Neonatal PainMOTHER3SENSENCT07651592
MOTHER3SENSE Study
A study testing Maternal Voice, Maternal Touch and Maternal Scent in people with Neonatal Pain and Stress, Psychological, run by Kilis 7 Aralik University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Pain, Stress, Psychological
- What is being tested?
- Maternal Voice, Maternal Touch and Maternal Scent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kilis Alaeddin Yavaşça State Hospital
Kilis, 79000
Elif Simay KOÇ, +90 348 813 93 01, kocelifsimay@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Neonatal Pain, Stress, Psychological
- Being tested
- Maternal Voice, Maternal Touch, Maternal Scent
- Keywords
- Newborn, Maternal, Voice, Touch, Scent, Heel Lance, pain
- Medical subject headings
- Stress, Psychological, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal VoiceOther
The recorded maternal voice will be presented to the newborn before, during, and after the procedure.
Maternal TouchOther
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 ScentOther
The newborn will be exposed to maternal breast milk scent during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Maternal Voice | Experimental | The recorded maternal voice will be presented to the newborn before, during, and after the procedure. Receives: 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. Receives: Other: Maternal Touch |
| Maternal Scent | Experimental | The newborn will be exposed to maternal breast milk scent during the procedure. Receives: Other: Maternal Scent |
| Control | No intervention | Routine heel lance procedures will be performed, and no sensory intervention will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the procedure, during the procedure, and immediately after the procedure
Secondary outcomes (1)
Newborn stress scale
The Newborn Stress Scale (NSS), developed by Ceylan and Bolışık, consists of 24 items rated on a 3-point Likert scale.
Measured: Before the procedure, during the procedure, and immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kilis 7 Aralik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Simay KOÇ, Kilis 7 Aralik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651592
- Sponsor's protocol ID
- Kilis 7 Aralık Universty
- Other IDs
- MOTHER3SENSE Study
- Acronym
- MOTHER3SENSE
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Maternal Voice, Touch, and Scent on Pain and Stress in Newborns: A Comparison of Three Sensory Interventions
- ClinicalTrials.gov ID
- NCT07651592
- Acronym / sponsor ID
- MOTHER3SENSE / Kilis 7 Aralık Universty
- Conditions
- Neonatal Pain, Stress, Psychological
- Keywords
- Newborn, Maternal, Voice, Touch, Scent, Heel Lance, pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kilis 7 Aralik UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Maternal Voice | Experimental | Other: Maternal VoiceThe recorded maternal voice will be presented to the newborn before, during, and after the procedure. |
| Maternal Touch | Experimental | Other: Maternal TouchThe 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 | Experimental | Other: Maternal ScentThe newborn will be exposed to maternal breast milk scent during the procedure. |
| Control | No intervention | –Routine heel lance procedures will be performed, and no sensory intervention will be provided. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal VoiceThe recorded maternal voice will be presented to the newborn before, during, and after the procedure. | Other | Maternal Voice |
| Maternal TouchThe 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 ScentThe newborn will be exposed to maternal breast milk scent during the procedure. | Other | Maternal Scent |
Primary outcome
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.
1 secondary outcome
Newborn stress scale
Time frame: Before the procedure, during the procedure, and immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Neonatal Pain
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Leg and Foot Massage for Pain in Newborns Receiving Heel Stick
Procedural Pain in Newborns
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
RecruitingObservational study
Does Chronic Pain Change Over Time in Children With Duchenne Muscular Dystrophy?
Duchenne Muscular Dystrophy (DMD), Chronic Pain
Recruiting
Trans-auricular Nerve Stimulation as an Innovative Approach to the Treatment of Pain in Pediatric Patients Suffering From Sickle Cell Disease
Sickle Cell Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Voice, Maternal Touch and Maternal Scent in people with Neonatal Pain and Stress, Psychological, run by Kilis 7 Aralik University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif Simay KOÇ, Lecturer (+90 348 813 93 01, kocelifsimay@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Infant Pain Scale (time frame: Before the procedure, during the procedure, and immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.