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NCT Number: NCT07747649

Effect of Multisensory Stimulation on Pain During Heel Lance in Newborns

This randomized controlled study will evaluate whether multisensory stimulation can reduce pain in healthy newborns during heel blood sampling. Newborns will be assigned to either a multisensory stimulation group, which includes breastfeeding, gentle stroking, maternal singing, and eye contact, or a control group in which the procedure will be performed while the newborn is held in the mother's arms. Pain scores, crying duration, heart rate, oxygen saturation, and procedure duration will be compared between the groups.

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tatvan State Hospital, Ankara, Beşevler, Turkey (Türkiye)

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About this study

Heel blood sampling is a routine procedure used in newborn screening; however, it can produce pain, crying, and short-term changes in physiological parameters such as heart rate and oxygen saturation. Non-pharmacological approaches are commonly used to reduce procedural pain in newborns, but the effects of individual methods may be inconsistent. Multisensory stimulation combines several familiar and comforting sensory inputs and may reduce pain by directing attention away from the procedure, supporting autonomic regulation, and decreasing the stress response.

In this study, multisensory stimulation will consist of breastfeeding, gentle stroking of the leg, maternal singing or lullaby, and continuous eye contact between the mother and newborn. Breastfeeding and gentle stroking will begin 10 minutes before heel blood sampling and continue until 5 minutes after the procedure. Maternal singing and eye contact will be maintained throughout the procedure. The control condition will reflect supportive routine care, with the newborn held in the mother's arms during heel blood sampling.

The study will examine whether this structured multisensory approach reduces procedural pain and crying and supports physiological stability in healthy newborns. Pain, heart rate, and oxygen saturation will be assessed before, during, and after heel blood sampling. Crying duration and total procedure duration will also be recorded. The findings may contribute to the development of a safe, practical, and standardized non-pharmacological approach to pain management during routine newborn procedures.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy newborns aged 0-28 days
  • Newborns receiving routine monitoring and care with their mothers in the hospital's newborn care unit
  • Written informed consent provided by the newborn's parent or legal representative

Exclusion criteria

  • Presence of any lower-extremity anomaly
  • Ongoing monitoring or treatment in the neonatal intensive care unit
  • Presence of a congenital disease

Treatment and study plan

Multisensory Stimulation

Other

The multisensory stimulation intervention consists of four components: breastfeeding, gentle stroking, maternal singing or lullaby, and eye contact. Breastfeeding will begin 10 minutes before heel blood sampling and continue until 5 minutes after the procedure. During the same 15-minute period, the mother will gently stroke the newborn's leg from which the heel blood sample will be obtained. Throughout the heel blood sampling procedure, the mother will sing a lullaby or song in a soft and calm voice and maintain continuous eye contact with the newborn. No standardized song or lullaby will be prescribed, and the sound level will remain within the range of natural mother-newborn communication.

Primary outcomes

  1. N-PASS Pain Score

    Time frame: Immediately before, during, and immediately after heel blood sampling.

    Newborn pain will be assessed using the Neonatal Pain, Agitation and Sedation Scale (N-PASS). The scale evaluates crying or irritability, behavioral state, facial expression, extremity tone or body tension, and changes in vital signs. Higher pain scores indicate greater pain or agitation.

Secondary outcomes

  1. Crying Duration

    Time frame: During the heel blood sampling session.

    The total duration of crying associated with heel blood sampling will be measured using a stopwatch and recorded in seconds. A shorter crying duration indicates a more favorable outcome.

  2. Heart Rate

    Time frame: Immediately before, during, and immediately after heel blood sampling.

    Heart rate will be measured non-invasively using a bedside pulse oximeter and recorded as beats per minute. Heart rate values will be assessed to determine physiological responses to heel blood sampling and the multisensory stimulation intervention.

  3. Oxygen Saturation

    Time frame: Immediately before, during, and immediately after heel blood sampling.

    Peripheral oxygen saturation will be measured non-invasively using a bedside pulse oximeter and recorded as a percentage. Higher and more stable oxygen saturation values indicate a more favorable physiological response.

Other outcomes

  1. Procedure Duration

    Time frame: During a single heel blood sampling procedure

    The total duration of the heel blood sampling procedure will be measured using a stopwatch and recorded in seconds.

Study contacts

Contact information is provided by the study sponsor or research team.

İlçim Ercan-Koyuncu, PhD

CONTACT

[email protected]

+905534700629

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

The Effect of Multisensory Stimulation Applied During Heel Blood Sampling on Pain and Physiological Parameters in Newborns: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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