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NCT Number: NCT07651592

MOTHER3SENSE Study

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.

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Key information

Conditions

Neonatal Pain Behavior Behavioral Symptoms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress, Psychological

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Maternal Voice

Other

The recorded maternal voice will be presented to the newborn before, during, and after the procedure.

Maternal Touch

Other

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.

Maternal Scent

Other

The newborn will be exposed to maternal breast milk scent during the procedure.

Primary outcomes

  1. Neonatal Infant Pain Scale

    Time frame: Before the procedure, during the procedure, and immediately after the procedure

    The Neonatal Infant Pain Scale (NIPS), originally developed by Lawrence et al. (1993), was adapted into Turkish by Akdovan (Akdovan & Yıldırım, 1999). NIPS is used to assess procedure-related pain in newborn infants. The scale evaluates five behavioral indicators-facial expression, crying, arm movements, leg movements, and state of arousal-as well as one physiological parameter, breathing pattern. Pain is assessed based on the evaluation of these behavioral and physiological responses.

Secondary outcomes

  1. Newborn stress scale

    Time frame: Before the procedure, during the procedure, and immediately after the procedure

    The Newborn Stress Scale (NSS), developed by Ceylan and Bolışık, consists of 24 items rated on a 3-point Likert scale.

Other outcomes

  1. Newborn and Maternal Characteristics Form

    Time frame: At baseline

    This researcher-developed form, based on the literature, was used to systematically collect demographic information about mothers and medical and birth-related characteristics of newborns.

  2. Neonatal Physiological Parameters Monitoring Form

    Time frame: Before the procedure, during the procedure, and immediately after the procedure

    The Newborn Physiological Parameters Assessment Form was developed by the researchers based on the literature and was used to evaluate physiological parameters, including heart rate, oxygen saturation, and body temperature, before, during, and after the heel lance procedure.

Study contacts

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

Elif Simay KOÇ, Lecturer

CONTACT

[email protected]

+90 348 813 93 01

Sponsors and collaborators

Lead sponsor

Kilis 7 Aralik University

Other

Registry information

Official study title

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

Acronym: MOTHER3SENSE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 16, 2026
Registry last updated
Jun 16, 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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