COPDHandfanCOPDNCT06265831
The Effect of Face Hand Fan Application on Dyspnea
A study testing Hand-fan application to the face in people with COPD, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Hand-fan application to the face
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Face Hand Fan Application on Dyspnea and Quality of Life in COPD Patients
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.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a chronic disease with a high incidence both in our country and around the world. Dyspnea is one of the common problems in COPD patients. Dyspnea is an important symptom that limits patients' physical mobility, causes psychological problems such as anxiety, depression, and panic, and negatively affects their quality of life. Therefore, it is very important to diagnose and manage dyspnea in patients with COPD. 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 airflow 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.
Method: The research was planned as a randomized, controlled experimental design. The population of the research consists of patients treated with a diagnosis of COPD in Bartın State Hospital Chest Diseases Service. Considering the data obtained from a similar study, the sample was calculated as 64 patients in the intervention group and 64 patients in the control group, for a total of 128 patients. Data will be collected using the Descriptive Information Form, Vital Signs Form, Modified Borg Scale, and Saint George Respiratory Questionnaire.
Data will be collected by researchers through face-to-face interviews with COPD patients treated at Bartın State Hospital Chest Diseases Service. Patients receiving treatment with a diagnosis of COPD will be randomized into intervention and control groups. In the control 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 7 days, and the patients will be followed up. At the first meeting of the intervention 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.
- Conditions
- COPD
- Being tested
- Hand-fan application to the face
- Keywords
- dyspnea, COPD, quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand-fan application to the faceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: a week (seven days)
Secondary outcomes (1)
Saint George Respiratory Questionnaire
Saint George Respiratory Questionnaire is a survey developed to evaluate the health-related quality of life of patients diagnosed with COPD. The survey consists of 50 items and 3 main sections. These sections; symptoms (8 items), activity (16 items) and effects of the disease (26 items). The questionnaire evaluates respiratory symptoms, activities restricted due to dyspnea, and the impact of this condition on daily life. In the evaluation, the total score of the survey is distributed between 0 and 100. A score of 0 indicates that there is no deterioration in the quality of life, while a score of 100 indicates that the quality of life is increasingly negatively affected. In the reliability analysis of SGSA, Cronbach's alpha coefficient was found to be 0.88 for the entire scale.
Measured: a week (seven days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Apr 2023
- Primary completion30 Nov 2023
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group: two groups, an intervention group and a control group, receiving complementary therapy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Necmiye ÇÖMLEKÇİ, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265831
- Sponsor's protocol ID
- BU-FHS-NC-03
- Acronym
- HandfanCOPD
- Status last verified
- Jun 2024
- First submitted
- 10 Feb 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.)
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Face Hand Fan Application on Dyspnea and Quality of Life in COPD Patients
- ClinicalTrials.gov ID
- NCT06265831
- Acronym / sponsor ID
- HandfanCOPD / BU-FHS-NC-03
- Conditions
- COPD
- Keywords
- dyspnea, COPD, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- Jun 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a chronic disease with a high incidence both in our country and around the world. Dyspnea is one of the common problems in COPD patients. Dyspnea is an important symptom that limits patients' physical mobility, causes psychological problems such as anxiety, depression, and panic, and negatively affects their quality of life. Therefore, it is very important to diagnose and manage dyspnea in patients with COPD. 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 airflow 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.
Method: The research was planned as a randomized, controlled experimental design. The population of the research consists of patients treated with a diagnosis of COPD in Bartın State Hospital Chest Diseases Service. Considering the data obtained from a similar study, the sample was calculated as 64 patients in the intervention group and 64 patients in the control group, for a total of 128 patients. Data will be collected using the Descriptive Information Form, Vital Signs Form, Modified Borg Scale, and Saint George Respiratory Questionnaire.
Data will be collected by researchers through face-to-face interviews with COPD patients treated at Bartın State Hospital Chest Diseases Service. Patients receiving treatment with a diagnosis of COPD will be randomized into intervention and control groups. In the control 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 7 days, and the patients will be followed up. At the first meeting of the intervention 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel group: two groups, an intervention group and a control group, receiving complementary therapy.
| Arm | Type | Receives |
|---|---|---|
| Hand-fan application to the face | Experimental | Other: Hand-fan application to the faceAt 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand-fan application to the faceHand 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. | Other | Hand-fan application to the face |
Primary outcome
Modified Borg Scale
Time frame: a week (seven days)
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.
1 secondary outcome
Saint George Respiratory Questionnaire
Time frame: a week (seven days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: Yes. 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.)
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand-fan application to the face in people with COPD, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Borg Scale (time frame: a week (seven days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.