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

Not Applicable

Not yet recruiting

• Conditions: Pain; Mental Health Wellness 1; Nausea With Vomiting Chemotherapy-Induced

• Registration Number: NCT05898880
• Lead Sponsor: Mersin University

Brief 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.

Study Timeline

• Study First Submitted: 2023-05-22
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-01
• Last Update Submitted: 2023-06-01
• Study Start: 2023-06-05
• Study First Posted: 2023-06-12
• Last Update Posted: 2023-06-12
• Primary Completion: 2023-07-31
• Study Completion: 2023-08-24

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain intensity will be evaluated with a visual analog scale.	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.	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.	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).