Effect of Multisensory Stimulation on Pain During Heel Lance in Newborns

NCT07747649 | Recruiting

• 1 other identifier: MSS-HEEL-RCT-2026-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Procedural Pain in Newborns

Keywords

Multisensory Stimulation; Heel Lance; Neonatal Pain; Procedural Pain

Outcome Measures

Primary Outcomes (1)

• N-PASS Pain Score

  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 Outcomes (3)

• Crying Duration

  During the heel blood sampling session.

• Heart Rate

  Immediately before, during, and immediately after heel blood sampling.

• Oxygen Saturation

  Immediately before, during, and immediately after heel blood sampling.

Other Outcomes (1)

• Procedure Duration

  During a single heel blood sampling procedure

Study Arms (2)

Multisensory Stimulation Group

EXPERIMENTAL

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

Mother's Arms Control Group

NO INTERVENTION

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.

Interventions

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.

Multisensory Stimulation Group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Baskent University: lead

Study Sites (2)

Tatvan State Hospital

Ankara, Beşevler, 60300, Turkey (Türkiye)

RECRUITING

Bitlis State Hospita

Bitlis, Bitlis, 60300, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Garcia-Valdivieso I, Yanez-Araque B, Moncunill-Martinez E, Bocos-Reglero MJ, Gomez-Cantarino S. Effect of Non-Pharmacological Methods in the Reduction of Neonatal Pain: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2023 Feb 12;20(4):3226. doi: 10.3390/ijerph20043226.

  PMID: 36833919 BACKGROUND

• Jin L, Zhang J, Yang X, Rong H. Maternal voice reduces procedural pain in neonates: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2023 Mar 24;102(12):e33060. doi: 10.1097/MD.0000000000033060.

  PMID: 36961138 BACKGROUND

• Sahin K, Yildiz S, Gur E. The effect of multi-sensory stimuli used during vaccination on pain and physiological parameters in infants: A randomized controlled trial. J Pediatr Nurs. 2026 Mar-Apr;87:20-30. doi: 10.1016/j.pedn.2025.11.051. Epub 2026 Jan 6.

  PMID: 41500000 BACKGROUND

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

İlçim Ercan-Koyuncu, PhD

CONTACT

+905534700629; ilcimercan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: April 1, 2026
• Primary Completion: August 15, 2026
• Study Completion: August 15, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)