Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 .
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANSiStim | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ANSiStim | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of Reduced Pain (Pain Scale of 5) in Active Labor Phase after ANSiStim Placement | 48 Hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Murugesh K | Contact | 04428133748 | k.murugesh@dyansys.com | |
| Jithesh RP, M.B.A. | Contact | 7708931316 | r.p.jithesh@dyansys.com |
| Name | Affiliation | Role |
|---|---|---|
| Gayathri D Kamath, M.D. | Fortis Hospital - Bangalore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortis Hospital | Recruiting | Bangalore | Karnataka | 560 076 | India |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 4, 2018 | |
| Reset | Mar 15, 2019 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 4, 2018 | Mar 15, 2019 |
| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|