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Management of Dyspnea: Use of Hand Held Fan

Primary Purpose

Lung Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
hand-held fan airflow stimulation
Sponsored by
Aysegul Celik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring lung cancer, dyspnea, fan therapy, comfort, oncology nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

hand-held fan airflow stimulation

control group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2023
Last Updated
May 24, 2023
Sponsor
Aysegul Celik
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1. Study Identification

Unique Protocol Identification Number
NCT05887986
Brief Title
Management of Dyspnea: Use of Hand Held Fan
Official Title
Management of Pulmonary Toxicity-related Dyspnea: Effect of Hand-held Fan Airflow Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aysegul Celik

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. The universe of the research was carried out between December 2022 and December 2023, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer, dyspnea, fan therapy, comfort, oncology nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled experimental study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hand-held fan airflow stimulation
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
hand-held fan airflow stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
dyspnea level
Description
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.
Time Frame
baseline, day 3, and day 5
Secondary Outcome Measure Information:
Title
comfort level
Description
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
Time Frame
baseline, day 3, and day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Izmir Provincial Health Directorate Health Sciences University Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital
City
Izmir
Country
Turkey

12. IPD Sharing Statement

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