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Comparison of Group and Individual Discussion in Understanding Consent to Participate in Research

Efficacy of Group Counseling in the Comprehension of Informed Consent as Compared to Individual Counseling: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000612
Enrollment
128
Registered
2009-08-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Group counseling: Information about the study will be provided in form of focus group discussions, with study nurses acting as facilitators. Thereafter, individual consent will be obtai

Sponsors

Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Parents of malnourished children participating in a trial of nutritional supplementation in pre-schools (balwadis) run by the Community Health & Development (CHAD), Christian Medical College, Vellore, INDIA Permanent residents of Kaniyambadi block, Vellore district, Tamil Nadu, INDIA

Exclusion criteria

Exclusion criteria: Not a permanent resident of the study area Not studying in a CHAD pre-school (balwadi)

Design outcomes

Primary

MeasureTime frame
Comprehension of informed consentTimepoint: 48-72 hours after administration of informed consent—

Secondary

MeasureTime frame
NilTimepoint: Nil—

Countries

India

Contacts

Public ContactRajiv Sarkar

Christian Medical College, Vellore

rsarkar@cmcvellore.ac.in04162282052

Outcome results

None listed

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