An observational study in Acute Pain, Pain, Procedural and Agitation, sponsored by Newcastle University. Recruiting at 1 site in United Kingdom. Open to participants aged Up to 37 Weeks. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by Newcastle University · Observational
The goal of this observational study is to develop methods that could provide continual monitoring of comfort levels for preterm neonates in hospitals.
As preterm neonates have not developed ways to communicate how they are feeling like children or adults do, clinicians must rely on their own understanding and professional judgements to decide how comfortable they are. It is known that preterm neonates can display emotion through ways such as facial expressions, body movements and changes in their physiology such as heart rate. The investigators will record both behavioural (audiovisual) and physiologic (heart rate, blood oxygen saturation) signals during routine clinical procedures ranging from comforting, through discomforting to painful that are necessary as part of high-quality medical care.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's planned enrollment of 100 is below the median of 150 across 113 observational studies indexed under Acute Pain.
Browse Acute Pain studies →Newcastle University is the lead sponsor of 59 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Preterm neonates hospitalised in the Royal Victoria Infirmary Neonatal Intensive Care Unit
Exclusion Criteria:
Preterm neonates born \<36 completed weeks of gestation with postmenstrual age \<36 weeks
Pain Score Before Procedure
Score provided by nurses from Neonatal Pain, Agitation \& Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.
Time frame: 1 minute recording before procedure
Audiovisual signal Before Procedure
Bedside recording using camera and microphone.
Time frame: 1 minute starting before procedure
Physiologic Signal Before Procedure: Heart Rate
Heart rate captured by bedside ECG monitor
Time frame: 1 minute starting before procedure
Physiologic Signal Before Procedure: Blood Oxygen Saturation
Blood oxygen saturation captured by bedside oximetry monitor
Time frame: 1 minute starting before procedure
Pain Score During Procedure
Score provided by nurses from Neonatal Pain, Agitation \& Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.
Time frame: 1 minute recording during procedure
Audiovisual Signal During Procedure
Bedside recording using camera and microphone
Time frame: 1 minute during procedure
Physiologic Signal During Procedure: Heart Rate
Heart rate captured by bedside ECG monitor
Time frame: 1 minute during procedure
Physiologic Signal During Procedure: Blood Oxygen Saturation
Blood oxygen saturation captured by bedside oximetry monitor
Time frame: 1 minute during procedure
Pain Score After Procedure
Score provided by nurses from Neonatal Pain, Agitation \& Sedation Scale. Pain/Agitation scores range from 0-13, higher scores indicate higher pain/agitation levels.
Time frame: 1 minute recording immediately after procedure
Audiovisual Signal After Procedure
Bedside recording using camera and microphone
Time frame: 1 minute immediately after procedure
Physiologic Signal After Procedure: Heart Rate
Heart rate captured by bedside ECG monitor
Time frame: 1 minute immediately after procedure
Physiologic Signal After Procedure: Blood Oxygen Saturation
Blood oxygen saturation captured by bedside oximetry monitor
Time frame: 1 minute immediately after procedure
Plan to share: No
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Newcastle University