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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Adana, Turkey
        • Cukurova 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: acupressure application
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ÇİĞDEM ERGİN

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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