NCT06459882

Brief Summary

The study is a randomised controlled experimental study conducted to examine the effect of progressive relaxation exercises on dyspnea and comfort level in individuals with chronic obstructive pulmonary disease. The study was conducted between January and August 2023 in the Internal Medicine Clinic of Izmir Urla State Hospital. Stratified and block randomisation method was used in the study and 42 patients, 21 intervention group and 21 control group, were completed. Patients in the intervention group received 30-minute progressive relaxation exercises for 6 weeks. Patients in the control group did not receive any intervention other than standard care practices. The data of the study were collected by face-to-face interview method using the Descriptive Information Form, Medical Research Council Dyspnea Scale, General Comfort Scale-Short Form and Patient Follow-up Form. Descriptive statistics, Shapiro Wilk test, Levene's test, Mauchly's W test, independent sample T test, Mann Whitney U test, dependent sample t test, Wilcoxon Signed Ranks test, Friedman test, Benferoni test and Fisher's Exact test were used to analyse the data obtained from the study. It was determined that the mean dyspnea level scores of the patients in the intervention group at week 6 were lower than the control group and this difference between the groups was statistically significant (p\<0.05). It was determined that the decrease in the mean comfort level scores of the patients in the intervention group according to the follow-up periods was statistically significant (p\<0.05). According to the results of the study, progressive relaxation exercises can be recommended as an effective nursing intervention to provide dyspnea management in patients with COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
Last Updated

June 17, 2024

Status Verified

June 1, 2024

Enrollment Period

8 months

First QC Date

June 11, 2024

Last Update Submit

June 14, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • dyspnea level

    Medical Research Council Scale: MMRC is an easily applicable 5-item scale that shows similar results with lung function tests and arterial blood gas measurement and is recommended for use in determining the dyspnea levels of COPD patients in GOLD guidelines. The dyspnea level is graded between 0-4. A score of 0 indicates the absence of dyspnea, and an increase in the rating indicates an increase in the severity of dyspnea.

    baseline, week 3, and week 6

  • comfort level

    The scale consists of 28 items and three sub-dimensions: relief (9 items), relaxation (9 items) and overcoming problems (10 items). The lowest value of 1 indicates a low comfort level and the highest value of 6 indicates a high comfort level. In this study, the Cronbach alpha reliability coefficient of the scale was 0.74 for the intervention group and 0.82 for the control group.

    baseline, week 3, and week 6

Study Arms (2)

progressive relaxation exercises

EXPERIMENTAL

Patients in the intervention group received 30-minute progressive relaxation exercises for 6 weeks.

Behavioral: progressive relaxation exercises

control

NO INTERVENTION

Patients in the control group did not receive any intervention other than standard care practices.

Interventions

Patients in the intervention group received 30-minute progressive relaxation exercises for 6 weeks

progressive relaxation exercises

Eligibility Criteria

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

You may qualify if:

  • years of age and over
  • Inpatient treatment in the Internal Medicine Clinic of Izmir Urla State Hospital
  • Standardised Mini Mental Test score ≥24
  • Dyspnea severity ≥2 according to the MMRC dyspnoea scale
  • Diagnosed with Stage II and Stage III COPD according to GOLD criteria
  • Functional competence to participate in progressive relaxation exercises
  • Able to access and use a smartphone
  • COPD patients who agreed to participate in the study.

You may not qualify if:

  • Have any speech and hearing problems
  • Lung disease other than COPD, physical dependence and psychiatric illness diagnosed with
  • COPD patients in the acute exacerbation period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Bakırcay University

Izmir, 35665, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ayşegül Çelik, PhD

    Izmir Bakircay University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof., RN, MSc, PhD

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 14, 2024

Study Start

January 1, 2023

Primary Completion

August 15, 2023

Study Completion

August 30, 2023

Last Updated

June 17, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations