| CTRI Number |
CTRI/2024/01/061522 [Registered on: 16/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Does a multicomponent Program to Prepare Parents, Affects Their Anxiety Before and After Surgery- A Randomised Controlled Trial |
|
Scientific Title of Study
|
The Effect of an Integrated Parental Prepration Program on the Perioperative Parental Anxiety - A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Darshana Rathod |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Jodhpur |
| Address |
Department of Anaesthesiolgy and Critical Care, All India Institute of Medical Sciences (AIIMS), HI Area, phase II, Basni, Jodhpur, Rajasthan, 342005, India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8769135511 |
| Fax |
|
| Email |
d27rathod@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Darshana Rathod |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Jodhpur |
| Address |
Department of Anaesthesiolgy and Critical Care, All India Institute of Medical Sciences (AIIMS), HI Area, phase II, Basni, Jodhpur, Rajasthan, 342005, India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8769135511 |
| Fax |
|
| Email |
d27rathod@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhijeet |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Jodhpur |
| Address |
Department of Anaesthesiolgy and Critical Care, All India Institute of Medical Sciences (AIIMS), HI Area, phase II, Basni, Jodhpur, Rajasthan, 342005, India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9739501763 |
| Fax |
|
| Email |
me.abhijeet@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, Jodhpur |
| Address |
Department of Anaesthesiolgy and Critical Care, All India Institute of Medical Sciences (AIIMS), HI Area, phase II, Basni, Jodhpur, Rajasthan, 342005, India |
| 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 Darshana Rathod |
AIIMS, Jodhpur |
Department of Anaesthesiolgy and Critical Care, All India Institute of Medical Sciences (AIIMS), HI Area, phase II, Basni, Jodhpur, Rajasthan, 342005, India
Jodhpur
RAJASTHAN |
8769135511
d27rathod@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy parents |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Prepration program |
The integrated preparation program includes comprehensive information and education (audio-visual), psychological support, deep breathing exercises. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Parents of pediatric patients aged 2 to 12 years, undergoing elective surgery |
|
| ExclusionCriteria |
| Details |
Parents of children with a history of chronic illness, prematurity, diagnosed with developmental delay, parents with known psychiatric and anxiety disorders, parental noncompliance to the intervention |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of an integrated preparation program in reducing parental anxiety in the perioperative period |
Perioperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To identify factors causing parental burden in the perioperative period.
2. To study the association of factors causing burden with perioperative parental anxiety.
3. To study the correlation of preoperative parental anxiety with anxiety in the child.
4. Correlation of parental anxiety with child’s pain scores, emergence delirium, and discharge time from post-anaesthesia care unit.
5. Parent satisfaction |
Perioperative period |
|
|
Target Sample Size
|
Total Sample Size="172"
Sample Size from India="172"
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)
|
01/02/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Recent studies have highlighted that 40-70% of parents and 50-70% of children experience preoperative anxiety attributed to various factors. Nonpharmacological interventions remain the mainstay of management modalities. Most studies have highlighted preoperative anxiety, while few have studied postoperative anxiety in parents. To best of our knowledge, the intraoperative period is not studied so far. We believe that, when an intervention covers the perioperative period (preop, intraop, postop), it can be more efficient in dealing with parental anxiety. Various challenges faced by patients/parents. The questionnaire will help find specific factors causing burden which may contribute to anxiety. The parents at high risk of developing anxiety during the perioperative period can be identified, and such parents can get targeted intervention from the preoperative period.
The integrated preparation program could be an effective intervention therapy in reducing perioperative anxiety in parents of children undergoing elective surgeries. |