NCT05625854

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2021

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

November 25, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

2.1 years

First QC Date

September 14, 2021

Last Update Submit

November 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Patient Health Questionnaire (PHQ-9)

    The score change up to three days.

  • Chinese version of the Edmonton Symptom Assessment System,C-ESAS

    The score change up to three days.

  • Smart bracelet_Heart rate variability (HRV)

    Continue wear bracelet five days to record HRV data.

Study Arms (3)

Blow a fan to the face combine aromatherapy

EXPERIMENTAL
Behavioral: Blow a fan to the face combine aromatherapy

Blow a fan to the face

EXPERIMENTAL
Behavioral: Blow a fan to the face

Blow a fan to the feet

PLACEBO COMPARATOR
Behavioral: Blow a fan to the feet

Interventions

Blow a fan with aromatherapy to the face

Blow a fan to the face combine aromatherapy

Blow a fan to the face

Blow a fan to the face

Blow a fan to the feet

Blow a fan to the feet

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 14, 2021

First Posted

November 23, 2022

Study Start

November 25, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 23, 2022

Record last verified: 2022-11

Locations