NCT06752915

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 9, 2024

Last Update Submit

December 20, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    through study completion, an average of 1 year

Study Arms (2)

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.

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.

Interventions

Acupressure massage will be applied to LI4, HT7, LU1 and ST 36 acupuncture points for 2 minutes.

acupressure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • songül k karadağ

    çukurova universty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Simple randomization was used in the study. By computer randomization, patients were divided into intervention and control groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD student and nursing

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 31, 2024

Study Start

January 15, 2024

Primary Completion

January 30, 2025

Study Completion

June 15, 2025

Last Updated

December 31, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Pre- and post-implementation results of intervention and control group scales (statistical analysis). Participants' descriptive characteristics and participant consent form.

Shared Documents
ICF
Time Frame
Once published, the data is available indefinitely.
Access Criteria
data can be shared publicly.
More information

Locations