Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609252
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Breast Milk Odour and Mothers Voice on Pain and Comfort
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Breast Milk Odour and Mothers Voice on Pain and Comfort During Retinopathy Examination in Premature Infants
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be conducted to examine the effect of breast milk smell and mothers 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 mothers 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 mothers milk 2 minutes before the procedure
Stage 6 Babies in the mothers voice group will be made to listen to their own mothers 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
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 mothers 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 mothers milk 2 minutes before the procedure
Stage 6 Babies in the mothers voice group will be made to listen to their own mothers 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 mothers 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 babys 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 mothers voice which is recorded 2 minutes before the procedure will be placed approximately 30 cm away from the babys 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 babys head and arms are fixed and the babys 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 mothers 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 mothers milk 2 minutes before the procedure
Stage 6 Babies in the mothers voice group will be made to listen to their own mothers 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
This study will be conducted to examine the effect of breast milk smell and mothers 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 babys 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 mothers voice which is recorded 2 minutes before the procedure will be placed approximately 30 cm away from the babys 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 babys head and arms are fixed and the babys 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 mothers 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 mothers milk 2 minutes before the procedure
Stage 6 Babies in the mothers voice group will be made to listen to their own mothers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None