Lung CancerNCT05887986
Management of Dyspnea: Use of Hand Held Fan
A study testing hand-held fan airflow stimulation in people with Lung Cancer, run by Aysegul Celik at 1 site in Turkey (Türkiye).
Trial summary
This research is planned as a randomized controlled experimental study to determine the effect of air stimulation to the face with a hand fan in the management of dyspnea in lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- hand-held fan airflow stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Dec 2022to 15 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- Diagnosed with lung cancer
- mMRC dyspnea scale score ≥2
- ECOG Performance Score score ≥3
- Volunteered to participate in the research
Who cannot join
- Having a fever of 38⁰C and above in the last 24 hours
- Inability to communicate cognitively and verbally
- Having a psychiatric illness
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Provincial Health Directorate Health Sciences University Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital
Izmir
About this study
Official title: Management of Pulmonary Toxicity-related Dyspnea: Effect of Hand-held Fan Airflow Stimulation
This research is planned as a randomized controlled experimental study to determine the effect of air stimulation to the face with a hand fan in the management of dyspnea in lung cancer patients. The universe of the research was carried out between December 2022 and February 2024, Izmir Provincial Health Directorate, University of Health Sciences, Suat Seren Chest Diseases and Surgery Training and Research Hospital will consist of cancer patients. Individuals who meet the sampling selection criteria from the specified universe will constitute the sample of the research. The sample number of the research was determined as a result of the power analysis made with the G*power program. As a result of the power analysis, based on the t-test in independent groups, the minimum number of samples to be taken was 27 people for a group with 1:1 ratio, 0.80 power, effect value 0.80 and 0.05 significance level. Randomization of the sample will be ensured by accepting the first patient who applied to the outpatient chemotherapy unit randomly and with an appointment at the beginning of the study to the experimental group, and the next patient to the control group. Considering the losses, it is planned to work with 60 people, 30 people in the intervention group and 30 people in the control group. Individual Descriptive Information Form, Medical Research Council Scale (mMRC), Cancer Dyspnea Scale, Vital Signs Follow-up Form, Eastern Cooperative Oncology Group (ECOG) Performance Scale and General Comfort Scale Short Form will be used.
- Conditions
- Lung Cancer
- Being tested
- hand-held fan airflow stimulation
- Keywords
- lung cancer, dyspnea, fan therapy, comfort, oncology nursing
- Medical subject headings
- Lung Neoplasms, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand-held fan airflow stimulationOther
Outcome dyspnea measures:
After the fan training application given to the hand-held fan airflow stimulation group by the researchers, the hand fan application will be made for 5 days. On the "baseline", "day 3", and "day 5" of the study, the dyspnea level will be evaluated.
Outcome comfort measures:
After the fan training application given to the hand-held fan airflow stimulation group by the researchers, the hand fan application will be made for 5 days. On the "baseline", "day 3", and "day 5" of the study, the comfort level of the patients will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| hand-held fan airflow stimulation | Experimental | Not described Receives: Other: hand-held fan airflow stimulation |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
dyspnea level
Cancer Dyspnea Scale: It will be used to evaluate dyspnea level of cancer patient. The scale was developed by Tanaka et al (2000); An adaptation study for Turkish society was made by Bitek and Tokem (2021). The scale consists of 12 items and three dimensions (effort, anxiety, feelings of discomfort). Cronbach's alpha coefficients varying between 0.81 and 0.93 were reported for all three sub-dimensions. Three sub-dimensions and total score values are used in the evaluation of the scale. The scale is scored likert type and 1: None; 2: a little; 3: Quite; 4: Significantly; 5: Shows Too Many expressions. The total score obtained from the scale is 48. The increase in the total score obtained from the scale indicates the increase in the severity of dyspnea.
Measured: baseline, day 3, and day 5
Secondary outcomes (1)
comfort level
General Comfort Scale- Short Form: It was developed by Kolcaba in 2006. The validity and reliability study in our country was carried out by Sarıtaş et al (2018). The scale includes the sub-dimensions of comfort, relief (1-9 items), relaxation (9-18 items) and overcoming problems (1-28 items) from 28 items. These items are evaluated as Likert type ranging from "strongly disagree (1) to "strongly agree (6)". The average value is found by dividing the total score obtained by the number of scale items. The lowest value that can be taken is 1, which indicates a low level of comfort, and the highest value of 6 indicates a high level of comfort. The Cronbach alpha value of the scale was found to be 0.82
Measured: baseline, day 3, and day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start22 Dec 2022
- Primary completion9 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Randomized controlled experimental study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aysegul Celik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aysegul Celik, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887986
- Sponsor's protocol ID
- BU
- Status last verified
- Jun 2024
- First submitted
- 18 Apr 2023
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Pulmonary Toxicity-related Dyspnea: Effect of Hand-held Fan Airflow Stimulation
- ClinicalTrials.gov ID
- NCT05887986
- Acronym / sponsor ID
- BU
- Conditions
- Lung Cancer
- Keywords
- lung cancer, dyspnea, fan therapy, comfort, oncology nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Aysegul CelikUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 5 Jun 2023 (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.
This research is planned as a randomized controlled experimental study to determine the effect of air stimulation to the face with a hand fan in the management of dyspnea in lung cancer patients. The universe of the research was carried out between December 2022 and February 2024, Izmir Provincial Health Directorate, University of Health Sciences, Suat Seren Chest Diseases and Surgery Training and Research Hospital will consist of cancer patients. Individuals who meet the sampling selection criteria from the specified universe will constitute the sample of the research. The sample number of the research was determined as a result of the power analysis made with the G*power program. As a result of the power analysis, based on the t-test in independent groups, the minimum number of samples to be taken was 27 people for a group with 1:1 ratio, 0.80 power, effect value 0.80 and 0.05 significance level. Randomization of the sample will be ensured by accepting the first patient who applied to the outpatient chemotherapy unit randomly and with an appointment at the beginning of the study to the experimental group, and the next patient to the control group. Considering the losses, it is planned to work with 60 people, 30 people in the intervention group and 30 people in the control group. Individual Descriptive Information Form, Medical Research Council Scale (mMRC), Cancer Dyspnea Scale, Vital Signs Follow-up Form, Eastern Cooperative Oncology Group (ECOG) Performance Scale and General Comfort Scale Short Form will be used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| hand-held fan airflow stimulation | Experimental | Other: hand-held fan airflow stimulation |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years and older
- Diagnosed with lung cancer
- mMRC dyspnea scale score ≥2
- ECOG Performance Score score ≥3
- Volunteered to participate in the research
Key exclusion criteria (3 listed)
- Having a fever of 38⁰C and above in the last 24 hours
- Inability to communicate cognitively and verbally
- Having a psychiatric illness
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-held fan airflow stimulationOutcome dyspnea measures: After the fan training application given to the hand-held fan airflow stimulation group by the researchers, the hand fan application will be made for 5 days. On the "baseline", "day 3", and "day 5" of the study, the dyspnea level will be evaluated. Outcome comfort measures: After the fan training application given to the hand-held fan airflow stimulation group by the researchers, the hand fan application will be made for 5 days. On the "baseline", "day 3", and "day 5" of the study, the comfort level of the patients will be evaluated. | Other | hand-held fan airflow stimulation |
Primary outcome
dyspnea level
Time frame: baseline, day 3, and day 5
Cancer Dyspnea Scale: It will be used to evaluate dyspnea level of cancer patient. The scale was developed by Tanaka et al (2000); An adaptation study for Turkish society was made by Bitek and Tokem (2021). The scale consists of 12 items and three dimensions (effort, anxiety, feelings of discomfort). Cronbach's alpha coefficients varying between 0.81 and 0.93 were reported for all three sub-dimensions. Three sub-dimensions and total score values are used in the evaluation of the scale. The scale is scored likert type and 1: None; 2: a little; 3: Quite; 4: Significantly; 5: Shows Too Many expressions. The total score obtained from the scale is 48. The increase in the total score obtained from the scale indicates the increase in the severity of dyspnea.
1 secondary outcome
comfort level
Time frame: baseline, day 3, and day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
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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-held fan airflow stimulation in people with Lung Cancer, run by Aysegul Celik 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 17 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
dyspnea level (time frame: baseline, day 3, and day 5). 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 17 Jun 2024.