- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02427139
ANSiStim Study for Active Labor Pain (ANSS-ALP)
Study of ANSiStim for Pain Relief During Active Labor Phase Through Continues Checking of VAS SCORE
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Murugesh K
- Phone Number: 04428133748
- Email: k.murugesh@dyansys.com
Study Contact Backup
- Name: Jithesh RP, M.B.A.
- Phone Number: 7708931316
- Email: r.p.jithesh@dyansys.com
Study Locations
-
-
Karnataka
-
Bangalore, Karnataka, India, 560 076
- Recruiting
- Fortis Hospital
-
Contact:
- Gayathri D Kamath, M.D.
- Phone Number: 91-80-6621 4444
- Email: enquiries@fortishealthcare.com
-
Contact:
- Jithesh R P, M.B.A.
- Phone Number: 917708931316
- Email: r.p.jithesh@dyansys.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnant Women on an Active Labor
Exclusion Criteria:
- Cardiac Pacemaker or any other implants
- Psoriasis
- Diminish mental capacity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evidence of Reduced Pain (Pain Scale of 5) in Active Labor Phase after ANSiStim Placement
Time Frame: 48 Hours
|
48 Hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gayathri D Kamath, M.D., Fortis Hospital - Bangalore
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANSS-ALP 01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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