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Investigating the effects of mechanical vibration and White Noise on the pain of heel lancing in premature infants.

Comparison of the effects of mechanical vibration and White Noise on heel lancing pain in premature infants hospitalized to the Neonatal Intensive Care Unit (NICU): A randomized controlled clinical trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250726066642N1
Enrollment
90
Registered
2025-10-23
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Pain experienced by newborns during heel lancing.

Interventions

Intervention 1: control group: Infants in the control group will receive 0.1 to 0.2 mL of 24% oral sucrose along with a pacifier or the mother’s finger, two minutes prior to heel lancing, in accordanc
amplitude: 0.6 mm) to the lateral mid-calf area of the infant, where the sural nerve passes. The vibration will continue throughout the procedure. Heel lancing will then be performed, and immediately

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 30 Days

Inclusion criteria

Inclusion criteria: Infants with a gestational age of 30-34 weeks At least one day has passed since hospitalization Infant being hospitalized into the incubator

Exclusion criteria

Exclusion criteria: Presence of any redness, swelling, or disruption in skin integrity at the site of vibration Presence of structural anomalies in the lower limb (such as clubfoot) Presence of hearing dysfunction (based on the result of the OAE hearing test) Presence of abnormalities that affect behavioral responses to pain, such as withdrawal syndrome or any type of hypotonia Receiving any sedative, analgesic, or anticonvulsant medication at least 12 hours before the intervention Presence of severe respiratory problems and the need for mechanical ventilation

Design outcomes

Primary

MeasureTime frame
Pain score for heel blood sampling in premature infants. Timepoint: pain scores will be obtained for the samples at three time points: one minute before, during, and one minute after heel lancing. Method of measurement: Infant pain will be assessed using the Premature Infant Pain Profile (PIPP) which includes physiological changes such as increased heart rate and decreased blood oxygen saturation from baseline, behavioral changes such as raised eyebrows, eye pressure, and nasolabial folds, and underlying conditions including gestational age and behavioral status. A score of 7 to 12 indicates mild to moderate pain, and a score above 12 indicates severe pain.

Secondary

MeasureTime frame
Duration of crying (the length of time from when the infant starts crying after a heel lance until the crying stops. Timepoint: The duration of crying will be measured from the moment the heel lance begins until one minute after the procedure ends. Method of measurement: the duration of the infant's crying will be measured using a mobile phone stopwatch for up to one minute following the procedure. If the crying continues beyond one minute, video recording will be continued until the infant stops crying completely.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactYalda Ahmadinia

Tabriz University of Medical Sciences

yaldaw.ahmadi@gmail.com+98 41 3336 4836

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026