ANSiStim Study for Active Labor Pain (ANSS-ALP)

DyAnsys

Status: Unknown

Conditions: Labor Pain; Obstetric Pain

Treatments: Device: ANSiStim

Study type: Interventional

Funder types: Industry

Identifiers

NCT02427139

ANSS-ALP 01

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant Women on an Active Labor

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

ANSiStim

Experimental group

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.

Treatment:

Device: ANSiStim