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To evaluate the effectiveness of structured counselling before a Pap smear in reducing anxiety among women at a tertiary care hospital in Northern India

Effect of pre procedural structured counselling on anxiety levels among women undergoing Pap smear at a tertiary care facility in northern india: A randomised controlled trial - OPEN LABEL . - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108726
Enrollment
140
Registered
2026-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

None listed

Interventions

Intervention1: Counselling Group: Impact of Structured Counselling Delivered before and after Pap smear in Alleviating Anxiety . Participant in this group will recieve 10-15 minutes of structured co

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: i)Women aged 25 to 60 years attending gynaecology OPD for routine cervical cancer screen at AIIMS Patna. ii)Willing to undergo pap smear iii)Able to understand and respond the anxiety assessment tool(CDDQ) in local language or english.

Exclusion criteria

Exclusion criteria: i)History of psychiatric illness or currently using anxiolytic and anti depressant medications. ii)Known case of cervical cancer or undergone hysterectomy. iii)Women undergoing pap smear as a part of post treatment surveillance or women unwilling or unable to participate.

Design outcomes

Primary

MeasureTime frame
Change in anxiety score measured using Cervical Dysplasia Distress Questionnaire (CDDQ). Anxiety levels will be assessed at two time points: Baseline (before Pap smear procedure) 20 30 minutes after completion of Pap smear The primary outcome will be the difference in mean anxiety score (pre- and post-procedure) within and between the intervention and control groups. Timepoint: From baseline to 20 30 minutes post-procedure (same day).

Secondary

MeasureTime frame
Participant satisfaction regarding Pap smear procedure. Assessed using a structured Likert scale based satisfaction questionnaire administered 20 30 minutes after the procedure. Time Frame: 20 30 minutes post-procedure (same day). Perceived usefulness of structured counselling (Intervention group only). Assessed using a structured questionnaire evaluating reassurance, clarity of information, & overall helpfulness of counselling. Timepoint: 20 30 minutes post-procedure (same day).

Countries

India

Contacts

Public ContactDr Anita Paswan

AIIMS Patna

dranitapaswan@aiimspatna.org9871091838

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026