ClinicalTrials.gg
Not yet recruitingNCT07893028Updated Oct 23, 2026

Leg and Foot Massage for Pain in Newborns Receiving Heel Stick

An interventional study of Leg and Foot Massage in Procedural Pain in Newborns, sponsored by Chulalongkorn University. Not yet recruiting at 1 site in Thailand. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Treatment

Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Procedural Pain in Newborns

Keywords

  • neonatal pain
  • Heel Prick
  • Heel Stick
  • Leg and foot massage
  • Newborn
03

In context

Lead sponsor

Chulalongkorn University is the lead sponsor of 320 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Leg and Foot Massage Group

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

    Behavioral: Leg and Foot Massage

  • No intervention
    Control Group

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

Interventions

  • BehavioralLeg and Foot Massage

    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.

06

What researchers measure

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.

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

07

Study locations

1 site
  • Somdej Phra Borom Ratchathewi at Si Racha Hospital, Thai Red Cross Society
    Si Racha, Changwat Chon Buri 20110, Thailand
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared with other researchers because the study data are collected for the purpose of this research and are not intended for individual-level data sharing.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07893028
Responsible party
Sponsor
First posted
Oct 23, 2026
Start date
Oct 26, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 23, 2026

Study contacts

Thamonwan Ruangsrivoraporn, BNS, RN
Contact
6770031836@student.chula.ac.th
+66 624966529
Chollada Jongsomjitt, PhD, RN
study chair · Faculty of Nursing, Chulalongkorn University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion