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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self acupressure group | Experimental | 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). |
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| Acupressure by therapist | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-acupressure | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity will be evaluated with a visual analog scale. | 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. | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esra Çavuşoğlu, Doctorate | Contact | +90324 361 00 01 | 14238 | esracavusoglu@mersin.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Esra Çavuşoğlu, Doctorate | Mersin University | Study Director |
| Hilal Altundal Duru, Doctorate | Çankırı Karatekin University | Principal Investigator |
| Kadir Eser |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010549 | Personal Satisfaction |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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This is a prospective, three-armed (1:1:1), randomized controlled experimental single-blind clinical trial.
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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.
| Control group |
| Other |
The control group will receive the routine treatment applied in the hospital, and acupressure will not be applied to this group. |
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| Acupressure by therapists | Other | 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. |
|
| Control group | Other | No intervention will be made in the control group. |
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| Mersin University |
| Principal Investigator |
| Emel Sezer | Mersin University | Principal Investigator |
| Vehbi Erçolak | Mersin University | Principal Investigator |
| Ümmügülsüm Kılıç | Mersin University | Principal Investigator |
| D001519 | Behavior |
| D008722 | Methods |