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Not yet recruiting NCT07651592

MOTHER3SENSE Study

No phase Interventional Neonatal Pain Stress, Psychological

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Maternal Voice, Maternal Touch, Maternal Scent.
Who it may be relevant to
Registry conditions: Neonatal Pain, Stress, Psychological. Basic parameters: 0 Days — 28 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Maternal Voice, Touch, and Scent on Pain and Stress in Newborns: A Comparison of Three Sensory Interventions

Overview

This randomized controlled trial aims to compare the effects of maternal voice, touch, and scent on pain and stress levels in newborns during a routine heel lance procedure. Newborns will be randomly assigned to one of three intervention groups or a control group. Pain and stress responses will be assessed using validated neonatal pain and physiological measures. The findings of this study may help identify effective, low-cost, and non-pharmacological interventions that can be used to reduce pain and stress in newborns during routine clinical procedures.

Detailed description

Painful procedures are frequently performed in newborns during routine clinical care and may lead to physiological and behavioral stress responses. Non-pharmacological interventions are recommended as safe and effective approaches for reducing procedural pain and stress in newborns. Maternal sensory stimuli, including maternal voice, touch, and scent, may provide comfort and support neonatal regulation during painful procedures.

This randomized controlled trial aims to compare the effects of maternal voice, maternal touch, and maternal scent on pain and stress responses in newborns undergoing a routine heel lance procedure. Eligible newborns will be randomly assigned to one of four groups: maternal voice, maternal touch, maternal scent, or control.

The assigned intervention will be applied according to a standardized protocol before, during, and after the heel lance procedure. Pain and stress responses will be assessed at three time points: before the procedure, during the procedure, and after the procedure. Behavioral and physiological indicators will be used to evaluate neonatal pain and stress responses.

The primary objective of the study is to determine and compare the effectiveness of maternal voice, touch, and scent in reducing procedural pain and stress in newborns. The findings may contribute to evidence-based, family-centered, and non-pharmacological pain management practices in neonatal care.

Interventions

  • Other Maternal Voice
    The recorded maternal voice will be presented to the newborn before, during, and after the procedure.
  • Other Maternal Touch
    The mother will maintain contact with the newborn's palms before, during, and after the procedure to stimulate the grasp reflex and provide tactile sensory input.
  • Other Maternal Scent
    The newborn will be exposed to maternal breast milk scent during the procedure.

Primary outcome measures

  • Neonatal Infant Pain Scale [Time frame: Before the procedure, during the procedure, and immediately after the procedure]
Secondary outcome measures (1)
  • Newborn stress scale [Time frame: Before the procedure, during the procedure, and immediately after the procedure]

Eligibility criteria

Inclusion criteria

  • Term newborns born between 37 and 42 weeks of gestation
  • Newborns without respiratory, cardiac, metabolic, neurological, or infectious diseases
  • Newborns not requiring oxygen therapy, phototherapy, or intravenous treatment
  • Newborns scheduled to undergo a routine heel lance procedure (metabolic screening or blood sampling)
  • Mothers willing to participate in the study
  • Written informed consent provided by the parent or legal guardian
  • Normal vital signs before the procedure (heart rate, respiratory rate, and oxygen saturation within normal limits)

Exclusion criteria

  • Preterm (<37 weeks) or post-term (>42 weeks) newborns
  • Presence of congenital anomalies or neurological disorders
  • Requirement for oxygen therapy, phototherapy, or intravenous treatment
  • Respiratory, cardiac, metabolic, neurological, or infectious disease
  • Abnormal vital signs before the procedure
  • Parent or legal guardian refusal to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Kilis Alaeddin Yavaşça State Hospital — Kilis

Identifiers

NCT: NCT07651592 · Kilis 7 Aralık Universty · MOTHER3SENSE Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗