Management of Dyspnea: Use of Hand Held Fan

NCT05887986 | Completed

• 1 other identifier: BU
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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 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

Keywords

lung cancer; dyspnea; fan therapy; comfort; oncology nursing

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, day 3, and day 5

Secondary Outcomes (1)

• comfort level

  baseline, day 3, and day 5

Study Arms (2)

hand-held fan airflow stimulation

EXPERIMENTAL

Other: hand-held fan airflow stimulation

control group

NO INTERVENTION

Interventions

hand-held fan airflow stimulation OTHER

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.

hand-held fan airflow stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aysegul Celik: lead

Study Sites (1)

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

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms; Dyspnea

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ass. Prof

Model Details: Randomized controlled experimental study

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: June 5, 2023
• Study Start: December 22, 2022
• Primary Completion: February 9, 2024
• Study Completion: February 15, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

TU (1)