COPD (Chronic Obstructive Pulmonary Disease)nursingNCT06752915
The Effect of Acupressure on Dyspnea and Anxiety Levels
A study testing acupressure application in people with COPD (Chronic Obstructive Pulmonary Disease), run by ÇİĞDEM ERGİN at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- acupressure application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- acupressure application
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressure applicationBehavioural
Acupressure massage will be applied to LI4, HT7, LU1 and ST 36 acupuncture points for 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| acupressure | Experimental | 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. Receives: Behavioral: acupressure application |
| control group | No intervention | No application will be made to the control group. Only pre-test and post-test will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of acupressure on dyspnea and anxiety in individuals with COPD
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.
Measured: through study completion, an average of 1 year
Effect of acupressure on dyspnea and anxiety in individuals with COPD
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.
Measured: through study completion, an average of 1 year
Effect of acupressure on dyspnea and anxiety in individuals with COPD
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.
Measured: 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.
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.
Measured: through study completion, an average of 1 year
KOAH'lı bireylerde uygulanan akupresürün dispne ve anksiyete üzerine etkisi
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start15 Jan 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Simple randomization was used in the study. By computer randomization, patients were divided into intervention and control groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ÇİĞDEM ERGİN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ÇİĞDEM ERGİN, Cukurova University
- Investigators
- songül k karadağ, Principal investigator, çukurova universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752915
- Sponsor's protocol ID
- 0000-0002-3458-1670
- Acronym
- nursing
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pre- and post-implementation results of intervention and control group scales (statistical analysis). Participants' descriptive characteristics and participant consent form.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06752915
- Acronym / sponsor ID
- nursing / 0000-0002-3458-1670
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ÇİĞDEM ERGİNUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Simple randomization was used in the study. By computer randomization, patients were divided into intervention and control groups.
| Arm | Type | Receives |
|---|---|---|
| acupressure | Experimental | Behavioral: acupressure applicationThe intervention group will receive acupressure at points LI4, HT7, LU1 and ST36, two minutes, once a day, 5 days a week, for 1 month. |
| control group | No intervention | –No application will be made to the control group. Only pre-test and post-test will be applied. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupressure applicationAcupressure massage will be applied to LI4, HT7, LU1 and ST 36 acupuncture points for 2 minutes. | Behavioural | acupressure |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: Yes. Pre- and post-implementation results of intervention and control group scales (statistical analysis). Participants' descriptive characteristics and participant consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
songül k karadağ principal investigator
çukurova universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure application in people with COPD (Chronic Obstructive Pulmonary Disease), run by ÇİĞDEM ERGİN at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of acupressure on dyspnea and anxiety in individuals with COPD (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.