Procedural Pain in NewbornsNCT07893028
Leg and Foot Massage for Pain in Newborns Receiving Heel Stick
A study testing Leg and Foot Massage in people with Procedural Pain in Newborns, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Procedural Pain in Newborns
- What is being tested?
- Leg and Foot Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteThailand
- Study dates
- 26 Oct 2026to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Somdej Phra Borom Ratchathewi at Si Racha Hospital, Thai Red Cross Society
Si Racha, Changwat Chon Buri, 20110
Thamonwan Ruangsrivoraporn, BNS, RN, +66 624966529, 6770031836@student.chula.ac.th
About this study
Official title: The Effect of Leg and Foot Massage Program on Pain in Newborns Receiving Heel Stick for Monitoring Serum Bilirubin Levels
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
- Being tested
- Leg and Foot Massage
- Keywords
- neonatal pain, Heel Prick, Heel Stick, Leg and foot massage, Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leg and Foot MassageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Leg and Foot Massage Group | Experimental | Newborns receive a standardized leg and foot massage before heel stick for monitoring serum bilirubin levels. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During heel stick and at 1, 3, and 5 minutes after heel stick.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural Pain in NewbornsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chollada Jongsomjitt, PhD, RN, Study chair, Faculty of Nursing, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893028
- Sponsor's protocol ID
- 016/2569
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.