The Effect of Acupressure on Pain, Nausea-Vomiting, and Mental Well-Being in Oncology Patients

Trial Title: The Effect of Acupressure on Pain, Nausea-Vomiting, and Mental Well-Being in Oncology Patients

NCT ID: NCT05898880

Condition: Pain
Nausea With Vomiting Chemotherapy-Induced
Mental Health Wellness 1

Conditions: Official terms:
Nausea
Vomiting

Conditions: Keywords:
Chemotherapy
Pain
Nausea-vomiting
Mental Well-Being
Acupressure

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: This is a prospective, three-armed (1:1:1), randomized controlled experimental single-blind clinical trial.

Primary purpose: Other

Masking: Single (Investigator)

Masking description: 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.

Intervention:

Intervention type: Other
Intervention name: Self-acupressure
Description: 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
Arm group label: Self acupressure group

Intervention type: Other
Intervention name: Acupressure by therapists
Description: 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.
Arm group label: Acupressure by therapist

Intervention type: Other
Intervention name: Control group
Description: No intervention will be made in the control group.
Arm group label: Control group

Summary: 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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: June 5, 2023

Completion date: August 24, 2023

Lead sponsor:
Agency: Mersin University
Agency class: Other

Source: Mersin University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05898880