ANSiStim Study for Active Labor Pain

NCT ID: NCT02427139

Last Updated: 2016-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Labor Pain Obstetric Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ANSiStim

Intervention Type DEVICE

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.

Interventions

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ANSiStim

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pregnant Women on an Active Labor

Exclusion Criteria

* Cardiac Pacemaker or any other implants
* Psoriasis
* Diminish mental capacity
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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DyAnsys, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gayathri D Kamath, M.D.

Role: PRINCIPAL_INVESTIGATOR

Fortis Hospital - Bangalore

Locations

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Fortis Hospital

Bangalore, Karnataka, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Murugesh K

Role: CONTACT

04428133748

Jithesh RP, M.B.A.

Role: CONTACT

7708931316

Facility Contacts

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Gayathri D Kamath, M.D.

Role: primary

91-80-6621 4444

Jithesh R P, M.B.A.

Role: backup

917708931316

Other Identifiers

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ANSS-ALP 01

Identifier Type: -

Identifier Source: org_study_id

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