- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06857422
Dyspnea and Psychosocial Effects of Hand Fan Application in COPD Patients (COPD)
Effect of Hand Fan Applied to COPD Patients on Dyspnea, Illness Perception, Anxiety and Depression: A Double-Blind Randomized Controlled Experimental Study
This randomized controlled trial aims to evaluate the effects of hand fan application on dyspnea, illness perception, anxiety, and depression in COPD patients. A total of 56 voluntary COPD patients (28 experimental, 28 control) will be recruited from Ardahan State Hospital Chest Diseases Clinic.
Patients will be randomly assigned to the experimental or control group. The experimental group will receive a hand fan and use it for 10 minutes daily for six weeks, while the control group will receive standard care. Dyspnea, illness perception, anxiety, and depression will be assessed using the Visual Dyspnea Scale, Illness Perception Questionnaire, and Hospital Anxiety and Depression Scale at baseline and after six weeks.
Data will be analyzed using statistical software. This study is expected to contribute to the literature by evaluating a non-pharmacological intervention for COPD-related dyspnea and psychological outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ardahan
-
Ardahan, Ardahan, Turkey (Türkiye), 75000
- Derya ŞİMŞEKLİ
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Orientation and cooperation
- No communication problems
Exclusion Criteria:
- Having a COPD exacerbation in the last 4 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
hand fan application
|
Participants in the experimental group will be instructed to use a hand fan to cool their face for 10 minutes each day for a period of 6 weeks.
The fan should be held approximately 15 cm from the face, focusing on the middle area.
This intervention aims to alleviate symptoms of dyspnea and improve psychological well-being, including anxiety, depression, and illness perception.
The participants will receive daily reminders to ensure consistent application of the intervention.
|
|
Active Comparator: Control group
standard care
|
Participants in the control group will receive standard care for chronic obstructive pulmonary disease (COPD) patients.
This includes routine management and treatment as prescribed by their healthcare providers, such as medication and lifestyle recommendations.
They will not be instructed to use a hand fan or any other cooling device during the study period.
The control group will continue their regular care without any additional interventions from the research team.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnea Severity
Time Frame: Pre-intervention: Before the start of the intervention (baseline measurement).Post-intervention: After 6 weeks of intervention (final measurement).
|
The primary outcome measure of this study will be the severity of dyspnea, assessed using the Visual Analog Scale (VAS).
This scale is a subjective tool used to measure the intensity of shortness of breath experienced by participants.
|
Pre-intervention: Before the start of the intervention (baseline measurement).Post-intervention: After 6 weeks of intervention (final measurement).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Illness Perception
Time Frame: Pre-intervention: Before the start of the intervention (baseline measurement).Post-intervention: After 6 weeks of intervention (final measurement).
|
Measured using the Illness Perception Questionnaire
|
Pre-intervention: Before the start of the intervention (baseline measurement).Post-intervention: After 6 weeks of intervention (final measurement).
|
|
Anxiety and Depression
Time Frame: Pre-intervention: Before the start of the intervention (baseline measurement).Post-intervention: After 6 weeks of intervention (final measurement).
|
Measured using the Hospital Anxiety and Depression Scale (HADS)
|
Pre-intervention: Before the start of the intervention (baseline measurement).Post-intervention: After 6 weeks of intervention (final measurement).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Behavioral Symptoms
- Respiratory Tract Diseases
- Lung Diseases
- Respiration Disorders
- Lung Diseases, Obstructive
- Signs and Symptoms, Respiratory
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Pulmonary Disease, Chronic Obstructive
- Anxiety Disorders
- Depression
- Dyspnea
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Quality of Health Care
- Quality Indicators, Health Care
- Standard of Care
Other Study ID Numbers
- ArdahanU-Simsekli-DS-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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