Clinical trial NCT06609252: Breast Milk Odour and Mother's Voice on Pain and Comfort
Official title: The Effect of Breast Milk Odour and Mother's Voice on Pain and Comfort During Retinopathy Examination in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Breast Milk Odour
Comfort
Keywords: pain
breast milk odour
comfort
Lead sponsor: Tarsus University
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 66
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: pain level
timeFrame: 1 hour
measure: stress level
timeFrame: 1 hour
measure: comfort level
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Tarsus
country: Turkey
facility: Tarsus University
Study officials:
References:
citation: 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.
citation: Fajolu 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.
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citation: Dilli 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.
citation: Jang 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.
citation: Liao, 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).