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A pilot randomized clinical trial to assess whether magnetic acupuncture reduces pain prior to painful procedures (heel prick) in neonates by comparing changes in cortisol levels and pain scores.

A pilot randomized clinical trial to assess whether magnetic acupuncture reduces pain prior to painful procedures (heel prick) in neonates by comparing changes in cortisol levels and pain scores.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000775314
Acronym
SERENUM trial (StrEss REduction in Neonates Using Magnetic acupuncture)
Enrollment
54
Registered
2026-06-29
Start date
2026-10-01
Completion date
2027-03-31
Last updated
2026-07-13

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

Conditions

None listed

Brief summary

This study will be a pilot randomized clinical trial to assess whether magnetic acupuncture reduces pain prior to painful procedures (heel prick) in neonates. Neonates born at greater or equal to 29 weeks gestational age and/or greater or equal to 1,000 grams will receive either auricular magnetic acupuncture or placebo 30 minutes prior to a painful procedure (heel prick). Changes in cortisol levels and pain scores pre and post procedure will be evaluated both in the intervention and placebo groups. The purpose is to investigate non-pharmacological ways to reduce pain in neonates.

Interventions

The magnetic acupuncture (MA) stickers (Sakamura, Helio Acupuncture, Japan) will be applied bilaterally in both ears to the five auricular acupuncture points as per the Battlefield Acupuncture (BFA) at least 30 minutes prior to a heel prick by the unblinded investigator. The BFA protocol has been used in both adults and children for management of acute pain conditions. All unblinded investigators administering the intervention will complete a one-hour BFA workshop delivered by experienced BFA p

The magnetic acupuncture (MA) stickers (Sakamura, Helio Acupuncture, Japan) will be applied bilaterally in both ears to the five auricular acupuncture points as per the Battlefield Acupuncture (BFA) at least 30 minutes prior to a heel prick by the unblinded investigator. The BFA protocol has been used in both adults and children for management of acute pain conditions. All unblinded investigators administering the intervention will complete a one-hour BFA workshop delivered by experienced BFA practitioner, All infants will receive standard care including sucrose prior to heel prick per local NICU guidelines; additional analgesic measures remain at clinical discretion. Stickers will remain in place for a maximum of three days or just prior to discharge from the neonatal unit, when they will be removed. Each infant will be followed up for the duration of the MA or placebo intervention, and stickers will be checked every eight hours by bedside nurses. The magnets have a strength of 100G and measure 1.7 mm in diameter on a circular sticker of surgical tape with diameter 10 mm. These magnets have already been used for pain management in the neonatal population with no side effects reported.

Sponsors

Sunshine Coast University hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
No minimum to 1 Months
Healthy volunteers
No

Inclusion criteria

• Neonates born at greater than or equal to 29 weeks gestational age and/or greater than or equal to 1,000 grams; • Admitted to the Special Care Baby Unit (SCBU) or Neonatal Intensive Care Unit (NICU) at SCUH; • Clinically indicated heel prick required during admission; • Written informed parental/guardian consent obtained prior to enrolment.

Exclusion criteria

• Currently requiring invasive respiratory support, sedation or humidification; • Major congenital abnormality interfering with pain perception; • Neurological conditions impairing pain perception; • Opioid or sedative treatment within 24 hours prior to the scheduled heel prick.

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 23, 2026