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腫瘍患者の痛み、吐き気・嘔吐、精神的健康に対する指圧の効果

2026年9月29日 更新者:Esra Cavusoglu、Mersin University

腫瘍患者の疼痛、吐き気・嘔吐、および精神的健康に対する自己投与の指圧と療法士による指圧の効果:3群ランダム化対照研究

The goal of this clinical trial is to compare the effect of self acupressure and acupressure applied by therapists on pain, nausea-vomiting, and mental well-being in oncology patients.

For this purpose, 96 individuals with stage 1-stage 3 cancer will be included in the study.

The main questions it aims to answer are:

• Is acupressure effective on pain, nausea-vomiting and mental well-being in oncology patients? Is there a difference in the effectiveness of self-acupressure and acupressure applied by therapist on pain, nausea-vomiting and mental well-being? The participants will be included in the study as three groups, namely the self-acupressure group, the acupressure group applied by the therapist, and the control group.

Self-acupressure participants will self-administer acupressure. In the acupressure group, which will be applied by the therapist, acupressure will be applied to the participants by researchers who have acupressure certificate.

In the control group, acupressure etc. No additional application will be made. Visual analog scale, nausea-vomiting and retching index, and mental well-being scales will be applied to all groups at the beginning of the study and three days after the study.

調査の概要

詳細な説明

Large Intestine Meridian 4th point (Hegu/LI4), Pericardium Meridian/Neiguan (P6) point and Yintang (EX-HN 3) point will be used for acupressure application in the research.

研究の種類

介入

入学 (実際)

96

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Yenişehir
      • Mersin、Yenişehir、トルコ(Türkiye)
        • Mersin University Faculty of Nursing

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • ≥18 years
  • Cancer patients without distant metastases in stage-1, stage-2 and stage-3 who have received at least one course of chemotherapy
  • Pain degree 4 and above (will be evaluated with a visual analog scale)
  • Nausea-vomiting degree of 4 and above (will be evaluated with a visual analog scale)
  • Receiving standard antiemetic and standard analgesic treatment (All patients included in the study should receive similar treatment.)
  • No previous acupressure experience
  • Absence of any wound or lesion in the area where acupressure will be applied.
  • Not using a different complementary approach during the collection of research data
  • Those who signed the Informed Consent Form/Written Consent Form
  • Patients without any psychiatric diagnosis will be included in the study.

Exclusion Criteria:

  • < 18 years old
  • Those who have not received chemotherapy before
  • Pain grade below 4 (will be evaluated with a visual analog scale)
  • Nausea-vomiting degree below 4 (will be evaluated with a visual analog scale)
  • Receiving different antiemetic and analgesic treatments
  • Previous acupressure experience
  • Any wound or lesion in the area where acupressure will be applied
  • Using a complementary approach other than acupressure at the time research data was collected
  • Those who did not sign the Informed Consent Form/Written Consent Form
  • Patients with any psychiatric diagnosis will not be included in the study.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Self acupressure group

The first acupressure application will be administered and taught individually by the researcher to the oncology patients in the self-administered group. Afterwards, each patient who learns the application will be asked to apply acupressure on his own for three days. In the self-acupressure group, a questionnaire form consisting of a personal information form, visual analog scale, nausea, vomiting and retching index and mental well-being scale will be applied first (pre-test) before the acupressure application is taught to the group by the researchers. Afterwards, patients will apply acupressure on their own for three days, and at the end of this period (post-test), a questionnaire consisting of personal information form, visual analog scale, nausea, vomiting and retching index and mental well-being scale will be applied. Acupressure will be applied the large intestine meridian 4th Point (LI4), the pericardium meridian Neiguan (P6) and Yintang (EX-HN3).

In the self-acupressure group, before the application, the tissue sensitivity will be reduced by heating and rubbing for 20 seconds without direct pressure on the acupressure points, and the points will be made ready for acupressure application. Afterwards, sequential (breathing rhythm) compressions will be applied to the determined acupressure points by the researcher for a total of two minutes for each point without raising the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief. Two of the three different points (LI4 and P6) selected for the application will be applied symmetrically on the other extremity. Therefore, the session duration of each patient will be approximately 12 minutes, depending on the preparation and compression time on each point. Afterwards, acupressure will be applied to themselves by participants

他の:Acupressure by therapist

In this group, acupressure will be administered to stage I, stage II, and stage III cancer patients receiving at least one course of chemotherapy for a total of three days by researchers with acupressure certification. Before the application (pre-test) by the therapist, a questionnaire consisting of a personal information form, visual analog scale, nausea, vomiting and retching index and mental well-being scale will be applied to the patients in the group in question. At the end of the three-day acupressure application (post-test) applied to the patients included in the study by the therapist, a questionnaire consisting of a personal information form, visual analog scale, nausea, vomiting and retching index and mental well-being scale will be applied. In the acupressure group applied by the therapist, a total of three points will be applied to the upper extremity: the 4th point of the large intestine meridian (LI4), the Pericardium Meridian/Neiguan (P6), Yintang (EX-HN3) point.

In the acupressure group applied by therapist, before the application, the tissue sensitivity will be reduced by heating and rubbing for about 20 seconds without direct pressure on the acupressure points, and the points will be ready for acupressure application. Afterwards, sequential (breathing rhythm) compressions will be applied to the determined acupressure points by the researcher for a total of two minutes for each point without raising the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief. Two of the three different points (LI4 and P6) selected for the application will be applied symmetrically on the other extremity. Therefore, the session duration of each patient will be approximately 12 minutes, depending on the preparation and compression time on each point.

他の:Control group

The control group will receive the routine treatment applied in the hospital, and acupressure will not be applied to this group.

No intervention will be made in the control group.

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
Pain intensity will be evaluated with a visual analog scale.
時間枠:Change from baseline pain level at 3 days

The patient evaluates their own pain using a scale ranging from 1 to 10, with 1 = very mild discomfort and 10 = the most severe pain the patient can imagine. Ranges for pain intensity; <3 mild pain, 3-6 moderate pain, >6 severe pain.

Change from baseline pain level at 3 days
Nausea-vomiting severity will be evaluated with the Rhodes Nausea-Vomiting and Retching Index.
時間枠:Change from baseline nausea-vomiting level at 3 days

Each response is scored as 0 = least distress, 4 = most distress. The patient's experience of nausea and vomiting in each of the 8 items is summed up. The highest possible value is 32, indicating the most severe symptom occurrence score.

Change from baseline nausea-vomiting level at 3 days
Mental well-being will be evaluated using the Warwick-Edinburgh Mental Well-Being Scale.
時間枠:Change from baseline mental well-being level at 3 days

The scale is in the 5-point Likert type and a minimum of 14 and a maximum of 70 points are obtained from the scale. Scoring of the scale is (1 = strongly disagree, 2 = disagree, 3 = somewhat agree, 4 = agree, 5 = completely agree).

Change from baseline mental well-being level at 3 days

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Esra Çavuşoğlu, Doctorate、Mersin University
  • 主任研究者:Hilal Altundal Duru, Doctorate、Çankırı Karatekin University
  • 主任研究者:Kadir Eser、Mersin University
  • 主任研究者:Emel Sezer、Mersin University
  • 主任研究者:Vehbi Erçolak、Mersin University
  • 主任研究者:Ümmügülsüm Kılıç、Mersin University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年6月5日

一次修了 (実際)

2023年6月5日

研究の完了 (実際)

2023年9月30日

試験登録日

最初に提出

2023年5月22日

QC基準を満たした最初の提出物

2023年6月1日

最初の投稿 (実際)

2023年6月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月2日

QC基準を満たした最後の更新が送信されました

2026年9月29日

最終確認日

2026年9月1日

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