Laser Acupuncture for Pain Prevention in Neonates

NCT00528125 | Completed

• 1 other identifier: SG-07-H-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

pain prevention; neonatal pain; laser acupuncture; complementary and alternative medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cry Time

  right after after heel prick up to 5 minutes

Study Arms (2)

A

ACTIVE COMPARATOR

Active laser acupuncture

Procedure: active laser acupuncture

B

PLACEBO COMPARATOR

placebo laser acupuncture

Procedure: placebo laser acupuncture

Interventions

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

Also known as: Modulas Handy 2/99, schwamedico, Ehringshausen, Germany

A

placebo laser acupuncture PROCEDURE

placebo laser acupuncture at two acupoints (Hegu, Shen Men). Overall treatment time 30 seconds.

Also known as: placebo laser, Modulas Handy 2/99, schwamedico, Ehringshausen, Germany

B

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Neonates with no obvious underlying disease (genetic (e.g. M. Down), metabolic)and not under pain medication

You may not qualify if:

• Older than 28 days

Sponsors & Collaborators

• University Children Hospital Homburg: lead

Study Sites (1)

University Children Hospital Homburg

Homburg, Saarland, 66421, Germany

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sven Gottschling, MD

  University Children Hospital Homburg, Germany

  PRINCIPAL INVESTIGATOR

• Ludwig Gortner, MD, PhD

  University Children Hospital Homburg, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 12, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: March 29, 2018

Record last verified: 2008-03

Locations

DE (1)