Using a Fan With Aromatherapy in Breathlessness Patients in Terminal Illness

The Effect of Using a Fan With Aromatherapy in Breathlessness Patient in Terminally Illness: a Randomized Control Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Terminal Illness; Aromatherapy; Breathlessness; Fans
• Intervention / Treatment: Behavioral: Blow a fan to the face combine aromatherapy; Behavioral: Blow a fan to the face; Behavioral: Blow a fan to the feet

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

1. Over 20 years old.
2. It is determined by the physician to meet the final diagnosis conditions.
3. Symptoms of dyspnea.
4. 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.
5. Able to communicate in Mandarin or Taiwanese or written conversation.
6. Unconscious disorder.
7. After explaining and explaining, agree to participate in this research and sign the consent form.

Exclusion criteria

1. Receive treatment for facial trigeminal nerve damage.
2. Abnormal sense of smell.

• Study Type: Interventional
• Enrollment (Anticipated): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Over 20 years old.
2. It is determined by the physician to meet the final diagnosis conditions.
3. Symptoms of dyspnea.
4. The status of patients is assessed using the East Coast Cancer Clinical Research Cooperative Organization Assessment Scale (ECOG) ≧ 2 points.
5. Able to communicate in Mandarin or Taiwanese or written conversation.
6. Conscience clear.
7. After explaining and explaining, agree to participate in this research and sign the consent form.

Exclusion Criteria:

1. Receive treatment for facial trigeminal nerve damage.
2. Abnormal sense of smell.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blow a fan to the face combine aromatherapy	Behavioral: Blow a fan to the face combine aromatherapy; Blow a fan with aromatherapy to the face
Experimental: Blow a fan to the face	Behavioral: Blow a fan to the face; Blow a fan to the face
Placebo Comparator: Blow a fan to the feet	Behavioral: Blow a fan to the feet; Blow a fan to the feet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The score change up to three days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The score change up to three days.
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.	The score change up to three days.
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.	Continue wear bracelet five days to record HRV data.

Collaborators and Investigators

• Sponsor: Tsai-Wei Huang

Study record dates

Study Major Dates

• Study Start (Anticipated): November 25, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Anesthetics, Local; Dopamine Uptake Inhibitors; Vasoconstrictor Agents; Cocaine
• Other Study ID Numbers: fan for dyspnea

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No