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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Standard Nursing Care Group | No Intervention | Participants received standard nursing care for hyperemesis gravidarum without Vibratory Emesis Massage intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Siti Saidah Nasution, S.Kp., M.Kep., Sp.Mat | Universitas Sumatera Utara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Dr. Chairuddin Panusunan Lubis Hospital, University of North Sumatra | Medan | North Sumatra | 20155 | Indonesia |
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| Label | URL |
|---|---|
| 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. | View source |
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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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| ID | Term |
|---|---|
| D006939 | Hyperemesis Gravidarum |
| ID | Term |
|---|---|
| D048968 | Morning Sickness |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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| 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 once at baseline during the initial participant selection and screening phase. |
| D014839 | Vomiting |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |