The Effect of Self-Administered Acupressure and Acupressure Applied by Therapist on Pain, Nausea-Vomiting, and Mental Well-Being in Oncology Patients: A Three-Arm Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 93
- 主要终点
- Pain intensity will be evaluated with a visual analog scale.
研究概览
简要总结
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, 93 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
Patients included in the study will not be blinded as they will be in acupressure (administered by the therapist), self-acupressure or control groups.
Researchers will be blinded only during group assignment. The data will be transferred to the computer environment by the researchers, and a biostatistician independent of the research will analyze the data and report the findings without knowing which of the three groups are. Thus, the biostatistician will be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •< 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.
研究组 & 干预措施
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).
干预措施: Self-acupressure (Other)
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.
干预措施: Acupressure by therapists (Other)
Control group
The control group will receive the routine treatment applied in the hospital, and acupressure will not be applied to this group.
干预措施: Control group (Other)
结局指标
主要结局
Pain intensity will be evaluated with a visual analog scale.
时间窗: 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.
Nausea-vomiting severity will be evaluated with the Rhodes Nausea-Vomiting and Retching Index.
时间窗: 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.
Mental well-being will be evaluated using the Warwick-Edinburgh Mental Well-Being Scale.
时间窗: 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).
次要结局
未报告次要终点
研究者
Esra Cavusoglu
Principal Investigator
Mersin University