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Palliative CareNCT05884450

The Effect of Acupressure on the Management of Dyspnea

A study testing Acupressure in people with Palliative Care and Dyspnea, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Palliative Care, Dyspnea
What is being tested?
Acupressure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 May 2023to 30 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Refusal to participate in the study
  • Finding a communication problem

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Dilek Yildirim

    Istanbul, Küçükçekmece

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Acupressure on the Management of Dyspnea in Palliative Care Patients

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.

Read more

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.

Read the 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.

Being tested
Acupressure
Keywords
Acupressure, Palliative Care, Dyspnea, Nursing
Medical subject headings
Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupressureOther

    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.

Study groups in NCT05884450
Study groupRoleWhat they receive
ExperimentExperimentalIn 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).
Receives: Other: Acupressure
ControlNo interventionNo application will be made to the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: 2nd day

  4. 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.

    Measured: 3th day

  5. 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.

    Measured: 4th day

  6. 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.

    Measured: 5th day

  7. 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.

    Measured: 6th day

  8. 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.

    Measured: 7th day

  9. 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.

    Measured: 8th day

  10. 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.

    Measured: 9th day

  11. 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.

    Measured: 10th day

  12. 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.

    Measured: 11th day

  13. 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.

    Measured: 12th day

  14. 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.

    Measured: 13th day

  15. 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.

    Measured: 14th day

  16. 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.

    Measured: Baseline

  17. 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.

    Measured: 7th Day

  18. 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.

    Measured: 14th Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2023
  2. Study start22 May 2023 (estimated)
  3. Primary completion30 Aug 2023 (estimated)
  4. Study completion30 Oct 2023 (estimated)

Resources

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
Parallel groups
Model description
Randomized controlled experimental study
Masking
Single blind
Who is masked
Participant
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05884450
Sponsor's protocol ID
ACUPRESSURE DYSPNEA
Status last verified
May 2023
First submitted
8 May 2023
Last updated
1 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Acupressure in people with Palliative Care and Dyspnea, run by Istanbul Aydın University 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Jun 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact DİLEK YILDIRIM, PhD (+90 444 1 428 ext. 20114, dilekaticiyildirim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Descriptive Information Form: (time frame: Baseline). The study lists 18 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 1 Jun 2023.

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