- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06752915
The Effect of Acupressure on Dyspnea and Anxiety Levels (nursing)
December 20, 2024 updated by: ÇİĞDEM ERGİN
The Aim of This Study is to Determine the Effect of Acupressure Applied to Individuals with COPD on Dyspnea and Anxiety: It is Important for the Transfer of Nonpharmacological Methods to Clinical Applications
The aim of this study is to determine the effect of acupressure applied to individuals with COPD on dyspnea and anxiety.
It is important for the transfer of nonpharmacological methods to clinical applications.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The pathophysiological changes that occur in the airways and alveoli in chronic obstructive pulmonary disease can cause many symptoms such as dyspnea, cough and sputum, which restrict the daily lives of individuals.
Dyspnea and anxiety are at the top of the list among these symptoms, which affect individuals in many ways and limit them in many areas.
While physiological, psychological and sociological factors cause dyspnea, the anxiety that develops in patients along with dyspnea also accompanies the symptoms.
These symptoms seen in individuals with COPD not only negatively affect the quality of life of individuals, but also bring about psychological, cognitive, economic and social problems.
Therefore, reducing anxiety and dyspnea in patients with COPD is of great importance in controlling the symptoms.
Recently, acupressure has been frequently preferred among non-pharmacological methods in symptom control.
As a result of studies conducted with different patient groups in the literature, it has been stated that acupressure reduces dyspnea and anxiety levels.
In this study, five tools will be used: Patient Identification Form, Modified Borg Dyspnea Scale (MBS), Medical Research Council (MRC) Dyspnea Scale, Beck Anxiety Scale (BAÖ) and Patient Follow-up Schedule.
Individuals will be applied acupressure once a day for two minutes at LI4, HT7, LU1, ST36 points, for a total of 20 sessions.
It is of great importance for nurses to follow current care methods, include them in nursing care and improve themselves in this regard.
No current study has been found in the literature investigating the effect of acupressure applied to individuals with COPD on dyspnea and anxiety.
The purpose of this study is to determine the effect of acupressure applied to individuals with COPD on dyspnea and anxiety.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Adana, Turkey
- Çukurova University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Patients who are literate,
Have moderate and severe stage COPD according to GOLD criteria,
Score 8 and above on the Beck Anxiety Inventory,
Patients who volunteer to participate in the study will be included in the study.
Exclusion Criteria:
- Patients using psychiatric medication (anxiolytic, antidepressant), Those with serious pulmonary, cardiological or malignant diseases, Those with vision and hearing problems, Those with communication problems, Those with nerve, soft tissue and vascular diseases in the areas where acupressure will be applied, Those with infections and surgical operations in the areas where acupressure will be applied, Patients in the exacerbation period were not included in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: acupressure
The intervention group will receive acupressure at points LI4, HT7, LU1 and ST36, two minutes, once a day, 5 days a week, for 1 month.
|
Acupressure massage will be applied to LI4, HT7, LU1 and ST 36 acupuncture points for 2 minutes.
|
|
No Intervention: control group
No application will be made to the control group.
Only pre-test and post-test will be applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of acupressure on dyspnea and anxiety in individuals with COPD
Time Frame: through study completion, an average of 1 year
|
The Modified Borg Dyspnea Scale (MBS) was developed in 1982 by Gunnar Borg to define the intensity of physical activity.
The original Borg scale is scored between 6-20.
In 1986, the "American College of Sports Medicine" revised the scale by scoring between 0-10.
Although the Modified Borg Scale is frequently used today to define the severity of exertional dyspnea, it is also a scale that can be used to evaluate the severity of resting dyspnea.
The fact that there are various definitions in the Modified Borg Scale (MBS) makes it easier for patients to apply.
|
through study completion, an average of 1 year
|
|
Effect of acupressure on dyspnea and anxiety in individuals with COPD
Time Frame: through study completion, an average of 1 year
|
Medical Research Council Dyspnea Scale (MRC) The Medical Research Council (MRC) Dyspnea Scale was first used by Fletcher in 1952 to compare the severity of dyspnea during activity in people with and without lung disease.
Later, the British Medical Research Council (MRC) introduced this scale in a more developed form to monitor the natural course of the disease.
The dyspnea scale was created based on various physical activities that cause dyspnea.
It consists of a total of 5 items and is a 1-5 point scale.
The patient reads the scale options and selects the most appropriate degree that describes respiratory distress.
In the MRC dyspnea scale, 1 describes the best dyspnea and 5 describes the worst.
High scores on the scale indicate that the severity of shortness of breath is high.
|
through study completion, an average of 1 year
|
|
Effect of acupressure on dyspnea and anxiety in individuals with COPD
Time Frame: through study completion, an average of 1 year
|
Beck Anxiety Inventory The Beck Anxiety Inventory is a three-point Likert-type assessment scale consisting of 21 items that measures the frequency of anxiety symptoms experienced by an individual (0=none, 1=mild, 2=moderate, 3=severe).
The highest score that can be obtained from the scale is 63.
The high total score indicates the severity of anxiety.
A score between 0-7 indicates "minimal anxiety", 8-15 indicates "mild anxiety", 16-25 indicates "moderate anxiety", and 26-63 indicates "severe anxiety".
The scale was developed by Beck and his colleagues in 1988 and its validity and reliability in Turkish were performed by Ulusoy, Şahin, and Erkmen in 1996, and the Cronbach's α value was reported to be 0.93.
|
through study completion, an average of 1 year
|
|
Effect of acupressure on dyspnea and anxiety in individuals with COPDThe schedule was prepared for the intervention group and will be used throughout the intervention.
Time Frame: through study completion, an average of 1 year
|
Patient Follow-up Schedule Patients in the intervention group were followed up by phone calls every week to ensure regular and continuous acupressure application.
The patient follow-up schedule was created by the researcher to record any problems with acupressure application and to provide the necessary information.
|
through study completion, an average of 1 year
|
|
KOAH'lı bireylerde uygulanan akupresürün dispne ve anksiyete üzerine etkisi
Time Frame: through study completion, an average of 1 year
|
The Modified Borg Dyspnea Scale (MBS) was developed in 1982 by Gunnar Borg to define the intensity of physical activity.
The original Borg scale is scored between 6-20.
In 1986, the "American College of Sports Medicine" revised the scale by scoring between 0-10.
Although the Modified Borg Scale is frequently used today to define the severity of exertional dyspnea, it is also a scale that can be used to evaluate the severity of resting dyspnea.
The fact that there are various definitions in the Modified Borg Scale (MBS) makes it easier for patients to apply.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: songül k karadağ, Cukurova Universty
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2024
Primary Completion (Estimated)
January 30, 2025
Study Completion (Estimated)
June 15, 2025
Study Registration Dates
First Submitted
December 9, 2024
First Submitted That Met QC Criteria
December 20, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 20, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000-0002-3458-1670
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Pre- and post-implementation results of intervention and control group scales (statistical analysis).
Participants' descriptive characteristics and participant consent form.
IPD Sharing Time Frame
Once published, the data is available indefinitely.
IPD Sharing Access Criteria
data can be shared publicly.
IPD Sharing Supporting Information Type
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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