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Using a Fan With Aromatherapy in Breathlessness Patients in Terminal Illness

Primary Purpose

Breathlessness, Aromatherapy, Fans

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Blow a fan to the face combine aromatherapy
Blow a fan to the face
Blow a fan to the feet
Sponsored by
Tsai-Wei Huang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breathlessness

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Over 20 years old. It is determined by the physician to meet the final diagnosis conditions. Symptoms of dyspnea. The status of patients is assessed using the East Coast Cancer Clinical Research Cooperative Organization Assessment Scale (ECOG) ≧ 2 points. Able to communicate in Mandarin or Taiwanese or written conversation. Conscience clear. After explaining and explaining, agree to participate in this research and sign the consent form. Exclusion Criteria: Receive treatment for facial trigeminal nerve damage. Abnormal sense of smell.

Sites / Locations

  • Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Blow a fan to the face combine aromatherapy

Blow a fan to the face

Blow a fan to the feet

Arm Description

Outcomes

Primary Outcome Measures

Chinese version of the Respiratory Distress Observation Scale,C-RDOS
RDOS is an eight-item ordinal scale designed to measure the presence and intensity of respiratory distress in adults. High score means high respiratory distress.

Secondary Outcome Measures

Patient Health Questionnaire (PHQ-9)
The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care.[2] It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment. high score mean higher emotion distress.
Chinese version of the Edmonton Symptom Assessment System,C-ESAS
The ESAS includes 11 symptoms: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and other. It uses a 0-10 numerical scale: 0 shows the absence of a symptom, and 10 shows the worst experience of the symptom.
Smart bracelet_Heart rate variability (HRV)
HRV is the physiological phenomenon of the variation in the time interval between consecutive heartbeats in milliseconds. A normal, healthy heart does not tick evenly like a metronome, but instead, when looking at the milliseconds between heartbeats, there is constant variation.

Full Information

First Posted
September 14, 2021
Last Updated
November 22, 2022
Sponsor
Tsai-Wei Huang
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1. Study Identification

Unique Protocol Identification Number
NCT05625854
Brief Title
Using a Fan With Aromatherapy in Breathlessness Patients in Terminal Illness
Official Title
The Effect of Using a Fan With Aromatherapy in Breathlessness Patient in Terminally Illness: a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 25, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tsai-Wei Huang

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
Difficulty breathing is a very devastating symptom, often seen in terminal patients. Accompanied by physical, psychological, emotional, and social limitations, Not to mention the ambiguity in the occurrence of dyspnea symptoms and the difficulty in obtaining satisfactory quality of symptom care. The purpose of this study is to confirm the use of non-drug interventions in clinical situations, such as fans and aromatherapy to alleviate the complications of end-stage patients. The effectiveness of the symptoms of dyspnea.
Detailed Description
Difficulty breathing is a very devastating symptom, often seen in terminal patients. Accompanied by physical, psychological, emotional, and social limitations, Not to mention the ambiguity in the occurrence of dyspnea symptoms and the difficulty in obtaining satisfactory quality of symptom care. The purpose of this study is to confirm the use of non-drug interventions in clinical situations, such as fans and aromatherapy to alleviate the complications of end-stage patients. The effectiveness of the symptoms of dyspnea. Inclusion criteria Over 20 years old. It is determined by the physician to meet the final diagnosis conditions. Symptoms of dyspnea. The daily physical status of patients is assessed using the East Coast Cancer Clinical Research Cooperative Organization Assessment Scale (Eastern Cooperative Oncology Group, ECOG) ≧ 2 points. Able to communicate in Mandarin or Taiwanese or written conversation. Unconscious disorder. After explaining and explaining, agree to participate in this research and sign the consent form. Exclusion criteria Receive treatment for facial trigeminal nerve damage. Abnormal sense of smell.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breathlessness, Aromatherapy, Fans, Terminal Illness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blow a fan to the face combine aromatherapy
Arm Type
Experimental
Arm Title
Blow a fan to the face
Arm Type
Experimental
Arm Title
Blow a fan to the feet
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Blow a fan to the face combine aromatherapy
Intervention Description
Blow a fan with aromatherapy to the face
Intervention Type
Behavioral
Intervention Name(s)
Blow a fan to the face
Intervention Description
Blow a fan to the face
Intervention Type
Behavioral
Intervention Name(s)
Blow a fan to the feet
Intervention Description
Blow a fan to the feet
Primary Outcome Measure Information:
Title
Chinese version of the Respiratory Distress Observation Scale,C-RDOS
Description
RDOS is an eight-item ordinal scale designed to measure the presence and intensity of respiratory distress in adults. High score means high respiratory distress.
Time Frame
The score change up to three days.
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
The PHQ-9 is the depression module, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care.[2] It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment. high score mean higher emotion distress.
Time Frame
The score change up to three days.
Title
Chinese version of the Edmonton Symptom Assessment System,C-ESAS
Description
The ESAS includes 11 symptoms: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and other. It uses a 0-10 numerical scale: 0 shows the absence of a symptom, and 10 shows the worst experience of the symptom.
Time Frame
The score change up to three days.
Title
Smart bracelet_Heart rate variability (HRV)
Description
HRV is the physiological phenomenon of the variation in the time interval between consecutive heartbeats in milliseconds. A normal, healthy heart does not tick evenly like a metronome, but instead, when looking at the milliseconds between heartbeats, there is constant variation.
Time Frame
Continue wear bracelet five days to record HRV data.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 20 years old. It is determined by the physician to meet the final diagnosis conditions. Symptoms of dyspnea. The status of patients is assessed using the East Coast Cancer Clinical Research Cooperative Organization Assessment Scale (ECOG) ≧ 2 points. Able to communicate in Mandarin or Taiwanese or written conversation. Conscience clear. After explaining and explaining, agree to participate in this research and sign the consent form. Exclusion Criteria: Receive treatment for facial trigeminal nerve damage. Abnormal sense of smell.
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan

12. IPD Sharing Statement

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Using a Fan With Aromatherapy in Breathlessness Patients in Terminal Illness

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