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

June 30, 2021 updated by: Chun-Yi Lin, Show Chwan Memorial Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Changhua, Taiwan, 500
        • Recruiting
        • Show Chwan Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
immediately after aromatherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: immediately after aromatherapy
State-Trait Anxiety Inventory (STAI)
immediately after aromatherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Show Chwan Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • SRD-109037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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