Effect of Multisensory Stimulation on Pain During Heel Lance in Newborns

July 31, 2026 updated by: Ilcim Ercan Koyuncu, Baskent University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Beşevler
      • Ankara, Beşevler, Turkey (Türkiye), 60300
        • Recruiting
        • Tatvan State Hospital
        • Contact:
    • Bitlis
      • Bitlis, Bitlis, Turkey (Türkiye), 60300
        • Recruiting
        • Bitlis State Hospita
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multisensory Stimulation Group
Newborns assigned to this arm will receive a structured multisensory stimulation intervention during heel blood sampling. The intervention will include 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 the procedure and continue until 5 minutes after the procedure. Maternal singing and eye contact will be maintained throughout heel blood sampling.
Other: Multisensory Stimulation
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.
No Intervention: Mother's Arms Control Group
Newborns assigned to this arm will receive routine heel blood sampling while being held in their mother's arms. No additional structured non-pharmacological pain-reduction intervention will be administered. When necessary, the mother may gently hold and support the newborn in a comfortable position during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately before, during, and immediately after heel blood sampling.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the heel blood sampling session.
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.
Immediately before, during, and immediately after heel blood sampling.
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.
Immediately before, during, and immediately after heel blood sampling.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During a single heel blood sampling procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 15, 2026

Study Registration Dates

First Submitted

July 31, 2026

First Submitted That Met QC Criteria

July 31, 2026

First Posted (Actual)

August 5, 2026

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSS-HEEL-RCT-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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