ANSiStim Study for Active Labor Pain (ANSS-ALP)
|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
|Condition or disease||Intervention/treatment||Phase|
|Labor Pain Obstetric Pain||Device: ANSiStim||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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|
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.
- Evidence of Reduced Pain (Pain Scale of 5) in Active Labor Phase after ANSiStim Placement [ Time Frame: 48 Hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427139
|Contact: Murugesh Kemail@example.com|
|Contact: Jithesh RP, M.B.A.||firstname.lastname@example.org|
|Principal Investigator:||Gayathri D Kamath, M.D.||Fortis Hospital - Bangalore|