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The Physical and Psychologic Effects of Aromatherapy in Cancer Patients During Chemotherapy

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ClinicalTrials.gov Identifier: NCT04826601
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : July 1, 2021
Sponsor:
Information provided by (Responsible Party):
Chun-Yi Lin, Show Chwan Memorial Hospital

Brief Summary:

Background: Stress is the critical method for survive of reacting to a condition including a threat, challenge or physical and psychological challenge. Stress either physiological or biological is an organism's response to a stressor such as an environmental condition. Stimuli that alter an organism's environment are responded to by multiple systems in the body. The hypothalamic-pituitary-adrenal (HPA) axis and autonomic nervous system are major systems which the body reacts to the stress. It has been reported that cancer patients receiving chemotherapy perceived a lot of stress. It has been believed and well known that stress-related illness is one of the reasons contributing to the increase in long-term sick leave during the last decade in many countries.

Purpose: The aims of this study are to evaluate the effects of aromatherapy on cancer patient receiving chemotherapy: 1) for physical effects by meridian electrical conductance, heart rate variability (HRV), vital sign, visual analogue scale (VAS) for pain; 2) for psychologic effects by State-Trait Anxiety Inventory (STAI).

Materials and methods: This is a prospective, pre post comparison study. A total of 40 cancer patients receiving chemotherapy will be recruited as participants in this study. The characteristics data will be collected in all participants. Blood orange and rosewood will be chosen as the essential oils for aromatherapy in this study. Essential oils will be applied to all participants by inhalation for 30 minutes. Meridian electrical conductance, HRV, vital sign, VAS for pain, and STAI were evaluated and compared before and after aromatherapy.

Expected outcomes: It is expected to understand more about the effects of aromatherapy on the meridian system, HRV and emotional status by undertaking 30 minutes session aromatherapy intervention for cancer patients receiving chemotherapy. The results may suggest aromatherapy as one of the affiliated programs of chemotherapy.


Condition or disease Intervention/treatment Phase
Pain Heart Rate Variability Anxiety Other: essential oils Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Physical and Psychologic Effects of Aromatherapy in Cancer Patients During Chemotherapy
Actual Study Start Date : May 12, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Experimental Other: essential oils
A total of 40 cancer patients receiving chemotherapy will be recruited as participants in this study. Blood orange and rosewood will be chosen as the essential oils for aromatherapy in this study. Essential oils will be applied to all participants by inhalation for 30 minutes.




Primary Outcome Measures :
  1. pain score [ Time Frame: immediately after aromatherapy ]
    Visual analogue scale for pain. Scores are recorded between 0 for "no pain" and 10 for "worst pain". A higher score indicates greater pain intensity.


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: immediately after aromatherapy ]
    State-Trait Anxiety Inventory (STAI)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cancer patients in chemotherapy
  • Subjects who are aged from 20 to 70 years-old

Exclusion Criteria:

  • Subjects who are unable to read and sign the consent form
  • diagnosed with a major illness (such as acute myocardial infarction, stroke, paralysis, and major organ transplantation)
  • being pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04826601


Contacts
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Contact: Chun-Yi Lin, DrPH 886975611183 amy36372215@gmail.com

Locations
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Taiwan
Show Chwan Memorial Hospital Recruiting
Changhua, Taiwan, 500
Contact: Chun-Yi Lin, DrPH    886975611183    amy36372215@gmail.com   
Sponsors and Collaborators
Show Chwan Memorial Hospital
Publications:
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Responsible Party: Chun-Yi Lin, Dr., Show Chwan Memorial Hospital
ClinicalTrials.gov Identifier: NCT04826601    
Other Study ID Numbers: SRD-109037
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: July 1, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No