Hyperemesis GravidarumVEMNCT07613814
Development of a Management Model for Hyperemesis in Pregnant Women Through the "Vibratory Emesis Massage"
A study testing Vibratory Emesis Massage in people with Hyperemesis Gravidarum, run by Universitas Sumatera Utara at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hyperemesis Gravidarum
- What is being tested?
- Vibratory Emesis Massage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Apr 2026to 15 Apr 2026
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Prof. Dr. Chairuddin Panusunan Lubis Hospital, University of North Sumatra
Medan, North Sumatra, 20155
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperemesis Gravidarum
- Being tested
- Vibratory Emesis Massage
- Keywords
- Pregnant Women, Vibratory Emesis Massage, Nonpharmacological Therapy, P6 Acupressure, Maternal Nursing
- Medical subject headings
- Hyperemesis Gravidarum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibratory Emesis MassageDevice
Also called MVE Wristband Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Vibratory Emesis Massage Group | Experimental | 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. Receives: Device: Vibratory Emesis Massage |
| Standard Nursing Care Group | No intervention | Participants received standard nursing care for hyperemesis gravidarum without Vibratory Emesis Massage intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Severity of Nausea and Vomiting Symptoms.
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)
Measured: 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 outcomes (2)
Device Safety and Treatment Discomfort.
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.
Measured: 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.
Maternal Demographic and Baseline Clinical Characteristics.
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: Measured once at baseline during the initial participant selection and screening phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start10 Apr 2026
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperemesis GravidarumStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned into intervention and control groups using a quasi-experimental pretest-posttest non-equivalent group design. The intervention group received Vibratory Emesis Massage therapy, while the control group received standard nursing care.
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sumatera Utara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siti Saidah Nasution, Universitas Sumatera Utara
- Investigators
- Siti Saidah Nasution, S.Kp., M.Kep., Sp.Mat, Principal investigator, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613814
- Sponsor's protocol ID
- EVM-HG-USU-2026
- Acronym
- VEM
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07613814
- Acronym / sponsor ID
- VEM / EVM-HG-USU-2026
- Conditions
- Hyperemesis Gravidarum
- Keywords
- Pregnant Women, Vibratory Emesis Massage, Nonpharmacological Therapy, P6 Acupressure, Maternal Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Universitas Sumatera UtaraUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 29 May 2026 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned into intervention and control groups using a quasi-experimental pretest-posttest non-equivalent group design. The intervention group received Vibratory Emesis Massage therapy, while the control group received standard nursing care.
| Arm | Type | Receives |
|---|---|---|
| Vibratory Emesis Massage Group | Experimental | Device: Vibratory Emesis MassageParticipants 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. |
| Standard Nursing Care Group | No intervention | –Participants received standard nursing care for hyperemesis gravidarum without Vibratory Emesis Massage intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Vibratory Emesis MassageAlso: MVE Wristband TherapyParticipants 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. | Device | Vibratory Emesis Massage Group |
Primary outcome
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)
2 secondary outcomes
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.
Maternal Demographic and Baseline Clinical Characteristics.
Time frame: Measured once at baseline during the initial participant selection and screening phase.
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 2 Jun 2026.
- Background literature evaluating the clinical efficacy and physiological mechanisms of non-pharmacological acupressure stimulation at the Pericardium 6 (P6) acupoint for mitigating pregnancy-related nausea and vomiting.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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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.
Siti Saidah Nasution, S.Kp., M.Kep., Sp.Mat principal investigator
Universitas Sumatera Utara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibratory Emesis Massage in people with Hyperemesis Gravidarum, run by Universitas Sumatera Utara at 1 site in Indonesia.
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 5 inclusion and 4 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 2 Jun 2026. 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 Indonesia. 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?
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).). 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 2 Jun 2026.