Management of Dyspnea: Use of Hand Held Fan

June 14, 2024 updated by: Aysegul Celik

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Izmir, Turkey
        • Izmir Provincial Health Directorate Health Sciences University Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years and older
  • Diagnosed with lung cancer
  • mMRC dyspnea scale score ≥2
  • ECOG Performance Score score ≥3
  • Volunteered to participate in the research

Exclusion Criteria:

  • Having a fever of 38⁰C and above in the last 24 hours
  • Inability to communicate cognitively and verbally
  • Having a psychiatric illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Experimental: hand-held fan airflow stimulation
Other: hand-held fan airflow stimulation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, day 3, and day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comfort level
Time Frame: baseline, day 3, and day 5
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
baseline, day 3, and day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aysegul Celik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2022

Primary Completion (Actual)

February 9, 2024

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 14, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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