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CompletedNCT06520735Updated Jun 19, 2025

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

An interventional study of Transcutaneous electrical nerve stimulation and Capsicum plaster in Emesis Pregnancy, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-19.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Emesis Pregnancy

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03

In context

Vomiting

1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.

This study's enrollment of 50 is below the median of 107 across 935 interventional studies indexed under Vomiting.

Browse Vomiting studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • 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

  • Experimental
    Capsicum plaster group

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

    Other: Capsicum plaster

Interventions

  • DeviceTranscutaneous 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.

  • OtherCapsicum 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: within Five days

  2. 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.

    Time frame: within five days

07

Study locations

1 site
  • Peter Bahgat Milad
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06520735
Lead sponsor
Cairo University
Responsible party
Peter Bahgat Milad (Principal investigator, Cairo University) — Principal investigator
First posted
Jul 25, 2024
Start date
Jul 5, 2024
Primary completion
Mar 10, 2025
Completion
Mar 30, 2025
Last update
Jun 19, 2025

Study contacts

Hala Emara, professor
study chair · Cairo University
Mohamed Awad, professor
study director · Cairo University
Amir Arabi, professor
study director · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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