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Clinical Trials/NCT06520735
NCT06520735
Completed
Not Applicable

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

Cairo University1 site in 1 country50 target enrollmentJuly 5, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emesis Pregnancy
Sponsor
Cairo University
Enrollment
50
Locations
1
Primary Endpoint
Modified pregnancy unique quantification of emesis and nausea (MPUQE)
Status
Completed
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 5, 2024
End Date
March 30, 2025
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Peter Bahgat Milad

Principal investigator

Cairo University

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/ m
  • 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.

Outcomes

Primary Outcomes

Modified pregnancy unique quantification of emesis and nausea (MPUQE)

Time Frame: within five days

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.

Rhodes index for nausea and vomiting and retching

Time Frame: within Five days

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.

Study Sites (1)

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