Procedural Pain in NewbornsNCT07747649
Effect of Multisensory Stimulation on Pain During Heel Lance in Newborns
A study testing Multisensory Stimulation in people with Procedural Pain in Newborns, run by Baskent University at 2 sites in Turkey (Türkiye).
Trial summary
This randomized controlled study will evaluate whether multisensory stimulation can reduce pain in healthy newborns during heel blood sampling. Newborns will be assigned to either a multisensory stimulation group, which includes breastfeeding, gentle stroking, maternal singing, and eye contact, or a control group in… Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain in Newborns
- What is being tested?
- Multisensory Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 15 Aug 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 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborns aged 0-28 days
- Newborns receiving routine monitoring and care with their mothers in the hospital's newborn care unit
- Written informed consent provided by the newborn's parent or legal representative
Who cannot join
- Presence of any lower-extremity anomaly
- Ongoing monitoring or treatment in the neonatal intensive care unit
- Presence of a congenital disease
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Tatvan State Hospital
Ankara, Beşevler, 60300
İlçim Ercan-Koyuncu, 05534700629, ilcimercan@hotmail.com
- Recruiting
Bitlis State Hospita
Bitlis, Bitlis, 60300
İlçim Ercan-Koyuncu, 05534700629, ilcimercan@hotmail.com
About this study
Official title: The Effect of Multisensory Stimulation Applied During Heel Blood Sampling on Pain and Physiological Parameters in Newborns: A Randomized Controlled Trial
This randomized controlled study will evaluate whether multisensory stimulation can reduce pain in healthy newborns during heel blood sampling. Newborns will be assigned to either a multisensory stimulation group, which includes breastfeeding, gentle stroking, maternal singing, and eye contact, or a control group in which the procedure will be performed while the newborn is held in the mother's arms. Pain scores, crying duration, heart rate, oxygen saturation, and procedure duration will be compared between the groups.
Read the detailed description
Heel blood sampling is a routine procedure used in newborn screening; however, it can produce pain, crying, and short-term changes in physiological parameters such as heart rate and oxygen saturation. Non-pharmacological approaches are commonly used to reduce procedural pain in newborns, but the effects of individual methods may be inconsistent. Multisensory stimulation combines several familiar and comforting sensory inputs and may reduce pain by directing attention away from the procedure, supporting autonomic regulation, and decreasing the stress response.
In this study, multisensory stimulation will consist of breastfeeding, gentle stroking of the leg, maternal singing or lullaby, and continuous eye contact between the mother and newborn. Breastfeeding and gentle stroking will begin 10 minutes before heel blood sampling and continue until 5 minutes after the procedure. Maternal singing and eye contact will be maintained throughout the procedure. The control condition will reflect supportive routine care, with the newborn held in the mother's arms during heel blood sampling.
The study will examine whether this structured multisensory approach reduces procedural pain and crying and supports physiological stability in healthy newborns. Pain, heart rate, and oxygen saturation will be assessed before, during, and after heel blood sampling. Crying duration and total procedure duration will also be recorded. The findings may contribute to the development of a safe, practical, and standardized non-pharmacological approach to pain management during routine newborn procedures.
- Conditions
- Procedural Pain in Newborns
- Being tested
- Multisensory Stimulation
- Keywords
- Multisensory Stimulation, Heel Lance, Neonatal Pain, Procedural Pain
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory StimulationOther
The multisensory stimulation intervention consists of four components: breastfeeding, gentle stroking, maternal singing or lullaby, and eye contact. Breastfeeding will begin 10 minutes before heel blood sampling and continue until 5 minutes after the procedure. During the same 15-minute period, the mother will gently stroke the newborn's leg from which the heel blood sample will be obtained. Throughout the heel blood sampling procedure, the mother will sing a lullaby or song in a soft and calm voice and maintain continuous eye contact with the newborn. No standardized song or lullaby will be prescribed, and the sound level will remain within the range of natural mother-newborn communication.
| Study group | Role | What they receive |
|---|---|---|
| Multisensory Stimulation Group | Experimental | Newborns assigned to this arm will receive a structured multisensory stimulation intervention during heel blood sampling. The intervention will include breastfeeding, gentle stroking of the leg, maternal singing or lullaby, and continuous eye contact between the mother and newborn. Breastfeeding and gentle stroking will begin 10 minutes before the procedure and continue until 5 minutes after the procedure. Maternal singing and eye contact will be maintained throughout heel blood sampling. Receives: Other: Multisensory Stimulation |
| Mother's Arms Control Group | No intervention | Newborns assigned to this arm will receive routine heel blood sampling while being held in their mother's arms. No additional structured non-pharmacological pain-reduction intervention will be administered. When necessary, the mother may gently hold and support the newborn in a comfortable position during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-PASS Pain Score
Newborn pain will be assessed using the Neonatal Pain, Agitation and Sedation Scale (N-PASS). The scale evaluates crying or irritability, behavioral state, facial expression, extremity tone or body tension, and changes in vital signs. Higher pain scores indicate greater pain or agitation.
Measured: Immediately before, during, and immediately after heel blood sampling.
Secondary outcomes (3)
Crying Duration
The total duration of crying associated with heel blood sampling will be measured using a stopwatch and recorded in seconds. A shorter crying duration indicates a more favorable outcome.
Measured: During the heel blood sampling session.
Heart Rate
Heart rate will be measured non-invasively using a bedside pulse oximeter and recorded as beats per minute. Heart rate values will be assessed to determine physiological responses to heel blood sampling and the multisensory stimulation intervention.
Measured: Immediately before, during, and immediately after heel blood sampling.
Oxygen Saturation
Peripheral oxygen saturation will be measured non-invasively using a bedside pulse oximeter and recorded as a percentage. Higher and more stable oxygen saturation values indicate a more favorable physiological response.
Measured: Immediately before, during, and immediately after heel blood sampling.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Apr 2026
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Procedural Pain in NewbornsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilcim Ercan Koyuncu, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747649
- Sponsor's protocol ID
- MSS-HEEL-RCT-2026-01
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-Valdivieso I, Yanez-Araque B, Moncunill-Martinez E, Bocos-Reglero MJ, Gomez-Cantarino S. Effect of Non-Pharmacological Methods in the Reduction of Neonatal Pain: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2023 Feb 12;20(4):3226. doi: 10.3390/ijerph20043226.
PubMed 36833919Jin L, Zhang J, Yang X, Rong H. Maternal voice reduces procedural pain in neonates: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2023 Mar 24;102(12):e33060. doi: 10.1097/MD.0000000000033060.
PubMed 36961138Sahin K, Yildiz S, Gur E. The effect of multi-sensory stimuli used during vaccination on pain and physiological parameters in infants: A randomized controlled trial. J Pediatr Nurs. 2026 Mar-Apr;87:20-30. doi: 10.1016/j.pedn.2025.11.051. Epub 2026 Jan 6.
PubMed 41500000
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multisensory Stimulation Applied During Heel Blood Sampling on Pain and Physiological Parameters in Newborns: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07747649
- Acronym / sponsor ID
- MSS-HEEL-RCT-2026-01
- Conditions
- Procedural Pain in Newborns
- Keywords
- Multisensory Stimulation, Heel Lance, Neonatal Pain, Procedural Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 5 Aug 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 study will evaluate whether multisensory stimulation can reduce pain in healthy newborns during heel blood sampling. Newborns will be assigned to either a multisensory stimulation group, which includes breastfeeding, gentle stroking, maternal singing, and eye contact, or a control group in which the procedure will be performed while the newborn is held in the mother's arms. Pain scores, crying duration, heart rate, oxygen saturation, and procedure duration will be compared between the groups.
Detailed description
Heel blood sampling is a routine procedure used in newborn screening; however, it can produce pain, crying, and short-term changes in physiological parameters such as heart rate and oxygen saturation. Non-pharmacological approaches are commonly used to reduce procedural pain in newborns, but the effects of individual methods may be inconsistent. Multisensory stimulation combines several familiar and comforting sensory inputs and may reduce pain by directing attention away from the procedure, supporting autonomic regulation, and decreasing the stress response.
In this study, multisensory stimulation will consist of breastfeeding, gentle stroking of the leg, maternal singing or lullaby, and continuous eye contact between the mother and newborn. Breastfeeding and gentle stroking will begin 10 minutes before heel blood sampling and continue until 5 minutes after the procedure. Maternal singing and eye contact will be maintained throughout the procedure. The control condition will reflect supportive routine care, with the newborn held in the mother's arms during heel blood sampling.
The study will examine whether this structured multisensory approach reduces procedural pain and crying and supports physiological stability in healthy newborns. Pain, heart rate, and oxygen saturation will be assessed before, during, and after heel blood sampling. Crying duration and total procedure duration will also be recorded. The findings may contribute to the development of a safe, practical, and standardized non-pharmacological approach to pain management during routine newborn procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multisensory Stimulation Group | Experimental | Other: Multisensory StimulationNewborns assigned to this arm will receive a structured multisensory stimulation intervention during heel blood sampling. The intervention will include breastfeeding, gentle stroking of the leg, maternal singing or lullaby, and continuous eye contact between the mother and newborn. Breastfeeding and gentle stroking will begin 10 minutes before the procedure and continue until 5 minutes after the procedure. Maternal singing and eye contact will be maintained throughout heel blood sampling. |
| Mother's Arms Control Group | No intervention | –Newborns assigned to this arm will receive routine heel blood sampling while being held in their mother's arms. No additional structured non-pharmacological pain-reduction intervention will be administered. When necessary, the mother may gently hold and support the newborn in a comfortable position during the procedure. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy newborns aged 0-28 days
- Newborns receiving routine monitoring and care with their mothers in the hospital's newborn care unit
- Written informed consent provided by the newborn's parent or legal representative
Key exclusion criteria (3 listed)
- Presence of any lower-extremity anomaly
- Ongoing monitoring or treatment in the neonatal intensive care unit
- Presence of a congenital disease
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 |
|---|---|---|
| Multisensory StimulationThe multisensory stimulation intervention consists of four components: breastfeeding, gentle stroking, maternal singing or lullaby, and eye contact. Breastfeeding will begin 10 minutes before heel blood sampling and continue until 5 minutes after the procedure. During the same 15-minute period, the mother will gently stroke the newborn's leg from which the heel blood sample will be obtained. Throughout the heel blood sampling procedure, the mother will sing a lullaby or song in a soft and calm voice and maintain continuous eye contact with the newborn. No standardized song or lullaby will be prescribed, and the sound level will remain within the range of natural mother-newborn communication. | Other | Multisensory Stimulation Group |
Primary outcome
N-PASS Pain Score
Time frame: Immediately before, during, and immediately after heel blood sampling.
Newborn pain will be assessed using the Neonatal Pain, Agitation and Sedation Scale (N-PASS). The scale evaluates crying or irritability, behavioral state, facial expression, extremity tone or body tension, and changes in vital signs. Higher pain scores indicate greater pain or agitation.
3 secondary outcomes
Crying Duration
Time frame: During the heel blood sampling session.
Heart Rate
Time frame: Immediately before, during, and immediately after heel blood sampling.
Oxygen Saturation
Time frame: Immediately before, during, and immediately after heel blood sampling.
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 5 Aug 2026.
- Background: PubMed 36833919Garcia-Valdivieso I, Yanez-Araque B, Moncunill-Martinez E, Bocos-Reglero MJ, Gomez-Cantarino S. Effect of Non-Pharmacological Methods in the Reduction of Neonatal Pain: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2023 Feb 12;20(4):3226. doi: 10.3390/ijerph20043226.
- Background: PubMed 36961138Jin L, Zhang J, Yang X, Rong H. Maternal voice reduces procedural pain in neonates: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2023 Mar 24;102(12):e33060. doi: 10.1097/MD.0000000000033060.
- Background: PubMed 41500000Sahin K, Yildiz S, Gur E. The effect of multi-sensory stimuli used during vaccination on pain and physiological parameters in infants: A randomized controlled trial. J Pediatr Nurs. 2026 Mar-Apr;87:20-30. doi: 10.1016/j.pedn.2025.11.051. Epub 2026 Jan 6.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisensory Stimulation in people with Procedural Pain in Newborns, run by Baskent University at 2 sites 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 İlçim Ercan-Koyuncu, PhD (+905534700629, ilcimercan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-PASS Pain Score (time frame: Immediately before, during, and immediately after heel blood sampling.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07747649, which also lists 3 linked publications.
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 5 Aug 2026.