| CTRI Number |
CTRI/2024/07/071715 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Anxiety and Sleep Disruption in mothers of babies in NICU |
|
Scientific Title of Study
|
To Assess the prevalence and Risk factors of Anxiety and Sleep Disruption in Mothers of critically ill Neonates admitted to Neonatal Intensive Care Unit. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amaldev Vasudevan Pillai |
| Designation |
Medical Student |
| Affiliation |
Government Medical College and Hospital Aurangabad |
| Address |
Department of Neonatology,Government Medical College and Hospital Aurangabad ,Panchakki Road Aurangabad 431001
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9373469807 |
| Fax |
|
| Email |
amaldev15601@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Atul Londhe |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital Aurangabad |
| Address |
Department of Neonatology,Government Medical College and Hospital Aurangabad ,Panchakki Road Aurangabad 431001
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
8275453997 |
| Fax |
|
| Email |
atul.londhe1982@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amaldev Vasudevan Pillai |
| Designation |
Medical Student |
| Affiliation |
Government Medical College and Hospital Aurangabad |
| Address |
Department of Neonatology,Government Medical College and Hospital Aurangabad ,Panchakki Road Aurangabad 431001
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9373469807 |
| Fax |
|
| Email |
amaldev15601@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neonatology, Government Medical College and Hospital Aurangabad.
Address-University Road, Jubilee Park,Aurangabad,Maharashtra-431001 |
|
|
Primary Sponsor
|
| Name |
Amaldev Vasudevan Pillai |
| Address |
Hameed Residency, Flat No.6,Second Floor, Near Makai Gate, Navkhanda,Aurangabad-431001 |
| Type of Sponsor |
Other [Borne by the Principal Investigator] |
|
|
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 |
| DrAtul Londhe |
Department of Neonatology ,Government Medical College and Hospital Aurangabad |
University Road, Jubilee Park, Aurangabad,Maharashtra-431001
Aurangabad
MAHARASHTRA |
8275453997
atul.londhe1982@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC-GMCA)GOVT.MEDICAL COLLEGE AURANGABAD-431001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, (2) ICD-10 Condition: F510||Insomnia not due to a substance orknown physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIl |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
17.00 Day(s) |
| Age To |
39.00 Day(s) |
| Gender |
Female |
| Details |
Mothers of Critically ill Neonates admitted in NICU during the period of study, who have visited the NICU for atleast 4 days; are approached for the study within 10 days of the admission of their neonate. |
|
| ExclusionCriteria |
| Details |
1)Mothers who are not willing to participate in the study.
2)Mothers of Neonates admitted to NICU who already have been diagnosed with Anxiety and Insomnia before the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Anxiety and Sleep Disturbance |
within 10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relationship of Age ,parity, previous NICU experiences, socioeconomic status on development of anxiety and sleep disruption. |
within 10 days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
25/09/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This Prospective Observational Cross Sectional study assesses the prevalence and risk factors of anxiety and sleep disruption in mothers of critically ill neonates admitted to Neonatal Intensive Care Unit in Government Medical College Aurangabad. The study participants are 200 mothers of critically ill neonates admitted to NICU who have visited the NICU for atleast 4 days are approached for the study within 10 days of the admission of their neonate. Standardized PROMIS (Patient Reported Outcomes Measurement System) Questionnaire are utilized for categorizing the anxiety and sleep disturbance in mothers as mild ,moderate and severe based on the T scores obtained using these questionnaire. Mothers who are already diagnosed cases of anxiety and insomnia and who do not wish to participate in the study are excluded from the study. The influence of age and parity of mother ,socioeconomic background and past NICU experiences of mother in the development of anxiety and sleep disturbances will also be studied. The influence of healthcare staff communication regarding the condition of the neonate and about maternal adaptation in NICU in the development of anxiety and sleep disruption will also be studied.
|