Leg and Foot Massage for Pain in Newborns Receiving Heel Stick

NCT07893028 | Not Yet Recruiting

• 1 other identifier: 016/2569
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of a leg and foot massage program on pain in newborns receiving heel stick for monitoring serum bilirubin levels. Newborns will be assigned to either a leg and foot massage group or a control group. Pain will be assessed during the heel stick procedure using a neonatal pain assessment tool. The study will determine whether leg and foot massage can reduce pain associated with heel stick in newborns.

Conditions

Procedural Pain in Newborns

Keywords

neonatal pain; Heel Prick; Heel Stick; Leg and foot massage; Newborn

Outcome Measures

Primary Outcomes (1)

• Neonatal pain assessed using the Neonatal Infant Pain Scale (NIPS)

  Neonatal pain is assessed using the Neonatal Infant Pain Scale (NIPS), which evaluates six indicators: facial expression, cry, breathing pattern, arms, legs, and state of arousal. Higher scores indicate greater pain.

  During heel stick and at 1, 3, and 5 minutes after heel stick.

Study Arms (2)

Leg and Foot Massage Group

EXPERIMENTAL

Newborns receive a standardized leg and foot massage before heel stick for monitoring serum bilirubin levels.

Behavioral: Leg and Foot Massage

Control Group

NO INTERVENTION

Newborns receive routine care without leg and foot massage before heel stick for monitoring serum bilirubin levels.

Interventions

Leg and Foot Massage BEHAVIORAL

A standardized leg and foot massage is administered to newborns before heel stick for monitoring serum bilirubin levels. The massage is performed according to the specified massage protocol.

Leg and Foot Massage Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Term newborns with a gestational age of 37-42 weeks and a birth weight of 2,500-4,000 grams, receiving their first heel stick for monitoring serum bilirubin levels.
• Normal vital signs.
• The parent provides consent for participation in the study.

You may not qualify if:

• Newborns diagnosed with neurological disorders or congenital abnormalities that may affect pain perception, such as intracranial hemorrhage or seizures.
• Abnormalities of the muscles, bones, or legs that prevent leg and foot massage.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Somdej Phra Borom Ratchathewi at Si Racha Hospital, Thai Red Cross Society

Si Racha, Changwat Chon Buri, 20110, Thailand

Location

Study Officials

• Chollada Jongsomjitt, PhD, RN

  Faculty of Nursing, Chulalongkorn University

  STUDY CHAIR

Central Study Contacts

Thamonwan Ruangsrivoraporn, BNS, RN

CONTACT

+66 624966529; 6770031836@student.chula.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor was blinded to group assignment and assessed neonatal pain from video recordings using the Neonatal Infant Pain Scale (NIPS). The assessor was not involved in the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): October 26, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)