NCT06265831

Brief Summary

Diagnosing and managing dyspnea in patients with COPD is very important. Although pharmacological and non-pharmacological methods are used in the management of dyspnea, it is recommended that pharmacological methods be supported by non-pharmacological methods. Hand fan application, which is one of the non-pharmacological methods used in dyspnea management, provides an increase in self-efficacy in patients in addition to the stimulation of cold air flow to the trigeminal nerve branches, mucosa and skin. Although there are studies reporting that applying cold air to the face with a hand fan is effective in reducing the severity of dyspnea in different patient groups, the number of studies examining the effectiveness of applying cold air to the face with a hand fan in patients with COPD is quite limited. This project was planned to determine the effect of applying cold air to the face with a fan on the severity of dyspnea and quality of life in COPD patients.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

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

April 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

8 months

First QC Date

February 10, 2024

Last Update Submit

June 15, 2024

Conditions

Keywords

dyspneaCOPDquality of life

Outcome Measures

Primary Outcomes (1)

  • Modified Borg Scale

    The Modified Borg Scale was first developed to measure the effort expended during physical exercise. Later, MBS was revised in 1982 and became a scale consisting of 12 items that diagnose the severity of dyspnea according to its degree. As the points on the scale increase, the severity of dyspnea increases (0: None, 0.5: Very very mild, 1: Very mild, 2: Mild, 3: Moderate, 4: Somewhat severe, 5: Severe, 6: 7: Very severe, 8: ….., 9: Very very serious, 10: Maximum). Although MBS was first used to define the severity of exertional dyspnea, it is now also used to evaluate the severity of resting dyspnea.

    a week (seven days)

Secondary Outcomes (1)

  • Saint George Respiratory Questionnaire

    a week (seven days)

Study Arms (2)

Hand-fan application to the face

EXPERIMENTAL

At the first meeting of the hand-fan application to the face group, the Patient Identification Form, Vital Signs Form, Modified Borg Scale, and Saint George Respiratory Questionnaire Form will be filled out. Afterward, training will be given (accompanied by an academic advisor) on how to apply cold air to the face with a hand fan (3 times a day for 5 minutes) for dyspnea management. Additionally, patients will be given a hand-fan application brochure. The researchers will monitor the patient every day for a week (7 days), fill out the vital signs form, and the final test will be administered by the researchers on the 8th day.

Other: Hand-fan application to the face

Standard care group

NO INTERVENTION

In the standard care group, the Patient Diagnosis Form, Vital Signs Form, Modified Borg Scale, and Saint George Respiratory Questionnaire Form will be filled in at the first interview. The clinic's routine care protocol will be applied to the patients in the control group, and the researchers will fill out a vital signs form every day for a week, and the patients will be followed up.

Interventions

Hand fan application is one of the applications recommended in managing dyspnea in evidence-based guidelines. Hand fan application effectively reduces shortness of breath by stimulating cold airflow to the 2nd and 3rd trigeminal nerve branches, mucosa, and skin.

Hand-fan application to the face

Eligibility Criteria

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

You may qualify if:

  • Having been diagnosed with COPD at least 6 months ago,
  • Being over 18 years of age,
  • No open wounds on the face for any reason,
  • Lung cancer, tuberculosis, asthma etc. absence of other respiratory system diseases,
  • Not having a hearing or speech impairment,
  • Not having a cognitive disability
  • Volunteering to participate in the research.

You may not qualify if:

  • Being diagnosed with COPD less than 6 months ago,
  • Being under 18 years of age,
  • Having an open wound on the face for any reason,
  • Lung cancer, tuberculosis, asthma etc. Having other respiratory system diseases,
  • Having hearing and speech impairment,
  • Having a cognitive disability
  • Not volunteering to participate in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmiye ÇÖMLEKÇİ

Bartın, 74100, 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Hospitalized patients with a diagnosis of COPD will be randomized into two groups. The intervention group will have a hand fan applied to the face and be monitored for a week, and the control group will receive routine care at the clinic. Investigators will evaluate outcome measures.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel group: two groups, an intervention group and a control group, receiving complementary therapy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, PhD

Study Record Dates

First Submitted

February 10, 2024

First Posted

February 20, 2024

Study Start

April 1, 2023

Primary Completion

November 30, 2023

Study Completion

June 1, 2024

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

After the research is published as an article, the data will be shared with researchers who request it. (Personal and private information of the participants is hidden.)

Shared Documents
STUDY PROTOCOL, SAP

Locations