ANSiStim Study for Active Labor Pain
ANSS-ALP
Study of ANSiStim for Pain Relief During Active Labor Phase Through Continues Checking of VAS SCORE
1 other identifier
interventional
50
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 21, 2015
CompletedFirst Posted
Study publicly available on registry
April 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedMay 24, 2016
May 1, 2016
1.5 years
April 21, 2015
May 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Evidence of Reduced Pain (Pain Scale of 5) in Active Labor Phase after ANSiStim Placement
48 Hours
Study Arms (1)
ANSiStim
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Pregnant Women on an Active Labor
You may not qualify if:
- Cardiac Pacemaker or any other implants
- Psoriasis
- Diminish mental capacity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DyAnsys, Inc.lead
Study Sites (1)
Fortis Hospital
Bangalore, Karnataka, 560 076, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gayathri D Kamath, M.D.
Fortis Hospital - Bangalore
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2015
First Posted
April 27, 2015
Study Start
March 1, 2015
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
May 24, 2016
Record last verified: 2016-05