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Effect of Non-pharmacological Interventions with Heel Warming on Pain During Heel Prick in Preterm Babies

Efficacy and Safety of Occupational Therapy-Based Non-Pharmacological Interventions Combined with Heel Warming for Reducing Pain during Heel Lance in Preterm Neonates - NIL

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101573
Enrollment
200
Registered
2026-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Group 1: Swaddling and heel warming: Swaddling will be performed 5 minutes before the heel lance and maintained throughout the procedure. The lower end of the swaddle will be unfolded t

Sponsors

Tamil M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Clinically stable preterm neonates with gestational age 30 to 36 weeks Fed and calm 1 to 2 hours before the procedure

Exclusion criteria

Exclusion criteria: Congenital anomalies affecting feeding or neurological status Received analgesics or sedatives within the last 6 hours Suspected coagulation disorder or severe illness Receiving oxygen therapy and mechanical ventilation

Design outcomes

Primary

MeasureTime frame
Reduction in procedural pain intensity during heel lance in preterm neonates, measured using a validated neonatal pain assessment scale (e.g., PIPP-R Before during and immediately after the procedure.Timepoint: Before during and immediately after the procedure.

Secondary

MeasureTime frame
Changes in heart rate and oxygen saturation, behavioral pain responses, and comparison of pain scores across intervention groupsTimepoint: Before during and immediately after the procedure.

Countries

India

Contacts

Public ContactProf Raghuram P

Sri Ramachandra Faculty of Occupational Therapy,SRIHER(DU)

raghurammot@sriramachandra.edu.in9677073853

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026