Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

28 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

240

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.
Andere namen:
  • MVE Wristband Therapy
Geen tussenkomst: Standard Nursing Care Group
Participants received standard nursing care for hyperemesis gravidarum without Vibratory Emesis Massage intervention.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in the Severity of Nausea and Vomiting Symptoms.
Tijdsspanne: 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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maternal Demographic and Baseline Clinical Characteristics.
Tijdsspanne: 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.
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universitas Sumatera Utara

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 april 2026

Primaire voltooiing (Werkelijk)

15 april 2026

Studie voltooiing (Werkelijk)

15 april 2026

Studieregistratiedata

Eerst ingediend

21 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

28 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • EVM-HG-USU-2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren