Development of a Management Model for Hyperemesis in Pregnant Women Through the "Vibratory Emesis… (NCT07613814) | Clinical Trial Compass
CompletedNot Applicable
Development of a Management Model for Hyperemesis in Pregnant Women Through the "Vibratory Emesis Massage"
Indonesia240 participantsStarted 2026-04-10
Plain-language summary
This study aimed to develop and evaluate a hyperemesis management model through the Vibratory Emesis Massage (VEM) nursing intervention in pregnant women experiencing nausea and vomiting. This quasi-experimental study used a pretest-posttest non-equivalent group design involving intervention and control groups. The intervention was administered at the Pericardium 6 (P6) point using a vibratory massage wristband for 15-20 minutes. The study evaluated the effectiveness of the intervention in reducing the severity of nausea and vomiting among pregnant women.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pregnant women diagnosed with emesis gravidarum or hyperemesis gravidarum.
* Gestational age within the first, second, or third trimester (with a focus on those experiencing active nausea and vomiting symptoms).
* Aged between 18 and 45 years.
* Admitted to or receiving care at Prof. Dr. Chairuddin Panusunan Lubis Hospital, University of North Sumatra.
* Willing to participate in the study and capable of providing written informed consent.
Exclusion Criteria:
* Pregnant women with severe medical complications unrelated to hyperemesis (e.g., severe cardiovascular disease, active skin infections, or open wounds at the Pericardium 6 / P6 acupoint area on the wrist).
* Patients receiving concurrent alternative non-pharmacological therapies for nausea and vomiting that could confound the study results.
* Patients who are unable to complete the assigned 15-to-20-minute Vibratory Emesis Massage (MVE) sessions due to acute physical or cognitive distress.
* Participants who choose to withdraw from the hospital treatment or study protocol before the post-test evaluation is completed.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Severity of Nausea and Vomiting Symptoms.
Timeframe: Assessed at baseline (pre-test, prior to receiving the device stimulation) and reassessed at the post-test evaluation phase (following the completion of the assigned therapy sessions).