Clinical trial NCT05898880: The Effect of Acupressure on Pain, Nausea-Vomiting, and Mental Well-Being in Oncology Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Nausea With Vomiting Chemotherapy-Induced
Mental Health Wellness 1
Keywords: Chemotherapy
Pain
Nausea-vomiting
Mental Well-Being
Acupressure
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, three-armed (1:1:1), randomized controlled experimental single-blind clinical trial.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Pain intensity will be evaluated with a visual analog scale.
timeFrame: Change from baseline pain level at 3 days
measure: Nausea-vomiting severity will be evaluated with the Rhodes Nausea-Vomiting and Retching Index.
timeFrame: Change from baseline nausea-vomiting level at 3 days
measure: Mental well-being will be evaluated using the Warwick-Edinburgh Mental Well-Being Scale.
timeFrame: Change from baseline mental well-being level at 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mersin University
name: Esra Çavuşoğlu, Doctorate
role: STUDY_DIRECTOR
affiliation: Çankırı Karatekin University
name: Hilal Altundal Duru, Doctorate
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Kadir Eser
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Emel Sezer
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Vehbi Erçolak
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Ümmügülsüm Kılıç
role: PRINCIPAL_INVESTIGATOR
References: