PainNCT05444608
Premature Newborn Pain Management: The Effects of Breast Milk Odor and White Noise
A study testing Breast milk olfactory stimulation and White noise auditory stimulation in people with Pain, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This study will conduct to evaluate the effect of using white noise and breast milk odor on pain during heel lance procedure in premature newborns. This study is a randomized controlled trial. The study will conduct with premature newborns who were born between 34 and 37 weeks of gestation. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Breast milk olfactory stimulation and White noise auditory stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2022to 1 Oct 2022
- 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 Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- gestational age between 34 and 37 weeks
- birth weight over 1500 g
- Taking blood from the heel for the purpose of measuring blood sugar
- Starting feeding with breast milk
- Parental consent
Who cannot join
- Having a chromosomal abnormality
- Presence of neonatal seizures
- Presence of intracranial bleeding (grade III-IV)
- Presence of craniofacial malformation
- Presence of congenital hearing loss
- Babies with perinatal asphyxia
- Babies using sedatives, muscle relaxants and antiepileptics
- Babies whose mothers have a history of substance use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Use of Breast Milk Odor and White Noise on Pain Management During Heel Lance in Premature Newborns: A Randomized Controlled Study
This study will conduct to evaluate the effect of using white noise and breast milk odor on pain during heel lance procedure in premature newborns. This study is a randomized controlled trial.
The study will conduct with premature newborns who were born between 34 and 37 weeks of gestation. The premature newborns will be divided into three groups by application of pain relief methods during heel lance to check blood sugar in newborns. These groups can be described as breast milk odor (n=22), white noise (n=22) and control group (n=22). The intervention will start 5 minutes before the procedure and last 5 minutes after the procedure. The infants will be recorded with a video camera by researcher before, during, and after the procedure. Premature Infant Pain Profile Revised (PIPP-R) will be used for pain grading.
Read the detailed description
The sense of pain develops in infants after the 20th gestational weeks with the initiation of communication between the cortex and the thalamus. Babies in the newborn period can respond physiologically, behaviorally and hormonal to painful stimuli which they experienced. Responses that emerge as a result of pain experience may adversely affect the current state of the newborn and its growth and development in the long term. One of the painful procedures that the newborn is frequently exposed to at the beginning of the extra-uterine life is blood collection from the heel. Pharmacological and non-pharmacological methods can be applied to alleviate the pain sensation experienced by newborns during these procedures. The existence of possible side effects of pharmacological methods has led to need to use non-pharmacological methods more effectively. In this study, it was aimed to investigate the effectiveness of breast milk odor and white noise, which are non-pharmacological methods, to the pain caused by heel puncture.
Main hypothesizes of the study can be listed as:
H11: Breast milk smelling during heel lancing in preterm newborn infants effectively reduces the infant's procedure-related pain.
H01: Breast milk smelling during heel lancing in preterm newborn infants is not effective in reducing the procedure-related pain of the infant.
H12: Listening to white noise during heel lancing in preterm newborn babies effectively reduces the baby's procedure-related pain.
H02: Listening to white noise during heel lancing in preterm newborn infants is not effective in reducing the procedure-related pain of the infant.
H13: Breast milk smelling during heel puncture in preterm newborn infants is more effective than white noise in reducing the procedure-related pain of the infant.
H03: Breast milk smelling during heel puncture in preterm newborn infants is not more effective than white noise in reducing the procedure-related pain of the infant.
H14: Listening to white noise during heel lancing in preterm newborn babies is more effective than breast milk odor in reducing the procedure-related pain of the baby.
H04: Listening to white noise during heel lancing in preterm newborn babies is not more effective than breast milk odor in reducing the procedure-related pain of the infant.
The population of the study will consist of preterm babies born between 34-37 weeks of gestation, who were hospitalized in the Neonatal Intensive Care Unit mother-baby room, and postnatal service of Ankara University Faculty of Medicine, Cebeci Application and Research Hospital, between May 2022 and October 2022 and for whom heel blood sampling is requested.The sample of the study will consist of 66 (white noise=22, breast milk odor=22, control=22) infants who met the case selection criteria and were randomly assigned to groups. Babies will be made to listen to white noise or smell breast milk for 5 minutes before the heel blood collection procedure, during the procedure and 5 minutes after the procedure in accordance with the group they are involved. Only routine nursing care will be applied to the control group, no additional intervention. All the infants in three different groups will be recorded by video camera. Recording will start 5 minutes before the heel lance procedure and continue during the procedure and 5 minutes after the procedure. Pain assessments will be made by another researcher through video recordings. Newborns pain will evaluate with the PIPP-R pain scale 5 minutes before procedure (at the beginnings of intervention), 2 minutes before procedure, at the time of the procedure and 5 minutes after the procedure. Heart rate and oxygen saturation will be recorded at the same times.
- Conditions
- Pain
- Being tested
- Breast milk olfactory stimulation, White noise auditory stimulation
- Keywords
- Newborn, Pain, Breast milk odor, White noise, Heel lance
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast milk olfactory stimulationBehavioural
Before the intervention, 2 ml of breast milk will be dripped into sterile sponge and the sponge will be placed within 3 cm of the newborn's nose.Babies in this group will start to smell their mother's milk 5 minutes before the procedure and will continue to smell for 5 minutes after the procedure.
White noise auditory stimulationBehavioural
Before the intervention, a bluetooth speaker will be placed at the baby's feet. The speaker will be connected to the phone and the sound level will be adjusted to 50 decibels by means of a decibel meter. The baby will be started to listen to white noise 5 minutes before the procedure and will continue to listen for 5 minutes after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Data will be collected during heel blood sampling for blood sugar control from newborns randomly assigned to the control group. Babies in the control group will not be allowed to smell breast milk or listen to white noise.The newborn in the control group will continue to receive routine care.Camera recording will start 5 minutes before the procedure and lasting 5 minutes after the procedure. |
| Breast Milk Odor Group | Experimental | Data will be collected during heel blood sampling for blood sugar control from newborns randomly assigned to the breast milk odor group.Before the intervention, 2 ml of breast milk will be dripped into sterile sponge and the sponge will be placed within 3 cm of the newborn's nose.Babies in this group will start to smell their mother's milk 5 minutes before the procedure and will continue to smell for 5 minutes after the procedure.Camera recording will start 5 minutes before the procedure and lasting 5 minutes after the procedure. Receives: Behavioral: Breast milk olfactory stimulation |
| White Noise Group | Experimental | Data will be collected during heel blood sampling for blood sugar control from newborns randomly assigned to the white noise listening group.Before the intervention , a bluetooth speaker will be placed at the baby's feet. The speaker will be connected to the phone and the sound level will be adjusted to 50 decibels by means of a decibel meter. The baby will be started to listen to white noise 5 minutes before the procedure.Camera recording will start 5 minutes before the procedure and lasting 5 minutes after the procedure. Receives: Behavioral: White noise auditory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Pain
Premature Infant Pain Profile-Revised
The scale includes seven criteria. Facial expressions (frown, squint, prominence of the nasolabial groove) represent three criteria. Two additional criteria are changes in heart rate and reduction in oxygen saturation. The remaining criteria are gestational week and behavioral status (active-awake, quiet-wake, active-asleep and quiet-sleeping). According to the scale, the highest score is 21 for prematures and 18 for term newborns. According to the scale scoring, 0-6 points indicate mild pain, 7-12 points moderate pain, and 13-21 points severe pain in a premature baby.
Measured: up to 7 days
Physiological Findings
Physiological Findings Follow-up Chart
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start16 May 2022
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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
- Model description
- This randomized controlled experimental study will performing to investigate the effect of smelling breast milk and listening to white noise in reducing pain during heel puncture
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Otlu, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444608
- Sponsor's protocol ID
- AnkaraU06BO
- Status last verified
- Nov 2023
- First submitted
- 29 Jun 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akcan E, Polat S. Comparative Effect of the Smells of Amniotic Fluid, Breast Milk, and Lavender on Newborns' Pain During Heel Lance. Breastfeed Med. 2016 Aug;11(6):309-314. doi: 10.1089/bfm.2015.0174. Epub 2016 Jun 17.
PubMed 27315487Alemdar DK. Effect of recorded maternal voice, breast milk odor, and incubator cover on pain and comfort during peripheral cannulation in preterm infants. Appl Nurs Res. 2018 Apr;40:1-6. doi: 10.1016/j.apnr.2017.12.001. Epub 2017 Dec 14.
PubMed 29579482American Academy of Pediatrics Committee on Fetus and Newborn; American Academy of Pediatrics Section on Surgery; Canadian Paediatric Society Fetus and Newborn Committee; Batton DG, Barrington KJ, Wallman C. Prevention and management of pain in the neonate: an update. Pediatrics. 2006 Nov;118(5):2231-41. doi: 10.1542/peds.2006-2277.
PubMed 17079598Baudesson de Chanville A, Brevaut-Malaty V, Garbi A, Tosello B, Baumstarck K, Gire C. Analgesic Effect of Maternal Human Milk Odor on Premature Neonates: A Randomized Controlled Trial. J Hum Lact. 2017 May;33(2):300-308. doi: 10.1177/0890334417693225. Epub 2017 Mar 27.
PubMed 28346843Brummelte S, Grunau RE, Chau V, Poskitt KJ, Brant R, Vinall J, Gover A, Synnes AR, Miller SP. Procedural pain and brain development in premature newborns. Ann Neurol. 2012 Mar;71(3):385-96. doi: 10.1002/ana.22267. Epub 2012 Feb 28.
PubMed 22374882Cakirli 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 33085532Cetinkaya S, Yavas Celik M, Ozdemir S. Effect of white noise on alleviating the pain of new-born during invasive procedures. J Matern Fetal Neonatal Med. 2022 Apr;35(8):1426-1432. doi: 10.1080/14767058.2020.1755652. Epub 2020 Apr 21.
PubMed 32316794Cignacco E, Hamers JP, Stoffel L, van Lingen RA, Gessler P, McDougall J, Nelle M. The efficacy of non-pharmacological interventions in the management of procedural pain in preterm and term neonates. A systematic literature review. Eur J Pain. 2007 Feb;11(2):139-52. doi: 10.1016/j.ejpain.2006.02.010. Epub 2006 Apr 3.
PubMed 16580851Doesburg SM, Chau CM, Cheung TPL, Moiseev A, Ribary U, Herdman AT, Miller SP, Cepeda IL, Synnes A, Grunau RE. Neonatal pain-related stress, functional cortical activity and visual-perceptual abilities in school-age children born at extremely low gestational age. Pain. 2013 Oct;154(10):1946-1952. doi: 10.1016/j.pain.2013.04.009. Epub 2013 Apr 8.
PubMed 23711638Dora O, Buyuk ET. RETRACTED: Effect of White Noise and Lullabies on Pain and Vital Signs in Invasive Interventions Applied to Premature Babies. Pain Manag Nurs. 2021 Dec;22(6):724-729. doi: 10.1016/j.pmn.2021.05.005. Epub 2021 Jun 28.
PubMed 34210600Grunau RE, Holsti L, Peters JW. Long-term consequences of pain in human neonates. Semin Fetal Neonatal Med. 2006 Aug;11(4):268-75. doi: 10.1016/j.siny.2006.02.007. Epub 2006 Apr 24.
PubMed 16632415Kahraman A, Gumus M, Akar M, Sipahi M, Bal Yilmaz H, Basbakkal Z. The effects of auditory interventions on pain and comfort in premature newborns in the neonatal intensive care unit; a randomised controlled trial. Intensive Crit Care Nurs. 2020 Dec;61:102904. doi: 10.1016/j.iccn.2020.102904. Epub 2020 Jul 9.
PubMed 32653359Kucuk 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 28414516Maayan-Metzger A, Kedem-Friedrich P, Bransburg Zabary S, Morag I, Hemi R, Kanety H, Strauss T. The Impact of Preterm Infants' Continuous Exposure to Breast Milk Odor on Stress Parameters: A Pilot Study. Breastfeed Med. 2018 Apr;13(3):211-214. doi: 10.1089/bfm.2017.0188. Epub 2018 Mar 12.
PubMed 29620936Rad ZA, Aziznejadroshan P, Amiri AS, Ahangar HG, Valizadehchari Z. The effect of inhaling mother's breast milk odor on the behavioral responses to pain caused by hepatitis B vaccine in preterm infants: a randomized clinical trial. BMC Pediatr. 2021 Feb 1;21(1):61. doi: 10.1186/s12887-021-02519-0.
PubMed 33522927
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Use of Breast Milk Odor and White Noise on Pain Management During Heel Lance in Premature Newborns: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05444608
- Acronym / sponsor ID
- AnkaraU06BO
- Conditions
- Pain
- Keywords
- Newborn, Pain, Breast milk odor, White noise, Heel lance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 6 Jul 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.
This study will conduct to evaluate the effect of using white noise and breast milk odor on pain during heel lance procedure in premature newborns. This study is a randomized controlled trial.
The study will conduct with premature newborns who were born between 34 and 37 weeks of gestation. The premature newborns will be divided into three groups by application of pain relief methods during heel lance to check blood sugar in newborns. These groups can be described as breast milk odor (n=22), white noise (n=22) and control group (n=22). The intervention will start 5 minutes before the procedure and last 5 minutes after the procedure. The infants will be recorded with a video camera by researcher before, during, and after the procedure. Premature Infant Pain Profile Revised (PIPP-R) will be used for pain grading.
Detailed description
The sense of pain develops in infants after the 20th gestational weeks with the initiation of communication between the cortex and the thalamus. Babies in the newborn period can respond physiologically, behaviorally and hormonal to painful stimuli which they experienced. Responses that emerge as a result of pain experience may adversely affect the current state of the newborn and its growth and development in the long term. One of the painful procedures that the newborn is frequently exposed to at the beginning of the extra-uterine life is blood collection from the heel. Pharmacological and non-pharmacological methods can be applied to alleviate the pain sensation experienced by newborns during these procedures. The existence of possible side effects of pharmacological methods has led to need to use non-pharmacological methods more effectively. In this study, it was aimed to investigate the effectiveness of breast milk odor and white noise, which are non-pharmacological methods, to the pain caused by heel puncture.
Main hypothesizes of the study can be listed as:
H11: Breast milk smelling during heel lancing in preterm newborn infants effectively reduces the infant's procedure-related pain.
H01: Breast milk smelling during heel lancing in preterm newborn infants is not effective in reducing the procedure-related pain of the infant.
H12: Listening to white noise during heel lancing in preterm newborn babies effectively reduces the baby's procedure-related pain.
H02: Listening to white noise during heel lancing in preterm newborn infants is not effective in reducing the procedure-related pain of the infant.
H13: Breast milk smelling during heel puncture in preterm newborn infants is more effective than white noise in reducing the procedure-related pain of the infant.
H03: Breast milk smelling during heel puncture in preterm newborn infants is not more effective than white noise in reducing the procedure-related pain of the infant.
H14: Listening to white noise during heel lancing in preterm newborn babies is more effective than breast milk odor in reducing the procedure-related pain of the baby.
H04: Listening to white noise during heel lancing in preterm newborn babies is not more effective than breast milk odor in reducing the procedure-related pain of the infant.
The population of the study will consist of preterm babies born between 34-37 weeks of gestation, who were hospitalized in the Neonatal Intensive Care Unit mother-baby room, and postnatal service of Ankara University Faculty of Medicine, Cebeci Application and Research Hospital, between May 2022 and October 2022 and for whom heel blood sampling is requested.The sample of the study will consist of 66 (white noise=22, breast milk odor=22, control=22) infants who met the case selection criteria and were randomly assigned to groups. Babies will be made to listen to white noise or smell breast milk for 5 minutes before the heel blood collection procedure, during the procedure and 5 minutes after the procedure in accordance with the group they are involved. Only routine nursing care will be applied to the control group, no additional intervention. All the infants in three different groups will be recorded by video camera. Recording will start 5 minutes before the heel lance procedure and continue during the procedure and 5 minutes after the procedure. Pain assessments will be made by another researcher through video recordings. Newborns pain will evaluate with the PIPP-R pain scale 5 minutes before procedure (at the beginnings of intervention), 2 minutes before procedure, at the time of the procedure and 5 minutes after the procedure. Heart rate and oxygen saturation will be recorded at the same times.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This randomized controlled experimental study will performing to investigate the effect of smelling breast milk and listening to white noise in reducing pain during heel puncture
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Data will be collected during heel blood sampling for blood sugar control from newborns randomly assigned to the control group. Babies in the control group will not be allowed to smell breast milk or listen to white noise.The newborn in the control group will continue to receive routine care.Camera recording will start 5 minutes before the procedure and lasting 5 minutes after the procedure. |
| Breast Milk Odor Group | Experimental | Behavioral: Breast milk olfactory stimulationData will be collected during heel blood sampling for blood sugar control from newborns randomly assigned to the breast milk odor group.Before the intervention, 2 ml of breast milk will be dripped into sterile sponge and the sponge will be placed within 3 cm of the newborn's nose.Babies in this group will start to smell their mother's milk 5 minutes before the procedure and will continue to smell for 5 minutes after the procedure.Camera recording will start 5 minutes before the procedure and lasting 5 minutes after the procedure. |
| White Noise Group | Experimental | Behavioral: White noise auditory stimulationData will be collected during heel blood sampling for blood sugar control from newborns randomly assigned to the white noise listening group.Before the intervention , a bluetooth speaker will be placed at the baby's feet. The speaker will be connected to the phone and the sound level will be adjusted to 50 decibels by means of a decibel meter. The baby will be started to listen to white noise 5 minutes before the procedure.Camera recording will start 5 minutes before the procedure and lasting 5 minutes after the procedure. |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- gestational age between 34 and 37 weeks
- birth weight over 1500 g
- Taking blood from the heel for the purpose of measuring blood sugar
- Starting feeding with breast milk
- Parental consent
Key exclusion criteria (8 listed)
- Having a chromosomal abnormality
- Presence of neonatal seizures
- Presence of intracranial bleeding (grade III-IV)
- Presence of craniofacial malformation
- Presence of congenital hearing loss
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 |
|---|---|---|
| Breast milk olfactory stimulationBefore the intervention, 2 ml of breast milk will be dripped into sterile sponge and the sponge will be placed within 3 cm of the newborn's nose.Babies in this group will start to smell their mother's milk 5 minutes before the procedure and will continue to smell for 5 minutes after the procedure. | Behavioural | Breast Milk Odor Group |
| White noise auditory stimulationBefore the intervention, a bluetooth speaker will be placed at the baby's feet. The speaker will be connected to the phone and the sound level will be adjusted to 50 decibels by means of a decibel meter. The baby will be started to listen to white noise 5 minutes before the procedure and will continue to listen for 5 minutes after the procedure. | Behavioural | White Noise Group |
Primary outcome
Neonatal Pain
Time frame: up to 7 days
Premature Infant Pain Profile-Revised The scale includes seven criteria. Facial expressions (frown, squint, prominence of the nasolabial groove) represent three criteria. Two additional criteria are changes in heart rate and reduction in oxygen saturation. The remaining criteria are gestational week and behavioral status (active-awake, quiet-wake, active-asleep and quiet-sleeping). According to the scale, the highest score is 21 for prematures and 18 for term newborns. According to the scale scoring, 0-6 points indicate mild pain, 7-12 points moderate pain, and 13-21 points severe pain in a premature baby.
Physiological Findings
Time frame: up to 7 days
Physiological Findings Follow-up Chart
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 22 Nov 2023.
- Background: PubMed 27315487Akcan E, Polat S. Comparative Effect of the Smells of Amniotic Fluid, Breast Milk, and Lavender on Newborns' Pain During Heel Lance. Breastfeed Med. 2016 Aug;11(6):309-314. doi: 10.1089/bfm.2015.0174. Epub 2016 Jun 17.
- Background: PubMed 29579482Alemdar DK. Effect of recorded maternal voice, breast milk odor, and incubator cover on pain and comfort during peripheral cannulation in preterm infants. Appl Nurs Res. 2018 Apr;40:1-6. doi: 10.1016/j.apnr.2017.12.001. Epub 2017 Dec 14.
- Background: PubMed 17079598American Academy of Pediatrics Committee on Fetus and Newborn; American Academy of Pediatrics Section on Surgery; Canadian Paediatric Society Fetus and Newborn Committee; Batton DG, Barrington KJ, Wallman C. Prevention and management of pain in the neonate: an update. Pediatrics. 2006 Nov;118(5):2231-41. doi: 10.1542/peds.2006-2277.
- Background: PubMed 28346843Baudesson de Chanville A, Brevaut-Malaty V, Garbi A, Tosello B, Baumstarck K, Gire C. Analgesic Effect of Maternal Human Milk Odor on Premature Neonates: A Randomized Controlled Trial. J Hum Lact. 2017 May;33(2):300-308. doi: 10.1177/0890334417693225. Epub 2017 Mar 27.
- Background: PubMed 22374882Brummelte S, Grunau RE, Chau V, Poskitt KJ, Brant R, Vinall J, Gover A, Synnes AR, Miller SP. Procedural pain and brain development in premature newborns. Ann Neurol. 2012 Mar;71(3):385-96. doi: 10.1002/ana.22267. Epub 2012 Feb 28.
- 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 32316794Cetinkaya S, Yavas Celik M, Ozdemir S. Effect of white noise on alleviating the pain of new-born during invasive procedures. J Matern Fetal Neonatal Med. 2022 Apr;35(8):1426-1432. doi: 10.1080/14767058.2020.1755652. Epub 2020 Apr 21.
- Background: PubMed 16580851Cignacco E, Hamers JP, Stoffel L, van Lingen RA, Gessler P, McDougall J, Nelle M. The efficacy of non-pharmacological interventions in the management of procedural pain in preterm and term neonates. A systematic literature review. Eur J Pain. 2007 Feb;11(2):139-52. doi: 10.1016/j.ejpain.2006.02.010. Epub 2006 Apr 3.
- Background: PubMed 23711638Doesburg SM, Chau CM, Cheung TPL, Moiseev A, Ribary U, Herdman AT, Miller SP, Cepeda IL, Synnes A, Grunau RE. Neonatal pain-related stress, functional cortical activity and visual-perceptual abilities in school-age children born at extremely low gestational age. Pain. 2013 Oct;154(10):1946-1952. doi: 10.1016/j.pain.2013.04.009. Epub 2013 Apr 8.
- Background: PubMed 34210600Dora O, Buyuk ET. RETRACTED: Effect of White Noise and Lullabies on Pain and Vital Signs in Invasive Interventions Applied to Premature Babies. Pain Manag Nurs. 2021 Dec;22(6):724-729. doi: 10.1016/j.pmn.2021.05.005. Epub 2021 Jun 28.
- Background: PubMed 16632415Grunau RE, Holsti L, Peters JW. Long-term consequences of pain in human neonates. Semin Fetal Neonatal Med. 2006 Aug;11(4):268-75. doi: 10.1016/j.siny.2006.02.007. Epub 2006 Apr 24.
- Background: PubMed 32653359Kahraman A, Gumus M, Akar M, Sipahi M, Bal Yilmaz H, Basbakkal Z. The effects of auditory interventions on pain and comfort in premature newborns in the neonatal intensive care unit; a randomised controlled trial. Intensive Crit Care Nurs. 2020 Dec;61:102904. doi: 10.1016/j.iccn.2020.102904. Epub 2020 Jul 9.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast milk olfactory stimulation and White noise auditory stimulation in people with Pain, run by Ankara 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 5 inclusion and 8 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 22 Nov 2023. 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?
Neonatal Pain (time frame: up to 7 days). 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 NCT05444608, which also lists 19 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 22 Nov 2023.