PainNCT00528125
Laser Acupuncture for Pain Prevention in Neonates
A study testing active laser acupuncture in people with Pain, run by University Children Hospital Homburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- active laser acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Neonates with no obvious underlying disease (genetic (e.g. M. Down), metabolic)and not under pain medication
Who cannot join
- Older than 28 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pain
- Being tested
- active laser acupuncture, placebo laser acupuncture
- Keywords
- pain prevention, neonatal pain, laser acupuncture, complementary and alternative medicine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active laser acupunctureProcedure or surgery
Also called Modulas Handy 2/99, schwamedico, Ehringshausen, Germany
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
placebo laser acupunctureProcedure or surgery
Also called placebo laser, Modulas Handy 2/99, schwamedico, Ehringshausen, Germany
placebo laser acupuncture at two acupoints (Hegu, Shen Men). Overall treatment time 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Active laser acupuncture Receives: Procedure: active laser acupuncture |
| B | Placebo comparator | placebo laser acupuncture Receives: Procedure: placebo laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes from the heel prick
Secondary outcomes (1)
Cry Time
in seconds (according to the Audio track of the video analysis)
Measured: right after after heel prick up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children Hospital Homburg
- Sponsor type
- University, hospital or other
- Investigators
- Sven Gottschling, MD, Principal investigator, University Children Hospital Homburg, GermanyLudwig Gortner, MD, PhD, Study director, University Children Hospital Homburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528125
- Sponsor's protocol ID
- SG-07-H-02
- Status last verified
- Mar 2008
- First submitted
- 11 Sep 2007
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Acupuncture for Pain Prevention in Neonates Undergoing Heel Prick. A Prospective, Randomized, Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT00528125
- Acronym / sponsor ID
- SG-07-H-02
- Conditions
- Pain
- Keywords
- pain prevention, neonatal pain, laser acupuncture, complementary and alternative medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Children Hospital HomburgUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 12 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: active laser acupunctureActive laser acupuncture |
| B | Placebo comparator | Procedure: placebo laser acupunctureplacebo laser acupuncture |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates with no obvious underlying disease (genetic (e.g. M. Down), metabolic)and not under pain medication
Key exclusion criteria (1 listed)
- Older than 28 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active laser acupunctureAlso: Modulas Handy 2/99, schwamedico, Ehringshausen, Germanylow 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 | Procedure or surgery | A |
| placebo laser acupunctureAlso: placebo laser, Modulas Handy 2/99, schwamedico, Ehringshausen, Germanyplacebo laser acupuncture at two acupoints (Hegu, Shen Men). Overall treatment time 30 seconds. | Procedure or surgery | B |
Primary outcome
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.
1 secondary outcome
Cry Time
Time frame: right after after heel prick up to 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Gottschling, MD principal investigator
University Children Hospital Homburg, Germany
Ludwig Gortner, MD, PhD study director
University Children Hospital Homburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active laser acupuncture in people with Pain, run by University Children Hospital Homburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pain score Premature Infant Pain Profile (PIPP), according to video analysis (time frame: 5 minutes from the heel prick). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.