PainNCT06609252
Breast Milk Odour and Mother's Voice on Pain and Comfort
A study testing Breast milk odour and Mother voice in people with Pain and Breast Milk Odour, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted to examine the effect of breast milk smell and mother's voice on pain and comfort in retinopathy examination in premature infants. The sample of the study will consist of premature infants who are receiving treatment and care in Izmir Provincial Health Directorate Izmir City Hospital… Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Pain, Breast Milk Odour, Comfort
- What is being tested?
- Breast milk odour and Mother voice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Sep 2024to 11 Apr 2025
- 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 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent's infant agreeing to participate in the study
- The baby is being treated and monitored in the Neonatal Intensive Care Unit
- The mother has milk
- Gestational age ≤32 weeks
- Birth weight ≤2000 grams
- Babies who will be examined for ROP for the first time
Who cannot join
- Gestational age of 33> weeks
- No need for mechanical ventilator support,
- Hearing sensory loss diagnosis
- Administration of sedative, analgesic and anticonvulsant drugs before the examination
- Having a neurological problem (e.g. asphyxia, hypoxic ischaemic encephalopathy, intraventricular
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breast Milk Odour and Mother's Voice on Pain and Comfort During Retinopathy Examination in Premature Infants
This study will be conducted to examine the effect of breast milk smell and mother's voice on pain and comfort in retinopathy examination in premature infants. The sample of the study will consist of premature infants who are receiving treatment and care in Izmir Provincial Health Directorate Izmir City Hospital Neonatal Intensive Care Unit within the central borders of Izmir province and who comply with the research limitations to be examined for ROP.
Stage 1: The research will start after the ethics committee and institutional permissions are obtained. The group in which the babies will be included will be determined by randomisation method. In the clinic where the research is carried out, ROP examination is performed on a certain day of the week, so the families of premature babies who meet the inclusion criteria will be informed about the research and their verbal and written permissions will be obtained.
Read more
Stage 2: On the day of the examination, fresh breast milk will be obtained from the mothers of the babies in the breast milk group. Mothers of premature infants in the mother voice group will be asked to make a voice recording before the examination. 'Introductory Information Form' will be filled out before the procedure.
Stage 3: Video recording will be made to evaluate the pain, stress, comfort and physiological parameters of premature babies. Video recording will be started 2 minutes before the examination. Video recording will continue for 5 minutes after the ROP examination.
Stage 4: Breast milk odour, mother's voice and physiological parameters of the babies in the control group will be recorded 2 minutes before the examination, 2 minutes after the end of the examination and 5 minutes after the end of the examination.
Stage 5: The babies in the breast milk odour group will be made to smell the styrene sponge dripped with their own mother's milk 2 minutes before the procedure.
Stage 6: Babies in the mother's voice group will be made to listen to their own mother's voice 2 minutes before the procedure.
7th Stage: Babies in the control group will be subjected to the routine practice of the clinic.
Stage 8: The videos recorded after the interventions and the scores given to the PIPP, CEQ, and PBQ scales will be evaluated by two independent faculty members who are experts in their fields.
Read the detailed description
The use of effective and efficient non-pharmacological methods to reduce the pain and stress experienced by premature babies due to retinopathy examination and to increase their comfort has an important place in supporting optimal growth and development. This study was planned to reveal the effectiveness of different non-pharmacological methods during the examination performed within the scope of the screening programme for prematurity.
This study will be conducted to examine the effect of breast milk smell and mother's voice on pain and comfort in retinopathy examination in premature infants. The sample of the study will consist of premature infants who are receiving treatment and care in Izmir Provincial Health Directorate Izmir City Hospital Neonatal Intensive Care Unit within the central borders of Izmir province and who comply with the research limitations to be examined for ROP.
Data Collection Breast milk odour group: On the day of the study, the mothers of the babies will be contacted and fresh breast milk will be obtained from the mother of each baby. In the study, a sterile sponge will be used to smell the breast milk to the baby. Breast milk will be taken as 2 ml, dripped onto a sterile sponge and held 10 cm away from the baby's nose and sniffed 2 minutes before the examination.
Mother voice group: Mothers of premature babies in the mother voice group will be given a voice recorder on the day of the study and will be encouraged to express their feelings and thoughts and say what they want to say to their babies and will be asked to talk to their babies as they wish. The mother's voice, which is recorded 2 minutes before the procedure, will be placed approximately 30 cm away from the baby's ear and a loudspeaker will be placed at the foot end so that the baby can listen to the sound. The American Academy of Paediatrics recommends a sound level of 45-50 dB for premature babies. Therefore, the sound level will be measured with a decibel meter and set to 50 dB.
Control group: In the guideline prepared jointly by the Turkish Neonatology Association and the Turkish Society of Ophthalmology in 2021, it is recommended that the baby should be held by a nurse in such a way that the baby's head and arms are fixed, and the baby's hands and feet should be gently flexed or loosely swaddled during the retinopathy examination. Within the routine practice of the clinic, the babies in the control group are held.
Stage 1: The research will start after the ethics committee and institutional permissions are obtained. The group in which the babies will be included will be determined by randomisation method. In the clinic where the research is carried out, ROP examination is performed on a certain day of the week, so the families of premature babies who meet the inclusion criteria will be informed about the research and their verbal and written permissions will be obtained.
Stage 2: On the day of the examination, fresh breast milk will be obtained from the mothers of the babies in the breast milk group. Mothers of premature infants in the mother voice group will be asked to make a voice recording before the examination. 'Introductory Information Form' will be filled out before the procedure.
Stage 3: Video recording will be made to evaluate the pain, stress, comfort and physiological parameters of premature babies. Video recording will be started 2 minutes before the examination. Video recording will continue for 5 minutes after the ROP examination.
Stage 4: Breast milk odour, mother's voice and physiological parameters of the babies in the control group will be recorded 2 minutes before the examination, 2 minutes after the end of the examination and 5 minutes after the end of the examination.
Stage 5: The babies in the breast milk odour group will be made to smell the styrene sponge dripped with their own mother's milk 2 minutes before the procedure.
Stage 6: Babies in the mother's voice group will be made to listen to their own mother's voice 2 minutes before the procedure.
7th Stage: Babies in the control group will be subjected to the routine practice of the clinic.
Stage 8: The videos recorded after the interventions and the scores given to the PIPP, CEQ, and PBQ scales will be evaluated by two independent faculty members who are experts in their fields.
- Conditions
- Pain, Breast Milk Odour, Comfort
- Being tested
- Breast milk odour, Mother voice
- Keywords
- pain, breast milk odour, comfort
- 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 odourOther
On the day of the study, the mothers of the babies will be contacted and fresh breast milk will be obtained from the mother of each baby. In the study, a sterile sponge will be used to smell the breast milk to the baby. Breast milk will be taken as 2 ml, dripped onto a sterile sponge and held 10 cm away from the baby's nose and sniffed 2 minutes before the examination.
Mother voiceOther
Mothers of premature babies in the mother voice group will be given a voice recorder on the day of the study and will be encouraged to express their feelings and thoughts and say what they want to say to their babies and will be asked to talk to their babies as they wish. The mother's voice, which is recorded 2 minutes before the procedure, will be placed approximately 30 cm away from the baby's ear and a loudspeaker will be placed at the foot end so that the baby can listen to the sound.
| Study group | Role | What they receive |
|---|---|---|
| breast milk smell | Experimental | On the day of the study, the mothers of the babies will be contacted and fresh breast milk will be obtained from the mother of each baby. In the study, a sterile sponge will be used to smell the breast milk to the baby. Breast milk will be taken as 2 ml, dripped onto a sterile sponge and held 10 cm away from the baby's nose and sniffed 2 minutes before the examination. Receives: Other: Breast milk odour |
| mother's voice | Experimental | Mothers of premature babies in the mother voice group will be given a voice recorder on the day of the study and will be encouraged to express their feelings and thoughts and say what they want to say to their babies and will be asked to talk to their babies as they wish. The mother's voice, which is recorded 2 minutes before the procedure, will be placed approximately 30 cm away from the baby's ear and a loudspeaker will be placed at the foot end so that the baby can listen to the sound. The American Academy of Paediatrics recommends a sound level of 45-50 dB for premature babies. Therefore, the sound level will be measured with a decibel meter and set to 50 dB. Receives: Other: Mother voice |
| control | No intervention | In the guideline prepared jointly by the Turkish Neonatology Association and the Turkish Society of Ophthalmology in 2021, it is recommended that the baby should be held by a nurse in such a way that the baby's head and arms are fixed, and the baby's hands and feet should be gently flexed or loosely swaddled during the retinopathy examination. Within the routine practice of the clinic, the babies in the control group are held. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain level
Premature Newborn Pain Profile It is a pain diagnostic scale developed by Stevens et al. It was revised by Gibbins et al. for premature infants at 26-37 gestation weeks. Turkish validity and reliability was performed by Akcan and Yiğit in 2015. Statements including 7 items such as gestational age, behavioural status, highest heart rate value, lowest oxygen saturation value, forehead wrinkling, squinting and widening of the wings of the nose are questioned. Each item is scored as 0, 1, 2, 3 from good to bad. The baby's pain is calculated over the total score. The highest score is 21 and the lowest score is 0. If the pain is mild, it is evaluated by scoring between 0-6 points, moderate severity between 7-12 points, and severe between 13-21 points.
Measured: 1 hour
stress level
Neonatal Stress Scale It was developed by Ceylan and Bolışık to evaluate stress in premature infants and its validity and reliability were performed. The scale is a three-point Likert-type scale and consists of 24 items and 8 sub-dimensions. The scale consists of 'facial expression', 'body colour', 'respiration', 'activity level', 'comfortability', 'muscle tone', 'excursions' and 'posture' sub-dimensions. Each subgroup in the scale is scored between 0-2 points. The minimum score that can be obtained from the scale is 0 and the maximum score is 16. An increase in the score indicates an increase in the infant's stress. The evaluation of the scale is done through observation
Measured: 1 hour
comfort level
Premature Infant Comfort Scale Alemdar and Tüfekçi adapted this scale, which was developed by Caljouw et al. in 2007 for premature infants, into Turkish and stated that it evaluates 7 parameters such as 'Alertness, Calmness / Agitation, Respiratory Status (only in mechanical ventilation support) or Crying (not evaluated because it was scored only in children with spontaneous breathing), Physical Movement, Muscle Tone, Facial Movements and Mean Heart Rate.' Each condition is scored from 1 to 5, ranging from good to bad, with 35 being the lowest and 7 being the highest comfort score.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start17 Sep 2024
- Primary completion11 Mar 2025
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atiye Karakul, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609252
- Sponsor's protocol ID
- 2024/74
- Status last verified
- Apr 2025
- First submitted
- 20 Sep 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yue W, Han X, Luo J, Zeng Z, Yang M. Effect of music therapy on preterm infants in neonatal intensive care unit: Systematic review and meta-analysis of randomized controlled trials. J Adv Nurs. 2021 Feb;77(2):635-652. doi: 10.1111/jan.14630. Epub 2020 Nov 17.
PubMed 33200833Fajolu IB, Dedeke IOF, Ezenwa BN, Ezeaka VC. Non-pharmacological pain relief interventions in preterm neonates undergoing screening for retinopathy of prematurity: a systematic review. BMJ Open Ophthalmol. 2023 Dec 6;8(1):e001271. doi: 10.1136/bmjophth-2023-001271.
PubMed 38057104Valeri BO, Holsti L, Linhares MB. Neonatal pain and developmental outcomes in children born preterm: a systematic review. Clin J Pain. 2015 Apr;31(4):355-62. doi: 10.1097/AJP.0000000000000114.
PubMed 24866853Asadollahi M, Jabraeili M, Mahallei M, Asgari Jafarabadi M, Ebrahimi S. Effects of Gentle Human Touch and Field Massage on Urine Cortisol Level in Premature Infants: A Randomized, Controlled Clinical Trial. J Caring Sci. 2016 Sep 1;5(3):187-194. doi: 10.15171/jcs.2016.020. eCollection 2016 Sep.
PubMed 27752484Dilli D, Ilarslan NE, Kabatas EU, Zenciroglu A, Simsek Y, Okumus N. Oral sucrose and non-nutritive sucking goes some way to reducing pain during retinopathy of prematurity eye examinations. Acta Paediatr. 2014 Feb;103(2):e76-9. doi: 10.1111/apa.12454. Epub 2013 Nov 11.
PubMed 24730361Jang EK, Lee H, Jo KS, Lee SM, Seo HJ, Huh EJ. Comparison of the Pain-relieving Effects of Human Milk, Sucrose, and Distilled Water during Examinations for Retinopathy of Prematurity: A Randomized Controlled Trial. Child Health Nurs Res. 2019 Jul;25(3):255-261. doi: 10.4094/chnr.2019.25.3.255. Epub 2019 Jul 31.
PubMed 35004418Liao, W. H., Xu, H. Y., Zhou, X., Tian, J. L., Fang, X. Y., Ding, J., … Wu, H. L. (2019). Non-nutritive sucking and nesting greatly reduces pain during retinopathy screening in premature infants. Hong Kong Journal of Paediatrics, 24(3).
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breast Milk Odour and Mother's Voice on Pain and Comfort During Retinopathy Examination in Premature Infants
- ClinicalTrials.gov ID
- NCT06609252
- Acronym / sponsor ID
- 2024/74
- Conditions
- Pain, Breast Milk Odour, Comfort
- Keywords
- pain, breast milk odour, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 24 Sep 2024 (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 be conducted to examine the effect of breast milk smell and mother's voice on pain and comfort in retinopathy examination in premature infants. The sample of the study will consist of premature infants who are receiving treatment and care in Izmir Provincial Health Directorate Izmir City Hospital Neonatal Intensive Care Unit within the central borders of Izmir province and who comply with the research limitations to be examined for ROP.
Stage 1: The research will start after the ethics committee and institutional permissions are obtained. The group in which the babies will be included will be determined by randomisation method. In the clinic where the research is carried out, ROP examination is performed on a certain day of the week, so the families of premature babies who meet the inclusion criteria will be informed about the research and their verbal and written permissions will be obtained.
Stage 2: On the day of the examination, fresh breast milk will be obtained from the mothers of the babies in the breast milk group. Mothers of premature infants in the mother voice group will be asked to make a voice recording before the examination. 'Introductory Information Form' will be filled out before the procedure.
Stage 3: Video recording will be made to evaluate the pain, stress, comfort and physiological parameters of premature babies. Video recording will be started 2 minutes before the examination. Video recording will continue for 5 minutes after the ROP examination.
Stage 4: Breast milk odour, mother's voice and physiological parameters of the babies in the control group will be recorded 2 minutes before the examination, 2 minutes after the end of the examination and 5 minutes after the end of the examination.
Stage 5: The babies in the breast milk odour group will be made to smell the styrene sponge dripped with their own mother's milk 2 minutes before the procedure.
Stage 6: Babies in the mother's voice group will be made to listen to their own mother's voice 2 minutes before the procedure.
7th Stage: Babies in the control group will be subjected to the routine practice of the clinic.
Stage 8: The videos recorded after the interventions and the scores given to the PIPP, CEQ, and PBQ scales will be evaluated by two independent faculty members who are experts in their fields.
Detailed description
The use of effective and efficient non-pharmacological methods to reduce the pain and stress experienced by premature babies due to retinopathy examination and to increase their comfort has an important place in supporting optimal growth and development. This study was planned to reveal the effectiveness of different non-pharmacological methods during the examination performed within the scope of the screening programme for prematurity.
This study will be conducted to examine the effect of breast milk smell and mother's voice on pain and comfort in retinopathy examination in premature infants. The sample of the study will consist of premature infants who are receiving treatment and care in Izmir Provincial Health Directorate Izmir City Hospital Neonatal Intensive Care Unit within the central borders of Izmir province and who comply with the research limitations to be examined for ROP.
Data Collection Breast milk odour group: On the day of the study, the mothers of the babies will be contacted and fresh breast milk will be obtained from the mother of each baby. In the study, a sterile sponge will be used to smell the breast milk to the baby. Breast milk will be taken as 2 ml, dripped onto a sterile sponge and held 10 cm away from the baby's nose and sniffed 2 minutes before the examination.
Mother voice group: Mothers of premature babies in the mother voice group will be given a voice recorder on the day of the study and will be encouraged to express their feelings and thoughts and say what they want to say to their babies and will be asked to talk to their babies as they wish. The mother's voice, which is recorded 2 minutes before the procedure, will be placed approximately 30 cm away from the baby's ear and a loudspeaker will be placed at the foot end so that the baby can listen to the sound. The American Academy of Paediatrics recommends a sound level of 45-50 dB for premature babies. Therefore, the sound level will be measured with a decibel meter and set to 50 dB.
Control group: In the guideline prepared jointly by the Turkish Neonatology Association and the Turkish Society of Ophthalmology in 2021, it is recommended that the baby should be held by a nurse in such a way that the baby's head and arms are fixed, and the baby's hands and feet should be gently flexed or loosely swaddled during the retinopathy examination. Within the routine practice of the clinic, the babies in the control group are held.
Stage 1: The research will start after the ethics committee and institutional permissions are obtained. The group in which the babies will be included will be determined by randomisation method. In the clinic where the research is carried out, ROP examination is performed on a certain day of the week, so the families of premature babies who meet the inclusion criteria will be informed about the research and their verbal and written permissions will be obtained.
Stage 2: On the day of the examination, fresh breast milk will be obtained from the mothers of the babies in the breast milk group. Mothers of premature infants in the mother voice group will be asked to make a voice recording before the examination. 'Introductory Information Form' will be filled out before the procedure.
Stage 3: Video recording will be made to evaluate the pain, stress, comfort and physiological parameters of premature babies. Video recording will be started 2 minutes before the examination. Video recording will continue for 5 minutes after the ROP examination.
Stage 4: Breast milk odour, mother's voice and physiological parameters of the babies in the control group will be recorded 2 minutes before the examination, 2 minutes after the end of the examination and 5 minutes after the end of the examination.
Stage 5: The babies in the breast milk odour group will be made to smell the styrene sponge dripped with their own mother's milk 2 minutes before the procedure.
Stage 6: Babies in the mother's voice group will be made to listen to their own mother's voice 2 minutes before the procedure.
7th Stage: Babies in the control group will be subjected to the routine practice of the clinic.
Stage 8: The videos recorded after the interventions and the scores given to the PIPP, CEQ, and PBQ scales will be evaluated by two independent faculty members who are experts in their fields.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| breast milk smell | Experimental | Other: Breast milk odourOn the day of the study, the mothers of the babies will be contacted and fresh breast milk will be obtained from the mother of each baby. In the study, a sterile sponge will be used to smell the breast milk to the baby. Breast milk will be taken as 2 ml, dripped onto a sterile sponge and held 10 cm away from the baby's nose and sniffed 2 minutes before the examination. |
| mother's voice | Experimental | Other: Mother voiceMothers of premature babies in the mother voice group will be given a voice recorder on the day of the study and will be encouraged to express their feelings and thoughts and say what they want to say to their babies and will be asked to talk to their babies as they wish. The mother's voice, which is recorded 2 minutes before the procedure, will be placed approximately 30 cm away from the baby's ear and a loudspeaker will be placed at the foot end so that the baby can listen to the sound. The American Academy of Paediatrics recommends a sound level of 45-50 dB for premature babies. Therefore, the sound level will be measured with a decibel meter and set to 50 dB. |
| control | No intervention | –In the guideline prepared jointly by the Turkish Neonatology Association and the Turkish Society of Ophthalmology in 2021, it is recommended that the baby should be held by a nurse in such a way that the baby's head and arms are fixed, and the baby's hands and feet should be gently flexed or loosely swaddled during the retinopathy examination. Within the routine practice of the clinic, the babies in the control group are held. |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Parent's infant agreeing to participate in the study
- The baby is being treated and monitored in the Neonatal Intensive Care Unit
- The mother has milk
- Gestational age ≤32 weeks
- Birth weight ≤2000 grams
Key exclusion criteria (5 listed)
- Gestational age of 33> weeks
- No need for mechanical ventilator support,
- Hearing sensory loss diagnosis
- Administration of sedative, analgesic and anticonvulsant drugs before the examination
- Having a neurological problem (e.g. asphyxia, hypoxic ischaemic encephalopathy, intraventricular
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 odourOn the day of the study, the mothers of the babies will be contacted and fresh breast milk will be obtained from the mother of each baby. In the study, a sterile sponge will be used to smell the breast milk to the baby. Breast milk will be taken as 2 ml, dripped onto a sterile sponge and held 10 cm away from the baby's nose and sniffed 2 minutes before the examination. | Other | breast milk smell |
| Mother voiceMothers of premature babies in the mother voice group will be given a voice recorder on the day of the study and will be encouraged to express their feelings and thoughts and say what they want to say to their babies and will be asked to talk to their babies as they wish. The mother's voice, which is recorded 2 minutes before the procedure, will be placed approximately 30 cm away from the baby's ear and a loudspeaker will be placed at the foot end so that the baby can listen to the sound. | Other | mother's voice |
Primary outcome
pain level
Time frame: 1 hour
Premature Newborn Pain Profile It is a pain diagnostic scale developed by Stevens et al. It was revised by Gibbins et al. for premature infants at 26-37 gestation weeks. Turkish validity and reliability was performed by Akcan and Yiğit in 2015. Statements including 7 items such as gestational age, behavioural status, highest heart rate value, lowest oxygen saturation value, forehead wrinkling, squinting and widening of the wings of the nose are questioned. Each item is scored as 0, 1, 2, 3 from good to bad. The baby's pain is calculated over the total score. The highest score is 21 and the lowest score is 0. If the pain is mild, it is evaluated by scoring between 0-6 points, moderate severity between 7-12 points, and severe between 13-21 points.
stress level
Time frame: 1 hour
Neonatal Stress Scale It was developed by Ceylan and Bolışık to evaluate stress in premature infants and its validity and reliability were performed. The scale is a three-point Likert-type scale and consists of 24 items and 8 sub-dimensions. The scale consists of 'facial expression', 'body colour', 'respiration', 'activity level', 'comfortability', 'muscle tone', 'excursions' and 'posture' sub-dimensions. Each subgroup in the scale is scored between 0-2 points. The minimum score that can be obtained from the scale is 0 and the maximum score is 16. An increase in the score indicates an increase in the infant's stress. The evaluation of the scale is done through observation
comfort level
Time frame: 1 hour
Premature Infant Comfort Scale Alemdar and Tüfekçi adapted this scale, which was developed by Caljouw et al. in 2007 for premature infants, into Turkish and stated that it evaluates 7 parameters such as 'Alertness, Calmness / Agitation, Respiratory Status (only in mechanical ventilation support) or Crying (not evaluated because it was scored only in children with spontaneous breathing), Physical Movement, Muscle Tone, Facial Movements and Mean Heart Rate.' Each condition is scored from 1 to 5, ranging from good to bad, with 35 being the lowest and 7 being the highest comfort score.
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 15 Apr 2025.
- Background: PubMed 33200833Yue W, Han X, Luo J, Zeng Z, Yang M. Effect of music therapy on preterm infants in neonatal intensive care unit: Systematic review and meta-analysis of randomized controlled trials. J Adv Nurs. 2021 Feb;77(2):635-652. doi: 10.1111/jan.14630. Epub 2020 Nov 17.
- Background: PubMed 38057104Fajolu IB, Dedeke IOF, Ezenwa BN, Ezeaka VC. Non-pharmacological pain relief interventions in preterm neonates undergoing screening for retinopathy of prematurity: a systematic review. BMJ Open Ophthalmol. 2023 Dec 6;8(1):e001271. doi: 10.1136/bmjophth-2023-001271.
- Background: PubMed 24866853Valeri BO, Holsti L, Linhares MB. Neonatal pain and developmental outcomes in children born preterm: a systematic review. Clin J Pain. 2015 Apr;31(4):355-62. doi: 10.1097/AJP.0000000000000114.
- Background: PubMed 27752484Asadollahi M, Jabraeili M, Mahallei M, Asgari Jafarabadi M, Ebrahimi S. Effects of Gentle Human Touch and Field Massage on Urine Cortisol Level in Premature Infants: A Randomized, Controlled Clinical Trial. J Caring Sci. 2016 Sep 1;5(3):187-194. doi: 10.15171/jcs.2016.020. eCollection 2016 Sep.
- Background: PubMed 24730361Dilli D, Ilarslan NE, Kabatas EU, Zenciroglu A, Simsek Y, Okumus N. Oral sucrose and non-nutritive sucking goes some way to reducing pain during retinopathy of prematurity eye examinations. Acta Paediatr. 2014 Feb;103(2):e76-9. doi: 10.1111/apa.12454. Epub 2013 Nov 11.
- Background: PubMed 35004418Jang EK, Lee H, Jo KS, Lee SM, Seo HJ, Huh EJ. Comparison of the Pain-relieving Effects of Human Milk, Sucrose, and Distilled Water during Examinations for Retinopathy of Prematurity: A Randomized Controlled Trial. Child Health Nurs Res. 2019 Jul;25(3):255-261. doi: 10.4094/chnr.2019.25.3.255. Epub 2019 Jul 31.
- BackgroundLiao, W. H., Xu, H. Y., Zhou, X., Tian, J. L., Fang, X. Y., Ding, J., … Wu, H. L. (2019). Non-nutritive sucking and nesting greatly reduces pain during retinopathy screening in premature infants. Hong Kong Journal of Paediatrics, 24(3).
- 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. 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 odour and Mother voice in people with Pain and Breast Milk Odour, run by Tarsus 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 6 inclusion and 5 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 15 Apr 2025. 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?
pain level (time frame: 1 hour). The study lists 3 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 NCT06609252, which also lists 7 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 15 Apr 2025.