Laser Acupuncture for Pain Prevention in Neonates

Study Overview
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Brief Summary
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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.

Official Title
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Laser Acupuncture for Pain Prevention in Neonates Undergoing Heel Prick. A Prospective, Randomized, Double-blinded Clinical Trial

Conditions
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Pain

Intervention / Treatment
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* Procedure: active laser acupuncture
* Procedure: placebo laser acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonates with no obvious underlying disease (genetic (e.g. M. Down), metabolic)and not under pain medication Exclusion Criteria: Older than 28 days

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Active laser acupuncture | Procedure: active laser acupuncture<br>* 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<br>* Other names: Modulas Handy 2/99, schwamedico, Ehringshausen, Germany;|
| Placebo Comparator: B<br>placebo laser acupuncture | Procedure: placebo laser acupuncture<br>* placebo laser acupuncture at two acupoints (Hegu, Shen Men). Overall treatment time 30 seconds.<br>* Other names: placebo laser, Modulas Handy 2/99, schwamedico, Ehringshausen, Germany;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain prevention, neonatal pain, laser acupuncture, complementary and alternative medicine