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Measuring Pregnancy Loss Trauma among women through a newly developed scale and reducing mental health impacts of pregnancy loss through Psychological Intervention

Psychosocial Dynamics of Pregnancy Loss: Development of a Multidimensional Scale & Development and Efficacy (a Randomized Control Trial) of a Group Psychological Intervention Module

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041342
Enrollment
100
Registered
2022-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O038- Other and unspecified complications following complete or unspecified spontaneous abortion

Interventions

Intervention1: Group-Administered Psychosocial intervention for Pregnancy Loss Experience (GRAPPLE).: This intervention module has a total of six sub-modules namely, Psychoeducation-Total Health Post-
Stress and Anxiety Management
Interpersonal Relationship and Effective Communication
Mind-Body Focused Self-Management
Pregnancy Loss Trauma, Grief, and Social Support Skills
Help-seeking Behaviour, and Resilience. And each sub-module has many small topics to be delivered to the women in an activity-oriented and audio-visual material-based group intervention format. Contro

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) To develop a multidimensional scale to measure psychological trauma and its correlates associated with pregnancy loss (PL) and to establish the psychometric properties of this newly developed scale 2) To develop and test the feasibility of a group psychological intervention module 3) To conduct a Randomized Controlled Trial on the efficacy of newly developed group psychological intervention module on PL

Exclusion criteria

Exclusion criteria: Exclusion criteria • Women who voluntarily opt for MTP • Women treated for primary and secondary infertility • Women having diagnosed psychiatric illness • Women who can not participate due to health condition (bed rest, or co-morbid physical health condition, etc)

Design outcomes

Primary

MeasureTime frame
1. To develop a multidimensional scale to measure psychological trauma and its correlates associated with pregnancy loss (PL) and to establish the psychometric properties of this newly developed scale 2. To develop and test the feasibility of a group psychological intervention module 3. To conduct a Randomized Controlled Trial on the efficacy of newly developed group psychological intervention module on PL Timepoint: Base line and 4 weeks follow up

Secondary

MeasureTime frame
No secondary outcomesTimepoint: 2

Countries

India

Contacts

Public ContactSujata Satapathy

Department of Psychiatry, AIIMS, New Delhi

dr.sujatasatapathy@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026