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

NCT06520735 | Completed

• 1 other identifier: P.T.REC/012/003610
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Emesis Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Transcutaneous electrical nerve stimulation group

EXPERIMENTAL

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

Device: Transcutaneous electrical nerve stimulation

Capsicum plaster group

EXPERIMENTAL

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

Other: Capsicum plaster

Interventions

Transcutaneous electrical nerve stimulation 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.

Transcutaneous electrical nerve stimulation group

Capsicum plaster 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.

Capsicum plaster group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Peter Bahgat Milad

Cairo, Egypt

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Hala Emara, professor

  Cairo University

  STUDY CHAIR

• Mohamed Awad, professor

  Cairo University

  STUDY DIRECTOR

• Amir Arabi, professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 20, 2024
• First Posted: July 25, 2024
• Study Start: July 5, 2024
• Primary Completion: March 10, 2025
• Study Completion: March 30, 2025
• Last Updated: June 19, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)