Laser Acupuncture for Pain Prevention in Neonates

NCT ID: NCT00528125

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-01-31

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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Active laser acupuncture

Group Type ACTIVE_COMPARATOR

active laser acupuncture

Intervention Type 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

B

placebo laser acupuncture

Group Type PLACEBO_COMPARATOR

placebo laser acupuncture

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

placebo laser acupuncture

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

Intervention Type PROCEDURE

Other Intervention Names

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Modulas Handy 2/99, schwamedico, Ehringshausen, Germany placebo laser, Modulas Handy 2/99, schwamedico, Ehringshausen, Germany

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
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Children Hospital Homburg

OTHER

Sponsor Role lead

Principal Investigators

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Sven Gottschling, MD

Role: PRINCIPAL_INVESTIGATOR

University Children Hospital Homburg, Germany

Ludwig Gortner, MD, PhD

Role: STUDY_DIRECTOR

University Children Hospital Homburg, Germany

Locations

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University Children Hospital Homburg

Homburg, Saarland, Germany

Site Status

Countries

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Germany

Other Identifiers

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SG-07-H-02

Identifier Type: -

Identifier Source: org_study_id

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