Using a Fan With Aromatherapy in Breathlessness Patients in Terminal Illness

Sponsor
Tsai-Wei Huang (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05625854
Collaborator
(none)
99
1
3
25.2
3.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Blow a fan to the face combine aromatherapy
  • Behavioral: Blow a fan to the face
  • Behavioral: Blow a fan to the feet
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
99 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Using a Fan With Aromatherapy in Breathlessness Patient in Terminally Illness: a Randomized Control Trial
Anticipated Study Start Date :
Nov 25, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Chinese version of the Respiratory Distress Observation Scale,C-RDOS [The score change up to three days.]

    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

  1. Patient Health Questionnaire (PHQ-9) [The score change up to three days.]

    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.

  2. Chinese version of the Edmonton Symptom Assessment System,C-ESAS [The score change up to three days.]

    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.

  3. Smart bracelet_Heart rate variability (HRV) [Continue wear bracelet five days to record HRV data.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Medical University Taipei Taiwan 110

Sponsors and Collaborators

  • Tsai-Wei Huang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tsai-Wei Huang, Associate professor, Taipei Medical University
ClinicalTrials.gov Identifier:
NCT05625854
Other Study ID Numbers:
  • fan for dyspnea
First Posted:
Nov 23, 2022
Last Update Posted:
Nov 23, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2022