CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/07/092108 [Registered on: 31/07/2025] Trial Registered Prospectively

Last Modified On:

31/07/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Preventive
Screening
Other (Specify) [Counselling]

Study Design

Other

Public Title of Study

Counselling for mothers of neonates admitted in NICU’s across the state of Goa who are having anxiety and depressive symptoms.

Scientific Title of Study

Impact of structured counselling program on anxiety and depressive symptoms among mothers of neonates admitted in NICU’s across the state of Goa.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Sanjita Naik
Designation	Tutor
Affiliation	Institute of Nursing Education, Bambolim-Goa.
Address	Bambolim, Goa Bambolim-Goa. North Goa GOA 403001 India
Phone	7387455912
Fax
Email	sanjitanaik2911@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. VeereshKumar Nandagaon
Designation	Principal
Affiliation	KAHER Institute of Nursing Sciences
Address	KAHER Institute of Nursing Sciences, Belagavi, Karnataka. Belagavi, Karnataka Belgaum KARNATAKA 590010 India
Phone	9844971345
Fax
Email	veereshnandagaon@yahoo.co.in

Details of Contact Person
Public Query

Name	Dr. Wilson Fernandes
Designation	Principal
Affiliation	Institute of Nursing Education, Bambolim-Goa.
Address	Institute of Nursing Education Bmbolim-Goa Bambolim-Goa. Pin:403001 North Goa GOA 403001 India
Phone	9552386303
Fax
Email	wilsonphdgudms@yahoo.co.in

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Sanjita Naik
Address	Institute of Nursing Education, Bambolim-Goa,India 403001
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Wilson Fernandes	Goa Medical College & Hospitals, Royal, Classic, Healthway & Gauns Hospital	NICU setting of Goa Medical College & Hospitals, Royal, Classic, Healthway & Gauns Hospital North Goa GOA	9552386303 wilsonphdgudms@yahoo.co.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
KAHER Ethical Committee (Human)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Mothers of neonates (postpartum stage)

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Routine Care Provision	Screening of anxiety and depressive symptoms by using an anxiety and depressive rating scale. participants in the control group will receive routine care from the NICU staff
Intervention	Structured Counselling Program	Participants in the intervention group will be screened for anxiety and depressive symptoms and shall receive five individual counselling sessions, each lasting 15–20 minutes, conducted over five consecutive days. The sessions will focus on emotional support, stress management, and coping strategies to reduce anxiety and depressive symptoms. Post-intervention assessment will be conducted using the same standardized tools used at baseline. If symptoms persist, additional sessions, tele-counselling, or home visits will be arranged based on the mothers condition and accessibility.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Female
Details	Mothers of neonates admitted in NICU for more than 48 hours. Mothers who are able to understand and communicate in English, Konkani, Marathi or Hindi. Mothers who are willing to participate or provide informed consent

ExclusionCriteria

Details

Mothers who have pre-diagnosed mental health related disorders.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Alternation

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
Mothers who receive counselling will report better emotional adjustment, improved coping mechanisms, and enhanced psychological resilience during their child’s NICU stay.	After 1 week of counselling

Secondary Outcome

Outcome	TimePoints
The counselling intervention will lead to a statistically significant reduction in both depressive & anxiety symptoms among the mothers in the experimental group compared to the control group.	after 1 week

Target Sample Size

Total Sample Size="160"
Sample Size from India="160"
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)

15/01/2026

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

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

Primary purpose

The primary purpose of this study protocol is to evaluate the effectiveness of a structured counselling program in reducing depressive and anxiety symptoms among mothers of neonates admitted to Neonatal Intensive Care Units (NICUs). The intervention is designed to provide emotional support, improve psychological resilience, and promote mental well-being during a period of high stress and vulnerability.

Study Hypothesis

The study hypothesizes that mothers who receive the structured counselling program will exhibit a significant reduction in depressive and anxiety symptoms compared to those who do not receive the intervention.