MOTHER3SENSE Study (MOTHER3SENSE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress, Psychological; Neonatal Pain
• Intervention / Treatment: Other: Maternal Voice; Other: Maternal Touch; Other: Maternal Scent

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elif Simay KOÇ, Lecturer; Phone Number: +90 348 813 93 01; Email: kocelifsimay@gmail.com

Study Locations

• Turkey (Türkiye)
  • Kilis, Turkey (Türkiye), 79000
    • Kilis Alaeddin Yavaşça State Hospital
    • Contact: Elif Simay KOÇ; Phone Number: +90 348 813 93 01; Email: kocelifsimay@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maternal Voice; The recorded maternal voice will be presented to the newborn before, during, and after the procedure.	Other: Maternal Voice; The recorded maternal voice will be presented to the newborn before, during, and after the procedure.
Experimental: 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 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.
Experimental: Maternal Scent; The newborn will be exposed to maternal breast milk scent during the procedure.	Other: Maternal Scent; The newborn will be exposed to maternal breast milk scent during the procedure.
No Intervention: Control; Routine heel lance procedures will be performed, and no sensory intervention will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Infant Pain Scale	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.	Before the procedure, during the procedure, and immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborn stress scale	The Newborn Stress Scale (NSS), developed by Ceylan and Bolışık, consists of 24 items rated on a 3-point Likert scale.	Before the procedure, during the procedure, and immediately after the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborn and Maternal Characteristics Form	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.	At baseline
Neonatal Physiological Parameters Monitoring Form	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.	Before the procedure, during the procedure, and immediately after the procedure

Collaborators and Investigators

• Sponsor: Kilis 7 Aralik University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: pain; Newborn; Maternal; Voice; Heel Lance; Touch; Scent
• Additional Relevant MeSH Terms: Neurologic Manifestations; Behavioral Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain; Stress, Psychological
• Other Study ID Numbers: Kilis 7 Aralık Universty; MOTHER3SENSE Study (Other Identifier: Kilis 7 Aralık Universty)

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