Development of a Management Model for Hyperemesis in Pregnant Women Through the "Vibratory Emesis Massage" (VEM)
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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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North Sumatra
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Medan、North Sumatra、インドネシア、20155
- Prof. Dr. Chairuddin Panusunan Lubis Hospital, University of North Sumatra
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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.
他の名前：
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介入なし：Standard Nursing Care Group
Participants received standard nursing care for hyperemesis gravidarum without Vibratory Emesis Massage intervention.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in the Severity of Nausea and Vomiting Symptoms.
時間枠：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).
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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).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Maternal Demographic and Baseline Clinical Characteristics.
時間枠：Measured once at baseline during the initial participant selection and screening phase.
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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)
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Measured once at baseline during the initial participant selection and screening phase.
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Device Safety and Treatment Discomfort.
時間枠：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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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.
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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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協力者と研究者
捜査官
- 主任研究者：Siti Saidah Nasution, S.Kp., M.Kep., Sp.Mat、Universitas Sumatera Utara
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- EVM-HG-USU-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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