NCT05884450

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

May 22, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

May 8, 2023

Last Update Submit

May 22, 2023

Conditions

Keywords

AcupressurePalliative CareDyspneaNursing

Outcome Measures

Primary Outcomes (18)

  • 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.

    Baseline

  • 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.

    Baseline

  • 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.

    2nd day

  • 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.

    3th day

  • 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.

    4th day

  • 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.

    5th day

  • 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.

    6th day

  • 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.

    7th day

  • 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.

    8th day

  • 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.

    9th day

  • 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.

    10th day

  • 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.

    11th day

  • 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.

    12th day

  • 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.

    13th day

  • 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.

    14th day

  • 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.

    Baseline

  • 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.

    7th Day

  • 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.

    14th Day

Study Arms (2)

Experiment

EXPERIMENTAL

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).

Other: Acupressure

Control

NO INTERVENTION

No application will be made to the control group.

Interventions

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.

Experiment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dilek Yildirim

Istanbul, Küçükçekmece, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dyspnea

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2023

First Posted

June 1, 2023

Study Start

May 22, 2023

Primary Completion

August 30, 2023

Study Completion

October 30, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations