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ANSiStim Study for Active Labor Pain (ANSS-ALP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02427139
Recruitment Status : Unknown
Verified May 2016 by DyAnsys, Inc..
Recruitment status was:  Recruiting
First Posted : April 27, 2015
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
DyAnsys, Inc.

Brief Summary:
The specific aim of the study is to do comparison between ANSiStim and Placebo for pain relief in labor. During the treatment, pain relief will be assesed with ANSiStim in active labor through continues checking of VAS SCORE. ANSiStim has been tried in post operative patients with good pain relief .

Condition or disease Intervention/treatment Phase
Labor Pain Obstetric Pain Device: ANSiStim Not Applicable

Detailed Description:
Pain during labor is caused by contractions of the muscles of the uterus and by pressure on the cervix. This pain can be felt as strong cramping in the abdomen, groin, and back, as well as an achy feeling. Some women experience pain in their sides or thighs as well. Most women have an epidural or spinal during labour or after the birth.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Study of ANSiStim for Pain Relief During Active Labor Phase Through Continues Checking of VAS SCORE
Study Start Date : March 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: ANSiStim

The ANSiStim device is designed to administer auricular point stimulation treatment over several days. The advantage of using the ear for this treatment is that it provides numerous points for stimulation within a small area. Stimulation is performed by electrical pulses emitted through strategically positioned needles.

Three zinc air batteries with 1.4 V provide the required stimulation energy for 96 hours. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The treatment period varies based on the severity of the pain. To minimize the risk of adaption or tolerance to the electrical stimulation, it is applied for 3 hours, followed by a pause of 3 hours.

Device: ANSiStim
ANSiStim allows continuous point stimulation over a period of several days while offering the patient a high degree of comfort and mobility at the same time. Use of the ANSiSTIM therapy provides overwhelming advantage over drug therapy minimizing possible side-effects caused by pain medications (i.e. opioid) such as, for example, impaired reactions. In most cases, the patient continues to lead its life as normal, without side effects or any loss of quality of life.




Primary Outcome Measures :
  1. Evidence of Reduced Pain (Pain Scale of 5) in Active Labor Phase after ANSiStim Placement [ Time Frame: 48 Hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant Women on an Active Labor

Exclusion Criteria:

  • Cardiac Pacemaker or any other implants
  • Psoriasis
  • Diminish mental capacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427139


Contacts
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Contact: Murugesh K 04428133748 k.murugesh@dyansys.com
Contact: Jithesh RP, M.B.A. 7708931316 r.p.jithesh@dyansys.com

Locations
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India
Fortis Hospital Recruiting
Bangalore, Karnataka, India, 560 076
Contact: Gayathri D Kamath, M.D.    91-80-6621 4444    enquiries@fortishealthcare.com   
Contact: Jithesh R P, M.B.A.    917708931316    r.p.jithesh@dyansys.com   
Sponsors and Collaborators
DyAnsys, Inc.
Investigators
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Principal Investigator: Gayathri D Kamath, M.D. Fortis Hospital - Bangalore
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Responsible Party: DyAnsys, Inc.
ClinicalTrials.gov Identifier: NCT02427139    
Other Study ID Numbers: ANSS-ALP 01
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms