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

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-acupressure
Acupressure by therapists
Control group
Sponsored by
Mersin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain focused on measuring Chemotherapy, Pain, Nausea-vomiting, Mental Well-Being, Acupressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Other

    Other

    Arm Label

    Self acupressure group

    Acupressure by therapist

    Control group

    Arm Description

    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).

    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.

    The control group will receive the routine treatment applied in the hospital, and acupressure will not be applied to this group.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    May 22, 2023
    Last Updated
    June 1, 2023
    Sponsor
    Mersin University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05898880
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 5, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2023 (Anticipated)
    Study Completion Date
    August 24, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mersin University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Nausea With Vomiting Chemotherapy-Induced, Mental Health Wellness 1
    Keywords
    Chemotherapy, Pain, Nausea-vomiting, Mental Well-Being, Acupressure

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a prospective, three-armed (1:1:1), randomized controlled experimental single-blind clinical trial.
    Masking
    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.
    Allocation
    Randomized
    Enrollment
    93 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Self acupressure group
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Acupressure by therapist
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    The control group will receive the routine treatment applied in the hospital, and acupressure will not be applied to this group.
    Intervention Type
    Other
    Intervention Name(s)
    Self-acupressure
    Intervention 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
    Intervention Type
    Other
    Intervention Name(s)
    Acupressure by therapists
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    Control group
    Intervention Description
    No intervention will be made in the control group.
    Primary Outcome Measure Information:
    Title
    Pain intensity will be evaluated with a visual analog scale.
    Description
    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.
    Time Frame
    Change from baseline pain level at 3 days
    Title
    Nausea-vomiting severity will be evaluated with the Rhodes Nausea-Vomiting and Retching Index.
    Description
    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.
    Time Frame
    Change from baseline nausea-vomiting level at 3 days
    Title
    Mental well-being will be evaluated using the Warwick-Edinburgh Mental Well-Being Scale.
    Description
    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).
    Time Frame
    Change from baseline mental well-being level at 3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Esra Çavuşoğlu, Doctorate
    Phone
    +90324 361 00 01
    Ext
    14238
    Email
    esracavusoglu@mersin.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Esra Çavuşoğlu, Doctorate
    Organizational Affiliation
    Mersin University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Hilal Altundal Duru, Doctorate
    Organizational Affiliation
    Çankırı Karatekin University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kadir Eser
    Organizational Affiliation
    Mersin University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Emel Sezer
    Organizational Affiliation
    Mersin University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Vehbi Erçolak
    Organizational Affiliation
    Mersin University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ümmügülsüm Kılıç
    Organizational Affiliation
    Mersin University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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