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

NCT07613814 | Completed

• 1 other identifier: EVM-HG-USU-2026
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperemesis Gravidarum

Keywords

Pregnant Women; Vibratory Emesis Massage; Nonpharmacological Therapy; P6 Acupressure; Maternal Nursing

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  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.

  Measured once at baseline during the initial participant selection and screening phase.

Study Arms (2)

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.

Device: Vibratory Emesis Massage

Standard Nursing Care Group

NO INTERVENTION

Participants received standard nursing care for hyperemesis gravidarum without Vibratory Emesis Massage intervention.

Interventions

Vibratory Emesis Massage DEVICE

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.

Also known as: MVE Wristband Therapy

Vibratory Emesis Massage Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: This study evaluates a nursing intervention designed specifically to manage hyperemesis gravidarum, a medical condition that occurs exclusively during pregnancy. Therefore, eligibility is restricted to female participants.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Sumatera Utara: lead

Study Sites (1)

Prof. Dr. Chairuddin Panusunan Lubis Hospital, University of North Sumatra

Medan, North Sumatra, 20155, Indonesia

Location

Related Links

• 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.

MeSH Terms

Conditions

Hyperemesis Gravidarum

Condition Hierarchy (Ancestors)

Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Siti Saidah Nasution, S.Kp., M.Kep., Sp.Mat

  Universitas Sumatera Utara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start: April 10, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)