Role of distracters (pacifiers and human care contact) as pain relief measures during clubfoot casting.

To compare the efficacy of two non-pharmaceutical (non-nutritive sucking and human care contact) pain relief measures for clubfoot casting using Ponseti technique: A randomized control study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/06/034017

Enrollment

Registered

2021-06-07

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: M215- Acquired clawhand, clubhand, clawfoot and clubfoot

Interventions

Intervention1: Non-nutritive sucking group: A standard silicone pacifier will be provided to the infant during the period of casting. Intervention2: Human care contact group.: infant will be placed in

Eligibility

Inclusion criteria

Inclusion criteria: 1.Unilateral and bilateral idiopathic clubfoot children between 15 days to 6 months.

Exclusion criteria

Exclusion criteria: 1.Surgically intervened/ operated clubfeet 2.Complex/ atypical clubfeet 3.Sucking problems due to any other medical/surgical reasons 4.Have been given analgesic within 6 hours of data collection

Design outcomes

Primary

Measure	Time frame
Ã¢â?¬Â¢To calculate Pain score using Neonatal infant pain score (NIPS) during casting at each sessionTimepoint: At 1 min before the procedure, during casting and at 1 min after the procedure.	—

Secondary

Measure	Time frame
Ã¢â?¬Â¢To compare heart rate during casting in various groups. To compare heart rate variation in each groupTimepoint: At 1 min before the procedure, during the casting and at 1 min after the procedure.	—

Countries

India

Contacts

Public ContactAnkur

Chacha Nehru Bal Chikitsalaya, Geeta Colony, New Delhi

anilrachna@gmail.com8595919304

Outcome results

None listed

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