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Pain prevention and/or therapy in neonates is still a challenge. It is widely accepted that early pain experience can have a tremendous impact on the pain memory. We want to investigate if a simple, fast method, that is nearly devoid of side effects can lead to a significant alleviation of pain sensation in neonates. Acupuncture has been shown to be effective in various painful conditions. Trials on acupuncture in children are rare. Trials on acupuncture in neonates are lacking so far. Our hypothesis is that neonates in the active laser group experience less pain than those in the placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Active laser acupuncture |
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| B | Placebo Comparator | placebo laser acupuncture |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active laser acupuncture | Procedure | low level laser acupuncture, 830 nm, 30 mW, 0,3 J per acupoint, 2 points per neonate (Hegu and Shen Men). Overall 30 seconds of treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| The Pain score Premature Infant Pain Profile (PIPP), according to video analysis | The Premature Infant Pain Profile (PIPP Score) is a reliable instrument to measure acute pain in neonates and it includes objective vital parameters and is not only a third-party observation. A total of seven indicators are measured: Three behavioural indicators (facial actions: eye squeeze, brow bulge and nasolabial furrow), two physiological indicators (heart rate and oxygen saturation), and two contextual indicators (gestational age and behavioral state). A scoring of 0, 1, 2 or 3 points is used for each of the seven indicators. All indicators are summed up to a total score. Depending on the gestational age, the possible total score ranges from 18 to 21. | 5 minutes from the heel prick |
| Measure | Description | Time Frame |
|---|---|---|
| Cry Time | in seconds (according to the Audio track of the video analysis) | right after after heel prick up to 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sven Gottschling, MD | University Children Hospital Homburg, Germany | Principal Investigator |
| Ludwig Gortner, MD, PhD | University Children Hospital Homburg, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children Hospital Homburg | Homburg | Saarland | 66421 | Germany |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| placebo laser acupuncture | Procedure | placebo laser acupuncture at two acupoints (Hegu, Shen Men). Overall treatment time 30 seconds. |
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