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Effect of Multisensory Stimulation on Pain During Heel Lance in Newborns

31 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

72

Fas

  • Inte tillämpbar

Kontakter och platser

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Studiekontakt

Studieorter

  • Turkiet (Türkiye)
    • Beşevler
      • Ankara, Beşevler, Turkiet (Türkiye), 60300
        • Rekrytering
        • Tatvan State Hospital
        • Kontakt:
    • Bitlis
      • Bitlis, Bitlis, Turkiet (Türkiye), 60300
        • Rekrytering
        • Bitlis State Hospita
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Ja

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: 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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
N-PASS Pain Score
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Crying Duration
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Procedure Duration
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Baskent University

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 april 2026

Primärt slutförande (Beräknad)

15 augusti 2026

Avslutad studie (Beräknad)

15 augusti 2026

Studieregistreringsdatum

Först inskickad

31 juli 2026

Först inskickad som uppfyllde QC-kriterierna

31 juli 2026

Första postat (Faktisk)

5 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MSS-HEEL-RCT-2026-01

Plan för individuella deltagardata (IPD)

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Läkemedels- och apparatinformation, studiedokument

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