MOTHER3SENSE Study

NCT07651592 | Not Yet Recruiting

• 2 other identifiers: Kilis 7 Aralık UniverstyMOTHER3SENSE Study
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal Pain; Stress, Psychological

Keywords

Newborn; Maternal; Voice; Touch; Scent; Heel Lance; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Newborn stress scale

  Before the procedure, during the procedure, and immediately after the procedure

Other Outcomes (2)

• Newborn and Maternal Characteristics Form

  At baseline

• Neonatal Physiological Parameters Monitoring Form

  Before the procedure, during the procedure, and immediately after the procedure

Study Arms (4)

Maternal Voice

EXPERIMENTAL

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

Other: Maternal Voice

Maternal Touch

EXPERIMENTAL

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

Maternal Scent

EXPERIMENTAL

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

Other: Maternal Scent

Control

NO INTERVENTION

Routine heel lance procedures will be performed, and no sensory intervention will be provided.

Interventions

Maternal Voice OTHER

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

Maternal Voice

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 Touch

Maternal Scent OTHER

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

Maternal Scent

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kilis 7 Aralik University: lead

Study Sites (1)

Kilis Alaeddin Yavaşça State Hospital

Kilis, 79000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stress, Psychological; Pain

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elif Simay KOÇ, Lecturer

CONTACT

+90 348 813 93 01; kocelifsimay@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor responsible for evaluating pain and stress outcomes will be blinded to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)