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Is to easy to separate the child from the mother before operation by giving a small small pill to the mother

Does reduction of anxiety in mother ease the separation of the child in the preoperative area A double-blind randomized trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/098024
Enrollment
90
Registered
2025-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: Z048- Encounter for examination and observation for other specified reasons

Interventions

Intervention1: tablet and anxiolysis: tablet diazepam 5 mg oral for the mother two hours prior to possible separation Control Intervention1: placebo: tablet placebo oral for the mother two hours prio

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: to the mother of babies Inclusion Criteria: Participants: Mothers of children aged 2 to 6 years who are scheduled for elective surgeries requiring general anesthesia. Children who can be safely cared for in the preoperative setting without any major medical contraindications. Health Status: Children classified as ASA (American Society of Anesthesiologists) physical status I (normal healthy child) or II (mild systemic disease). Consent: Written informed consent provided by the mother/guardian for participation in the study.

Exclusion criteria

Exclusion criteria: anxiety disorders in mother major emergency procedures for the baby not giving consent

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of pharmacological reduction of parental anxiety compared with placebo, effectively reduces anxiety levels in children in the preoperative period.Timepoint: At the time of taking the child patient to theatre with separation from mother only one time point in the study

Secondary

MeasureTime frame
any side effect for the motherTimepoint: for six hours after administration

Countries

India

Contacts

Public ContactS Parthasarathy

ST multispecialty hospitals (private) ltd, kumbakonam - Tamilnadu, India

anaespartha@gmail.com09344304042

Outcome results

None listed

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