Effect of Transcutaneous Electrical Nerve Stimulation Versus Capsicum Plaster on Emesis Gravidarum

NCT ID: NCT06520735

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-05
• Study Completion Date: 2025-03-30

Brief Summary

This study will be conducted to determine the difference between the effect of transcutaneous electrical nerve stimulation and capsicum plaster on emesis gravidarum.

Detailed Description

Almost 50-90% of pregnant women experience nausea vomiting in the first trimester. Nausea vomiting occurs in 60% -80% primigravida and 40% -60% in multigravida.It is revealed that 50% of affected women have a significant reduction of their work efficiency.

Transcutaneous acupoint electrical stimulation (TAES) at the Nei-Guan P6 acupoint may be a useful alternative to antiemetic drugs. It is effective in the treatment of both motion sickness and pregnancy induced nausea and vomiting , as well as emesis associated with chemotherapy.

Capsicum plaster is an alternative to acupuncture. It is applied to the acupuncture points and has been reported to be an effective method for preventing postoperative nausea and vomiting (PONV), postoperative sore throat, and postoperative pain.

Conditions

Emesis Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Transcutaneous electrical nerve stimulation group

The pregnant women with emesis gravidarum will be treated by transcutaneous electrical nerve stimulation on the P6 acupuncture point.

Group Type: EXPERIMENTAL

Transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

The pregnant women with emesis gravidarum will be treated by transcutaneous electrical nerve stimulation (TENS) on p6 acupuncture point for 30 minutes daily for 5 consecutive days.

Capsicum plaster group

The pregnant women with emesis gravidarum will be treated with capsicum plaster on the P6 acupuncture point.

Group Type: EXPERIMENTAL

Capsicum plaster

Intervention Type: OTHER

The pregnant women with emesis gravidarum will be treated with capsicum plaster on p6 acupuncture point for 12 hours per day for 5 consecutive days.

Interventions

Transcutaneous electrical nerve stimulation

The pregnant women with emesis gravidarum will be treated by transcutaneous electrical nerve stimulation (TENS) on p6 acupuncture point for 30 minutes daily for 5 consecutive days.

Intervention Type: DEVICE

Capsicum plaster

The pregnant women with emesis gravidarum will be treated with capsicum plaster on p6 acupuncture point for 12 hours per day for 5 consecutive days.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Pregnant women complaining of emesis gravidarum
• Their ages will be ranged from 20 to 35 years old.
• Their body mass index will not exceed 35 kg/ m2.
• Their gestational age will be less than 20 weeks.
• All women having mild to moderate nausea and/or vomiting
• All women having singleton pregnancy

Exclusion Criteria

Women will be excluded from the study if they have:

• Previous carpal tunnel syndrome.
• Skin abnormalities
• Acute viral disease
• Hyperemesis gravidarum.
• Previous history of nausea or vomiting before pregnancy.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Peter Bahgat Milad

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala Emara, professor

Role: STUDY_CHAIR

Cairo University

Mohamed Awad, professor

Role: STUDY_DIRECTOR

Cairo University

Amir Arabi, professor

Role: STUDY_DIRECTOR

Cairo University

Locations

Peter Bahgat Milad

Cairo, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/003610

Identifier Type: -

Identifier Source: org_study_id