Laser Acupuncture for Pain Prevention in Neonates

March 27, 2018 updated by: University Children Hospital Homburg

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • University Children Hospital Homburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Pain score Premature Infant Pain Profile (PIPP), according to video analysis
Time Frame: 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.
5 minutes from the heel prick

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cry Time
Time Frame: right after after heel prick up to 5 minutes
in seconds (according to the Audio track of the video analysis)
right after after heel prick up to 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children Hospital Homburg

Investigators

  • Principal Investigator: Sven Gottschling, MD, University Children Hospital Homburg, Germany
  • Study Director: Ludwig Gortner, MD, PhD, University Children Hospital Homburg, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 11, 2007

First Submitted That Met QC Criteria

September 11, 2007

First Posted (Estimate)

September 12, 2007

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SG-07-H-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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