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穴位按摩对肿瘤患者疼痛、恶心呕吐和心理健康的影响

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

自我管理的穴位按摩和治疗师施加的穴位按摩对肿瘤患者疼痛、恶心呕吐和心理健康的影响:一项三臂随机对照研究

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

96

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Yenişehir
      • Mersin、Yenişehir、土耳其(türkiye)
        • Mersin University Faculty of Nursing

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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

其他: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.

其他: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Pain intensity will be evaluated with a visual analog scale.
大体时间: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.
大体时间: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.
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Esra Çavuşoğlu, Doctorate、Mersin University
  • 首席研究员:Hilal Altundal Duru, Doctorate、Çankırı Karatekin University
  • 首席研究员:Kadir Eser、Mersin University
  • 首席研究员:Emel Sezer、Mersin University
  • 首席研究员:Vehbi Erçolak、Mersin University
  • 首席研究员:Ümmügülsüm Kılıç、Mersin University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年6月5日

初级完成 (实际的)

2023年6月5日

研究完成 (实际的)

2023年9月30日

研究注册日期

首次提交

2023年5月22日

首先提交符合 QC 标准的

2023年6月1日

首次发布 (实际的)

2023年6月12日

研究记录更新

最后更新发布 (实际的)

2026年10月2日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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