Back to resultsANSiStim Study for Active Labor Pain (ANSS-ALP)
Primary Purpose
Labor Pain, Obstetric Pain
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
ANSiStim
Sponsored by
About this trial
This is an interventional supportive care trial for Labor Pain
Eligibility Criteria
Inclusion Criteria:
- Pregnant Women on an Active Labor
Exclusion Criteria:
- Cardiac Pacemaker or any other implants
- Psoriasis
- Diminish mental capacity
Sites / Locations
- Fortis HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ANSiStim
Arm Description
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.
Outcomes
Primary Outcome Measures
Evidence of Reduced Pain (Pain Scale of 5) in Active Labor Phase after ANSiStim Placement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02427139
Brief Title
ANSiStim Study for Active Labor Pain
Acronym
ANSS-ALP
Official Title
Study of ANSiStim for Pain Relief During Active Labor Phase Through Continues Checking of VAS SCORE
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DyAnsys, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 .
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Obstetric Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ANSiStim
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ANSiStim
Intervention Description
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 Measure Information:
Title
Evidence of Reduced Pain (Pain Scale of 5) in Active Labor Phase after ANSiStim Placement
Time Frame
48 Hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant Women on an Active Labor
Exclusion Criteria:
Cardiac Pacemaker or any other implants
Psoriasis
Diminish mental capacity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Murugesh K
Phone
04428133748
Email
k.murugesh@dyansys.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jithesh RP, M.B.A.
Phone
7708931316
Email
r.p.jithesh@dyansys.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gayathri D Kamath, M.D.
Organizational Affiliation
Fortis Hospital - Bangalore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fortis Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 076
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gayathri D Kamath, M.D.
Phone
91-80-6621 4444
Email
enquiries@fortishealthcare.com
First Name & Middle Initial & Last Name & Degree
Jithesh R P, M.B.A.
Phone
917708931316
Email
r.p.jithesh@dyansys.com
12. IPD Sharing Statement
Learn more about this trial
ANSiStim Study for Active Labor Pain
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