Emesis PregnancyNCT06520735
Effect of Transcutaneous Electrical Nerve Stimulation Versus Capsicum Plaster on Emesis Gravidarum
A study testing Transcutaneous electrical nerve stimulation and Capsicum plaster in people with Emesis Pregnancy, run by Cairo University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emesis Pregnancy
- What is being tested?
- Transcutaneous electrical nerve stimulation and Capsicum plaster
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jul 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Emesis Pregnancy
- Being tested
- Transcutaneous electrical nerve stimulation, Capsicum plaster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulationDevice
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 plasterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Capsicum plaster |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: within five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start5 Jul 2024
- Primary completion10 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emesis PregnancyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Bahgat Milad, Cairo University
- Investigators
- Hala Emara, professor, Study chair, Cairo UniversityMohamed Awad, professor, Study director, Cairo UniversityAmir Arabi, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520735
- Sponsor's protocol ID
- P.T.REC/012/003610
- Status last verified
- Aug 2024
- First submitted
- 20 Jul 2024
- Last updated
- 19 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Nerve Stimulation Versus Capsicum Plaster on Emesis Gravidarum
- ClinicalTrials.gov ID
- NCT06520735
- Acronym / sponsor ID
- P.T.REC/012/003610
- Conditions
- Emesis Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical nerve stimulation group | Experimental | Device: Transcutaneous electrical nerve stimulationThe pregnant women with emesis gravidarum will be treated by transcutaneous electrical nerve stimulation on the P6 acupuncture point. |
| Capsicum plaster group | Experimental | Other: Capsicum plasterThe pregnant women with emesis gravidarum will be treated with capsicum plaster on the P6 acupuncture point. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Previous carpal tunnel syndrome.
- Skin abnormalities
- Acute viral disease
- Hyperemesis gravidarum.
- Previous history of nausea or vomiting before pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical nerve stimulationThe 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. | Device | Transcutaneous electrical nerve stimulation group |
| Capsicum plasterThe pregnant women with emesis gravidarum will be treated with capsicum plaster on p6 acupuncture point for 12 hours per day for 5 consecutive days. | Other | Capsicum plaster group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala Emara, professor study chair
Cairo University
Mohamed Awad, professor study director
Cairo University
Amir Arabi, professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation and Capsicum plaster in people with Emesis Pregnancy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhodes index for nausea and vomiting and retching (time frame: within Five days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.