Pain
Conditions
Keywords
pain prevention, neonatal pain, laser acupuncture, complementary and alternative medicine
Brief summary
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.
Interventions
PROCEDUREactive laser acupuncture
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
PROCEDUREplacebo laser acupuncture
placebo laser acupuncture at two acupoints (Hegu, Shen Men). Overall treatment time 30 seconds.
Sponsors
University Children Hospital Homburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Pain score Premature Infant Pain Profile (PIPP), according to video analysis | 5 minutes from the heel prick | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cry Time | right after after heel prick up to 5 minutes | in seconds (according to the Audio track of the video analysis) |
Countries
Germany
Outcome results
None listed