ANSiStim Study for Active Labor Pain

Not Applicable

• Conditions: Labor Pain; Obstetric Pain
• Interventions: Device: ANSiStim

• Registration Number: NCT02427139
• Lead Sponsor: 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 .

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-04-24
• Study First Posted: 2015-04-27
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-21
• Last Update Posted: 2016-05-24
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Pregnant Women on an Active Labor

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ANSiStim	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.

Primary Outcome Measures

Name	Time	Method
Evidence of Reduced Pain (Pain Scale of 5) in Active Labor Phase after ANSiStim Placement	48 Hours

Trial Locations

Locations (1)

Fortis Hospital; 🇮🇳 Bangalore, Karnataka, India