil or educational status 4.
Cultural and ethnic background influences the anxiety of parents and children. Apart from this, there are almost negligible Indian data or studies available about the parental anxiety in preop area.
Hence, we plan this study to identify the prevalence of level of anxiety in parents of children who will undergo various surgeries and their relationship with the education level, financial status of parent, age & sex of the child in the preoperative area. |