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The Effect of Acupressure on the Management of Dyspnea

Primary Purpose

Palliative Care, Dyspnea

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupressure
Sponsored by
Istanbul Aydın University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Palliative Care focused on measuring Acupressure, Palliative Care, Dyspnea, Nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18 years or older, Least literate, Patients with moderate to severe dyspnea (with dyspnea score of 3 or higher on a 0-10 scale in the Modified Borg Scale evaluation) will be included in the study. Exclusion Criteria: Refusal to participate in the study Finding a communication problem

Sites / Locations

  • Dilek Yildirim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experiment

Control

Arm Description

In the experimental group, acupressure will be applied to the patients by the researchers twice a day, every day for two weeks, for 3 minutes to each point (Lu1, Lu10, P6).

No application will be made to the control group.

Outcomes

Primary Outcome Measures

Patient Descriptive Information Form:
In the form prepared by the researchers; There are 20 questions about the personal characteristics of the patients and the disease, palliative care and dyspnea.
Modified Borg Scale (MBS)
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Change Modified Borg Scale (MBS)
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Change Modified Borg Scale (MBS)
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Change Modified Borg Scale (MBS)
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Change Modified Borg Scale (MBS)
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Change Modified Borg Scale (MBS)
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Change Modified Borg Scale (MBS)
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Change Modified Borg Scale (MBS)
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Change Modified Borg Scale (MBS)
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Change Modified Borg Scale (MBS)
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Change Modified Borg Scale (MBS)
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Change Modified Borg Scale (MBS)
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Change Modified Borg Scale (MBS)
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Change Modified Borg Scale (MBS)
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Functional Assessment of Chronic Illness Therapy- Palliative Care (FACIT - Pal)
The validity and reliability of the scale, which was developed by David Cella et al. in 1993 (16) with palliative care patients, was performed by Lyons et al. in 2009 (17). This assessment tool, which is used to evaluate the quality of life of palliative care patients, consists of a total of 46 statements and 5 sub-dimensions. High scores obtained from the total of the scale indicate high quality of life, and low scores indicate a decrease in quality of life.
Change Functional Assessment of Chronic Illness Therapy- Palliative Care (FACIT - Pal)
The validity and reliability of the scale, which was developed by David Cella et al. in 1993 (16) with palliative care patients, was performed by Lyons et al. in 2009 (17). This assessment tool, which is used to evaluate the quality of life of palliative care patients, consists of a total of 46 statements and 5 sub-dimensions. High scores obtained from the total of the scale indicate high quality of life, and low scores indicate a decrease in quality of life.
Change Functional Assessment of Chronic Illness Therapy- Palliative Care (FACIT - Pal)
The validity and reliability of the scale, which was developed by David Cella et al. in 1993 (16) with palliative care patients, was performed by Lyons et al. in 2009 (17). This assessment tool, which is used to evaluate the quality of life of palliative care patients, consists of a total of 46 statements and 5 sub-dimensions. High scores obtained from the total of the scale indicate high quality of life, and low scores indicate a decrease in quality of life.

Secondary Outcome Measures

Full Information

First Posted
May 8, 2023
Last Updated
May 22, 2023
Sponsor
Istanbul Aydın University
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1. Study Identification

Unique Protocol Identification Number
NCT05884450
Brief Title
The Effect of Acupressure on the Management of Dyspnea
Official Title
The Effect of Acupressure on the Management of Dyspnea in Palliative Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 22, 2023 (Anticipated)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Aydın 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
Dyspnea can develop at any stage of the disease, but it is more common in the last period of life. Complementary and integrative methods used for dyspnea symptoms include acupuncture, acupressure, visualization techniques, herbal treatments, nutritional supplements, stress management, relaxation techniques, exercise, breathing training and psychotherapy, etc. There are studies in the literature showing that acupuncture and acupressure are effective in controlling dyspnea symptoms in various disease groups. Acupressure is an integrated method of applying physical pressure to acupuncture points on the body surface with hands, elbows or various tools. With good counseling, patients can apply this method, which is non-invasive, easy to apply, and safe. Reducing the psychological stress that causes dyspnea along with dyspnea is important for symptom management. It has been reported that acupressure application has significant effects especially in dyspnea that develops with exertion. It is seen that studies on the subject are not sufficient in terms of quantity and quality in terms of giving advice to patients, and there is a need for well-planned studies with high power. The aim of this study; The aim of this study is to determine the effect of acupressure applied to three acupuncture points (Lu1, Lu10, P6) on the arm and chest in palliative care patients with dyspnea on dyspnea level and quality of life, twice a day for 4 weeks, for 3 minutes to each point.
Detailed Description
Dyspnea can develop at any stage of the disease, but it is more common in the last period of life (1). In different studies, the incidence of dyspnea in patients receiving palliative care with the diagnosis of lung cancer was reported to be 57-90%, 60% in esophageal cancer, and 46% in breast cancer (1-5). In a study, it was shown that 65% of palliative care patients died with dyspnea in the last three months of their lives (6). There may be many reasons that trigger the development of dyspnea in palliative care patients. In addition to primary or metastatic lung involvement, antineoplastic therapy, thoracic irradiation, obstruction caused by mediastinal tumor, pleural effusion and pulmonary embolism may also cause dyspnea. In addition, dyspnea in these patients may be due to existing chronic obstructive pulmonary disease, pulmonary embolism, hepatomegaly, acidity, anemia that can affect the patient's respiration, cachexia, anxiety, or thoracic surgery (7). Regardless of the cause, as a result, dyspnea is one of the important complaints that negatively affects the patient's quality of life and reminds patients of death. Since dyspnea is a multifaceted subjective condition that affects the patient physiologically, psychologically, socially and environmentally, comprehensive diagnosis and early planning of effective approaches in its management are important for patients to complete a good palliative care process (8-10). Complementary and integrative methods used for dyspnea symptoms include acupuncture, acupressure, visualization techniques, herbal treatments, nutritional supplements, stress management, relaxation techniques, exercise, breathing training and psychotherapy, etc. (11,12) There are studies in the literature showing that acupuncture and acupressure are effective in controlling dyspnea symptoms in various disease groups (13,14). Acupressure is an integrated method of applying physical pressure to acupuncture points on the body surface with hands, elbows or various tools. With good counseling, patients can apply this method, which is non-invasive, easy to apply, and safe (13). Reducing the psychological stress that causes dyspnea along with dyspnea is important for symptom management (10). It has been reported that acupressure application has significant effects especially in dyspnea that develops with exertion (14). It is seen that studies on the subject are not sufficient in terms of quantity and quality in terms of giving advice to patients, and there is a need for well-planned studies with high power. The aim of this study; The aim of this study is to determine the effect of acupressure applied to three acupuncture points (Lu1, Lu10, P6) on the arm and chest in palliative care patients with dyspnea on dyspnea level and quality of life, twice a day for 4 weeks, for 3 minutes to each point. Method: Purpose and Type of Study: The aim of the study, which will be conducted in randomized controlled parallel group, experimental research design type, is to determine the effect of acupressure on dyspnea level and quality of life in palliative care patients with dyspnea symptoms. Variables of the Study Independent Variable: Socioeconomic and disease-related characteristics (age, gender, diagnosis, length of hospital stay, etc.). Dependent Variable: Quality of Life, level of dyspnea, vital signs. Intervention to be Implemented In the experimental group, acupressure will be applied to the patients by the researchers twice a day, every day for two weeks, for 3 minutes to each point (Lu1, Lu10, P6). No application will be made to the control group. Respiratory rate, rhythm, blood pressure, heart rate and Borg Scale Score will be evaluated and recorded for 14 days before and after acupressure application. On the 7th and 14th days, the FACIT - Pal (Functional Assessment of Chronic Illness Therapy- Palliative care) Quality of Life Scale will be filled again.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palliative Care, Dyspnea
Keywords
Acupressure, Palliative Care, Dyspnea, Nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled experimental study
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiment
Arm Type
Experimental
Arm Description
In the experimental group, acupressure will be applied to the patients by the researchers twice a day, every day for two weeks, for 3 minutes to each point (Lu1, Lu10, P6).
Arm Title
Control
Arm Type
No Intervention
Arm Description
No application will be made to the control group.
Intervention Type
Other
Intervention Name(s)
Acupressure
Intervention Description
Acupressure is an integrated method of applying physical pressure to acupuncture points on the body surface with hands, elbows or various tools. With good counseling, patients can apply this method, which is non-invasive, easy to apply and safe, on their own.
Primary Outcome Measure Information:
Title
Patient Descriptive Information Form:
Description
In the form prepared by the researchers; There are 20 questions about the personal characteristics of the patients and the disease, palliative care and dyspnea.
Time Frame
Baseline
Title
Modified Borg Scale (MBS)
Description
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Time Frame
Baseline
Title
Change Modified Borg Scale (MBS)
Description
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Time Frame
2nd day
Title
Change Modified Borg Scale (MBS)
Description
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Time Frame
3th day
Title
Change Modified Borg Scale (MBS)
Description
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Time Frame
4th day
Title
Change Modified Borg Scale (MBS)
Description
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Time Frame
5th day
Title
Change Modified Borg Scale (MBS)
Description
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Time Frame
6th day
Title
Change Modified Borg Scale (MBS)
Description
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Time Frame
7th day
Title
Change Modified Borg Scale (MBS)
Description
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Time Frame
8th day
Title
Change Modified Borg Scale (MBS)
Description
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Time Frame
9th day
Title
Change Modified Borg Scale (MBS)
Description
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Time Frame
10th day
Title
Change Modified Borg Scale (MBS)
Description
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Time Frame
11th day
Title
Change Modified Borg Scale (MBS)
Description
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Time Frame
12th day
Title
Change Modified Borg Scale (MBS)
Description
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Time Frame
13th day
Title
Change Modified Borg Scale (MBS)
Description
The first version of the MBS was developed in 1970 by Gunnar Borg to measure the effort expended during physical exercise. The scale was rearranged in 1982 and turned into a scale consisting of 12 items diagnosing the severity of dyspnea according to their degrees (15). As the scores on the scale increase, the severity of dyspnea increases.
Time Frame
14th day
Title
Functional Assessment of Chronic Illness Therapy- Palliative Care (FACIT - Pal)
Description
The validity and reliability of the scale, which was developed by David Cella et al. in 1993 (16) with palliative care patients, was performed by Lyons et al. in 2009 (17). This assessment tool, which is used to evaluate the quality of life of palliative care patients, consists of a total of 46 statements and 5 sub-dimensions. High scores obtained from the total of the scale indicate high quality of life, and low scores indicate a decrease in quality of life.
Time Frame
Baseline
Title
Change Functional Assessment of Chronic Illness Therapy- Palliative Care (FACIT - Pal)
Description
The validity and reliability of the scale, which was developed by David Cella et al. in 1993 (16) with palliative care patients, was performed by Lyons et al. in 2009 (17). This assessment tool, which is used to evaluate the quality of life of palliative care patients, consists of a total of 46 statements and 5 sub-dimensions. High scores obtained from the total of the scale indicate high quality of life, and low scores indicate a decrease in quality of life.
Time Frame
7th Day
Title
Change Functional Assessment of Chronic Illness Therapy- Palliative Care (FACIT - Pal)
Description
The validity and reliability of the scale, which was developed by David Cella et al. in 1993 (16) with palliative care patients, was performed by Lyons et al. in 2009 (17). This assessment tool, which is used to evaluate the quality of life of palliative care patients, consists of a total of 46 statements and 5 sub-dimensions. High scores obtained from the total of the scale indicate high quality of life, and low scores indicate a decrease in quality of life.
Time Frame
14th Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years or older, Least literate, Patients with moderate to severe dyspnea (with dyspnea score of 3 or higher on a 0-10 scale in the Modified Borg Scale evaluation) will be included in the study. Exclusion Criteria: Refusal to participate in the study Finding a communication problem
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DİLEK YILDIRIM, PhD
Phone
+90 444 1 428
Ext
20114
Email
dilekaticiyildirim@gmail.com
Facility Information:
Facility Name
Dilek Yildirim
City
Istanbul
State/Province
Küçükçekmece
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effect of Acupressure on the Management of Dyspnea

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