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

Not Applicable

• Conditions: Pain; Heart Rate Variability; Anxiety
• Interventions: Other: essential oils

• Registration Number: NCT04826601
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Study Start: 2021-05-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-30
• Last Update Posted: 2021-07-01
• Primary Completion: 2021-12
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	essential oils	-

Primary Outcome Measures

Name	Time	Method
pain score	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

Name	Time	Method
Anxiety	immediately after aromatherapy	State-Trait Anxiety Inventory (STAI)

Trial Locations

Locations (1)

Show Chwan Memorial Hospital; 🇨🇳 Changhua, Taiwan