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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05898880
• Other study ID #: mERSINuU.
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 5, 2023
• Est. completion date: August 24, 2023

Study information

• Verified date: June 2023
• Source: Mersin University
• Contact: Esra Çavusoglu, Doctorate
• Phone: +90324 361 00 01
• Email: esracavusoglu[@]mersin.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 93
• Est. completion date: August 24, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Self-acupressure
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
• Acupressure by therapists
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
No intervention will be made in the control group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mersin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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