InfantNCT05526378
Effect of Three Different Sensory Interventions on Pain Level During Heel Blood Collection in Term Infant
A study testing Sensory Interventions in people with Infant and Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Background: Healthy newborns undergo many painful procedures in the first hours of life. Damage caused by painful procedures can lead to structural and functional changes that can affect adult life. Various non-pharmacological methods have been reported in the literature for pain management. Read more about this study
- Who is it for?
- Ages 24 to 48 hoursHealthy volunteers can take part
- What is being tested?
- Sensory Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Dec 2022to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 24 to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born between 37+0/7 - 41+6/7 gestational weeks,
- Gestational age and birth weight are compatible,
- Healthy newborns with stable vital signs.
Who cannot join
- Hearing problems,
- Suction problem
- Congenital anomaly,
- Need hospitalization in the neonatal intensive care unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Three Different Sensory Interventions on Pain Level During Heel Blood Collection in Term Infant: a Randomized Controlled Study
Background: Healthy newborns undergo many painful procedures in the first hours of life. Damage caused by painful procedures can lead to structural and functional changes that can affect adult life. Various non-pharmacological methods have been reported in the literature for pain management. The aim of the study is to investigate the effect of the method that appeals to 3 different senses (mother's voice, breast milk smell, mother's contact) on the level of pain during heel blood collection.
Method: The population of the study consisted of babies who were hospitalized in a hospital's neonatal unit between December 2022 and May 2023 and who heel blood taken. The Neonatal-Infant Pain (NIPS) Scale and data collection form were used to obtain the data. 120 newborns who met the study criteria were randomly divided into group 1 (n=30) , group 2 (n=30), group 3 (n=30), control group (n=30). All intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. The mother called her baby between 40 and 60 decibels loudness for group 1. Breast milk was dripped onto the gauze in an amount to wet the entire 2,5cm*2,5cm sterile gauze and the gauze was then placed close to the baby's nose wings for group 2. Skin-to-skin contact between mother and baby is provided for group 3. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure for all groups.
- Being tested
- Sensory Interventions
- Keywords
- infant, pain, mother's milk, mother's voice, skin contact
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory InterventionsBehavioural
Group 1 will be hear mother's voice before, during and after the procedure. Group 2 will be sniffed mother's breast milk before, during and after the procedure.
Group 3 will be skin contact with mother's before, during and after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (mother's voice) | Experimental | The mother called her baby between 40 and 60 decibels loudness. The intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure.
Benetech brand GM1352 model decibel meter was used to measure the loudness. Receives: Behavioral: Sensory Interventions |
| Group 2 (mother's milk) | Experimental | Breast milk was dripped onto the gauze in an amount to wet the entire 2,5cm*2,5cm sterile gauze. The gauze was then placed close to the baby's nose wings. The intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure Receives: Behavioral: Sensory Interventions |
| Group 3 (skin to skin contact) | Experimental | Skin-to-skin contact between mother and baby is provided. The intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure Receives: Behavioral: Sensory Interventions |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIPS scale
Neonatal Infant Pain Scale (NIPS) consists of 6 items (facial expression, crying, breathing pattern, arms, legs, alertness) and is evaluated between 0-7 points in total. As the score increases, the level of pain increases.
Measured: Expecting during procedure
NIPS scale
Neonatal Infant Pain Scale (NIPS) consists of 6 items (facial expression, crying, breathing pattern, arms, legs, alertness) and is evaluated between 0-7 points in total. As the score increases, the level of pain increases.
Measured: 5 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start22 Dec 2022
- Primary completion15 Apr 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for InfantStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Dogan, Istanbul University - Cerrahpasa
- Investigators
- Elif Dogan, Principal investigator, Researcher Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526378
- Sponsor's protocol ID
- 2022/94
- Status last verified
- Jul 2023
- First submitted
- 20 Aug 2022
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin CH, Liaw JJ, Chen YT, Yin T, Yang L, Lan HY. Efficacy of Breast Milk Olfactory and Gustatory Interventions on Neonates' Biobehavioral Responses to Pain during Heel Prick Procedures. Int J Environ Res Public Health. 2022 Jan 22;19(3):1240. doi: 10.3390/ijerph19031240.
PubMed 35162263McPherson C, Miller SP, El-Dib M, Massaro AN, Inder TE. The influence of pain, agitation, and their management on the immature brain. Pediatr Res. 2020 Aug;88(2):168-175. doi: 10.1038/s41390-019-0744-6. Epub 2020 Jan 2.
PubMed 31896130McNair C, Campbell-Yeo M, Johnston C, Taddio A. Nonpharmacologic Management of Pain During Common Needle Puncture Procedures in Infants: Current Research Evidence and Practical Considerations: An Update. Clin Perinatol. 2019 Dec;46(4):709-730. doi: 10.1016/j.clp.2019.08.006. Epub 2019 Aug 26.
PubMed 31653304Zhang S, Su F, Li J, Chen W. The Analgesic Effects of Maternal Milk Odor on Newborns: A Meta-Analysis. Breastfeed Med. 2018 Jun;13(5):327-334. doi: 10.1089/bfm.2017.0226. Epub 2018 May 7.
PubMed 29733222Benoit B, Newman A, Martin-Misener R, Latimer M, Campbell-Yeo M. The influence of breastfeeding on cortical and bio-behavioural indicators of procedural pain in newborns: Findings of a randomized controlled trial. Early Hum Dev. 2021 Mar;154:105308. doi: 10.1016/j.earlhumdev.2021.105308. Epub 2021 Jan 12.
PubMed 33513546Kucuk Alemdar D, Kardas Ozdemir F. Effects of Having Preterm Infants Smell Amniotic Fluid, Mother's Milk, and Mother's Odor During Heel Stick Procedure on Pain, Physiological Parameters, and Crying Duration. Breastfeed Med. 2017 Jun;12:297-304. doi: 10.1089/bfm.2017.0006. Epub 2017 Apr 17.
PubMed 28414516Yilmaz D, Yilmaz Kurt F. The effect of foot reflexology on procedural pain before heel lancing in neonates. Arch Pediatr. 2021 May;28(4):278-284. doi: 10.1016/j.arcped.2021.02.015. Epub 2021 Mar 11.
PubMed 33715931Filippa M, Devouche E, Arioni C, Imberty M, Gratier M. Live maternal speech and singing have beneficial effects on hospitalized preterm infants. Acta Paediatr. 2013 Oct;102(10):1017-20. doi: 10.1111/apa.12356. Epub 2013 Aug 8.
PubMed 23848529Cakirli M, Acikgoz A. A Randomized Controlled Trial: The Effect of Own Mother's Breast Milk Odor and Another Mother's Breast Milk Odor on Pain Level of Newborn Infants. Breastfeed Med. 2021 Jan;16(1):75-81. doi: 10.1089/bfm.2020.0222. Epub 2020 Oct 20.
PubMed 33085532Filippa M, Monaci MG, Spagnuolo C, Serravalle P, Daniele R, Grandjean D. Maternal speech decreases pain scores and increases oxytocin levels in preterm infants during painful procedures. Sci Rep. 2021 Aug 27;11(1):17301. doi: 10.1038/s41598-021-96840-4.
PubMed 34453088Duman R, Dogan E, Kaya HD, Tepe M. The Effect of Three Different Sensory Interventions (Mother's Voice, Mother's Milk, and Mother's Holding) During Heel Lance on Pain Level in Term Newborns: A Randomized Controlled Trial. Breastfeed Med. 2025 May;20(5):345-352. doi: 10.1089/bfm.2024.0197. Epub 2025 Feb 7.
PubMed 39918942
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Three Different Sensory Interventions on Pain Level During Heel Blood Collection in Term Infant: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05526378
- Acronym / sponsor ID
- 2022/94
- Keywords
- infant, pain, mother's milk, mother's voice, skin contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 2 Sep 2022 (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.
Background: Healthy newborns undergo many painful procedures in the first hours of life. Damage caused by painful procedures can lead to structural and functional changes that can affect adult life. Various non-pharmacological methods have been reported in the literature for pain management. The aim of the study is to investigate the effect of the method that appeals to 3 different senses (mother's voice, breast milk smell, mother's contact) on the level of pain during heel blood collection.
Method: The population of the study consisted of babies who were hospitalized in a hospital's neonatal unit between December 2022 and May 2023 and who heel blood taken. The Neonatal-Infant Pain (NIPS) Scale and data collection form were used to obtain the data. 120 newborns who met the study criteria were randomly divided into group 1 (n=30) , group 2 (n=30), group 3 (n=30), control group (n=30). All intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. The mother called her baby between 40 and 60 decibels loudness for group 1. Breast milk was dripped onto the gauze in an amount to wet the entire 2,5cm*2,5cm sterile gauze and the gauze was then placed close to the baby's nose wings for group 2. Skin-to-skin contact between mother and baby is provided for group 3. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure for all groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (mother's voice) | Experimental | Behavioral: Sensory InterventionsThe mother called her baby between 40 and 60 decibels loudness. The intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. Benetech brand GM1352 model decibel meter was used to measure the loudness. |
| Group 2 (mother's milk) | Experimental | Behavioral: Sensory InterventionsBreast milk was dripped onto the gauze in an amount to wet the entire 2,5cm*2,5cm sterile gauze. The gauze was then placed close to the baby's nose wings. The intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure |
| Group 3 (skin to skin contact) | Experimental | Behavioral: Sensory InterventionsSkin-to-skin contact between mother and baby is provided. The intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure |
| Control group | No intervention | – |
Who may qualify
- Ages
- 24 to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Born between 37+0/7 - 41+6/7 gestational weeks,
- Gestational age and birth weight are compatible,
- Healthy newborns with stable vital signs.
Key exclusion criteria (4 listed)
- Hearing problems,
- Suction problem
- Congenital anomaly,
- Need hospitalization in the neonatal intensive care unit.
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 |
|---|---|---|
| Sensory InterventionsGroup 1 will be hear mother's voice before, during and after the procedure. Group 2 will be sniffed mother's breast milk before, during and after the procedure. Group 3 will be skin contact with mother's before, during and after the procedure. | Behavioural | Group 1 (mother's voice), Group 2 (mother's milk), Group 3 (skin to skin contact) |
Primary outcome
NIPS scale
Time frame: Expecting during procedure
Neonatal Infant Pain Scale (NIPS) consists of 6 items (facial expression, crying, breathing pattern, arms, legs, alertness) and is evaluated between 0-7 points in total. As the score increases, the level of pain increases.
NIPS scale
Time frame: 5 minutes after procedure
Neonatal Infant Pain Scale (NIPS) consists of 6 items (facial expression, crying, breathing pattern, arms, legs, alertness) and is evaluated between 0-7 points in total. As the score increases, the level of pain increases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Background: PubMed 35162263Lin CH, Liaw JJ, Chen YT, Yin T, Yang L, Lan HY. Efficacy of Breast Milk Olfactory and Gustatory Interventions on Neonates' Biobehavioral Responses to Pain during Heel Prick Procedures. Int J Environ Res Public Health. 2022 Jan 22;19(3):1240. doi: 10.3390/ijerph19031240.
- Background: PubMed 31896130McPherson C, Miller SP, El-Dib M, Massaro AN, Inder TE. The influence of pain, agitation, and their management on the immature brain. Pediatr Res. 2020 Aug;88(2):168-175. doi: 10.1038/s41390-019-0744-6. Epub 2020 Jan 2.
- Background: PubMed 31653304McNair C, Campbell-Yeo M, Johnston C, Taddio A. Nonpharmacologic Management of Pain During Common Needle Puncture Procedures in Infants: Current Research Evidence and Practical Considerations: An Update. Clin Perinatol. 2019 Dec;46(4):709-730. doi: 10.1016/j.clp.2019.08.006. Epub 2019 Aug 26.
- Background: PubMed 29733222Zhang S, Su F, Li J, Chen W. The Analgesic Effects of Maternal Milk Odor on Newborns: A Meta-Analysis. Breastfeed Med. 2018 Jun;13(5):327-334. doi: 10.1089/bfm.2017.0226. Epub 2018 May 7.
- Background: PubMed 33513546Benoit B, Newman A, Martin-Misener R, Latimer M, Campbell-Yeo M. The influence of breastfeeding on cortical and bio-behavioural indicators of procedural pain in newborns: Findings of a randomized controlled trial. Early Hum Dev. 2021 Mar;154:105308. doi: 10.1016/j.earlhumdev.2021.105308. Epub 2021 Jan 12.
- Background: PubMed 28414516Kucuk Alemdar D, Kardas Ozdemir F. Effects of Having Preterm Infants Smell Amniotic Fluid, Mother's Milk, and Mother's Odor During Heel Stick Procedure on Pain, Physiological Parameters, and Crying Duration. Breastfeed Med. 2017 Jun;12:297-304. doi: 10.1089/bfm.2017.0006. Epub 2017 Apr 17.
- Background: PubMed 33715931Yilmaz D, Yilmaz Kurt F. The effect of foot reflexology on procedural pain before heel lancing in neonates. Arch Pediatr. 2021 May;28(4):278-284. doi: 10.1016/j.arcped.2021.02.015. Epub 2021 Mar 11.
- Background: PubMed 23848529Filippa M, Devouche E, Arioni C, Imberty M, Gratier M. Live maternal speech and singing have beneficial effects on hospitalized preterm infants. Acta Paediatr. 2013 Oct;102(10):1017-20. doi: 10.1111/apa.12356. Epub 2013 Aug 8.
- Background: PubMed 33085532Cakirli M, Acikgoz A. A Randomized Controlled Trial: The Effect of Own Mother's Breast Milk Odor and Another Mother's Breast Milk Odor on Pain Level of Newborn Infants. Breastfeed Med. 2021 Jan;16(1):75-81. doi: 10.1089/bfm.2020.0222. Epub 2020 Oct 20.
- Background: PubMed 34453088Filippa M, Monaci MG, Spagnuolo C, Serravalle P, Daniele R, Grandjean D. Maternal speech decreases pain scores and increases oxytocin levels in preterm infants during painful procedures. Sci Rep. 2021 Aug 27;11(1):17301. doi: 10.1038/s41598-021-96840-4.
- Derived from this study: PubMed 39918942Duman R, Dogan E, Kaya HD, Tepe M. The Effect of Three Different Sensory Interventions (Mother's Voice, Mother's Milk, and Mother's Holding) During Heel Lance on Pain Level in Term Newborns: A Randomized Controlled Trial. Breastfeed Med. 2025 May;20(5):345-352. doi: 10.1089/bfm.2024.0197. Epub 2025 Feb 7.
- Individual participant dataSharing planned: No
Related trials for Infant
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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. This study is not recruiting at the moment.
Elif Dogan principal investigator
Researcher Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Interventions in people with Infant and Pain, run by Istanbul University - Cerrahpasa 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 18 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIPS scale (time frame: Expecting during procedure). The study lists 2 primary outcomes in all. 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 NCT05526378, which also lists 11 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 18 Oct 2024.