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

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

Study Overview

• Status: Completed
• Conditions: Emesis Pregnancy
• Intervention / Treatment: Device: Transcutaneous electrical nerve stimulation; Other: Capsicum plaster

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Peter Bahgat Milad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous electrical nerve stimulation group; The pregnant women with emesis gravidarum will be treated by transcutaneous electrical nerve stimulation on the P6 acupuncture point.	Device: 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.
Experimental: Capsicum plaster group; The pregnant women with emesis gravidarum will be treated with capsicum plaster on the P6 acupuncture point.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rhodes index for nausea and vomiting and retching	It will be used to assess the severity of nausea (N), vomiting (V) and retching (R) for both groups before and after treatment. It is an instrument consisting of eight 5-point self report items measuring the individual's perception of duration of nausea, frequency of nausea, distress from nausea, frequency of vomiting, amount of vomiting, distress from vomiting, frequency of retching, and distress from retching. Its score ranges from 0 to 32. A score of 0 indicated no nausea, vomiting, or retching (NVR), 1-8 indicated mild NVR, 9-16 indicated moderate NVR, 17-24 indicated severe NVR, and 24-32 indicated the worst levels of NVR.	within Five days
Modified pregnancy unique quantification of emesis and nausea (MPUQE)	Nausea and vomiting of pregnancy (NVP) were measured and classified into three groups of different severity by using the 24-h Modified Pregnancy Unique Quantification of Emesis Scale (PUQE). MPUQE consists of three items that are used to assess the severity of NVP; the number of hours of nausea, the number of episodes of retching, and the number of episodes of vomiting within the last 24 hours. Each item has five options which are scored from 1 to 5 points. The MPUQE score is calculated by adding the values from each item which adds up to a total score that ranges from 3 to 15 points. The obtained total MPUQE-score was used to classify the severity of NVP into mild ≤6 points; moderate 7-12 points; severe ≥13 points.	within five days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Hala Emara, professor, Cairo university; Study Director: Mohamed Awad, professor, Cairo university; Study Director: Amir Arabi, professor, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2024
• Primary Completion (Actual): March 10, 2025
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: July 20, 2024
• First Submitted That Met QC Criteria: July 20, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting
• Other Study ID Numbers: P.T.REC/012/003610

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No