Development of a Management Model for Hyperemesis in Pregnant Women Through the "Vibratory Emesis Massage" (VEM)

May 28, 2026 updated by: Siti Saidah Nasution, Universitas Sumatera Utara

Development of a Management Model for Hyperemesis in Pregnant Women Through the "Vibratory Emesis Massage" Nursing Intervention at Prof. Chairuddin Panusunan Lubis Hospital, University of North Sumatra

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hyperemesis gravidarum is a condition characterized by severe nausea and vomiting during pregnancy that may affect nutritional status, fluid balance, and quality of life. Non-pharmacological therapies such as acupressure and massage stimulation have increasingly been used as complementary approaches to reduce symptoms during pregnancy.

This study developed a nursing intervention model called Vibratory Emesis Massage (VEM), which combines vibratory stimulation and acupressure at the Pericardium 6 (P6) point using a wearable wristband device. The intervention was designed to reduce nausea and vomiting symptoms in pregnant women through peripheral nerve stimulation and relaxation mechanisms.

The study used a quasi-experimental pretest-posttest non-equivalent control group design involving 240 pregnant women diagnosed with hyperemesis gravidarum at Prof. Dr. Chairuddin Panusunan Lubis Hospital, University of North Sumatra. Participants were divided into intervention and control groups. The intervention group received Vibratory Emesis Massage therapy for 15-20 minutes per session.

The severity of nausea and vomiting was measured using the Pregnancy Unique Quantification of Emesis (PUQE-24) questionnaire before and after the intervention. Data were analyzed using the Wilcoxon Signed-Rank Test and Mann-Whitney U Test to determine the effectiveness of the intervention.

The study aimed to provide evidence for the effectiveness of Vibratory Emesis Massage as a practical, safe, non-invasive, and nurse-led intervention for managing nausea and vomiting in pregnant women.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • North Sumatra
      • Medan, North Sumatra, Indonesia, 20155
        • Prof. Dr. Chairuddin Panusunan Lubis Hospital, University of North Sumatra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vibratory Emesis Massage Group
Participants received Vibratory Emesis Massage therapy using a vibratory wristband device applied at the Pericardium 6 (P6) acupoint for approximately 15-20 minutes per session, administered 1-2 times daily in addition to standard nursing care.
Device: Vibratory Emesis Massage
Participants received Vibratory Emesis Massage therapy using a vibratory wristband device applied at the Pericardium 6 (P6) point for approximately 15-20 minutes per session to reduce nausea and vomiting during pregnancy.
Other Names:
  • MVE Wristband Therapy
No Intervention: Standard Nursing Care Group
Participants received standard nursing care for hyperemesis gravidarum without Vibratory Emesis Massage intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Severity of Nausea and Vomiting Symptoms.
Time Frame: 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).

The frequency and clinical severity of hyperemesis gravidarum are assessed using the researcher-modified Pregnancy Unique Quantification of Emesis (PUQE-24) questionnaire. For clinical macro-level analysis, the continuous index scores are converted into an ordinal scale:

Score 1 : Mild category (PUQE index score <6). Score 2 : Moderate category (PUQE index score 7-12) Score 3 : Severe category (PUQE index score >13)
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Demographic and Baseline Clinical Characteristics.
Time Frame: Measured once at baseline during the initial participant selection and screening phase.
Evaluation of baseline participant characteristics using the researcher's modified structured questionnaire to establish descriptive control data. Recorded categorical variables include: Maternal age (categorized as 18-25, 26-35, or 36-45 years old). Highest educational attainment (Elementary, Middle School, High School, or College). Employment status/Occupation (Civil Servant, Self-Employed, or Housewife). Marriage age, past medical history, gravidity, parity, and the specific stage of pregnancy (First, Second, or Third trimester)
Measured once at baseline during the initial participant selection and screening phase.
Device Safety and Treatment Discomfort.
Time Frame: Assessed continuously from the first intervention session (Day 1) until completion of the intervention period (Day 3), including monitoring during hospital care and home follow-up visits.
Continuous researcher observation and participant monitoring for any perceived physical complaints or adverse effects (such as localized wrist pain or skin discomfort) associated with the application of the Vibratory Emesis Massage (VEM) wristband over the Pericardium 6 (P6) acupoint.
Assessed continuously from the first intervention session (Day 1) until completion of the intervention period (Day 3), including monitoring during hospital care and home follow-up visits.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sumatera Utara

Investigators

  • Principal Investigator: Siti Saidah Nasution, S.Kp., M.Kep., Sp.Mat, Universitas Sumatera Utara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2026

Primary Completion (Actual)

April 15, 2026

Study Completion (Actual)

April 15, 2026

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVM-HG-USU-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data will not be publicly shared to protect the confidentiality and privacy of the pregnant women who participated in this study, in accordance with the ethical approval and informed consent signed by the participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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