Neonatal Pain Management and Pain Monitoring Using New Methods
NCT ID: NCT04967118
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2023-05-02
2024-12-31
Brief Summary
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The effectiveness of interventions will be assessed using validated pain scales (PIPP-R and NIAPAS), changes in sensory cortex activation (near-infrared spectroscopy, NIRS) and changes in physiological indicators (oxygen saturation, heart rate, respiratory rate). The secondary objectives will include evaluating the effectiveness of interventions in relation to infant recovery and evaluating the use of NIRS monitoring in relation to neonatal pain assessment scales.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Skin-to-skin contact
Neonates will be placed ventral skin-to-skin position with their mother at least thirty minutes prior the heel lance to give time to calm down following transfer. Skin-to-skin positioning will be taken account comfortable position as possible for mother and the baby, easy to access heel for blood sample and interference minimizing during video recording and continuous NIRS, ECG and oxygen saturation measurement. Skin-to-skin contact will be continued for approximately fifteen minutes after completion of blood sampling. In addition, the neonates will be given a 30% oral glucose solution two minutes prior the heel lance.
Skin-to-skin contact
Diaper clad baby will be placed ventral position on bare chest of mother 30 minute prior to the heel lance
Mother's heartbeats as sound and vibration
Neonates will be placed in an incubator or a cot, depending on their gestational age, and will be supported on side position by nest-shaped rolls according to department's normal practice. The platform on which the mother's heartbeat will be played will be placed under mattress of the incubator or crib. The playing of the mother's recorded heartbeats will be started thirty minutes prior the heel lance and will be continued during and fifteen minutes after the blood sampling. In addition, the neonates will be given a 30% oral glucose solution two minutes prior the heel lance.
Mother's heartbeats as sound and vibration
The mother's heartbeat will be recorded and the heartbeat sounds will be saved to the platform. The platform will be placed under the infant's mattress and the heartbeat will be started 30 minute prior to the heel lance.
30% oral glucose
Neonates will be placed on in an incubator or a cot, depending on their gestational age, and will be supported on side position by nest-shaped rolls according to department's normal practice. The neonates will be given a 30% oral glucose solution two minutes prior the heel lance
30% oral glucose
The infant will be given 30% oral glucose solution 2 minutes before the injection
Interventions
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Skin-to-skin contact
Diaper clad baby will be placed ventral position on bare chest of mother 30 minute prior to the heel lance
Mother's heartbeats as sound and vibration
The mother's heartbeat will be recorded and the heartbeat sounds will be saved to the platform. The platform will be placed under the infant's mattress and the heartbeat will be started 30 minute prior to the heel lance.
30% oral glucose
The infant will be given 30% oral glucose solution 2 minutes before the injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admitted to NICU
* Parents are able to read, write and speak Finnish
Exclusion Criteria
* Apgar points were 6 or less at 5 minutes of age
* Has been found grade III or IV cerebral haemorrhage
* Major congenital anomalies
* Has intubated or receiving a nCPAP
* Has received analgesics or sedatives for less than 24 hours prior to the study
32 Weeks
42 Weeks
ALL
No
Sponsors
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University of Oulu
OTHER
Responsible Party
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Anna-Kaija Palomaa
PhD researcher
Locations
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Oulu University Hospita
Oulu, , Finland
Countries
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Central Contacts
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Facility Contacts
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Anna-Kaija Palomaa
Role: primary
Tarja Pölkki, profesor
Role: backup
Other Identifiers
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296/2018
Identifier Type: -
Identifier Source: org_study_id