Clinical trial NCT04826601: The Physical and Psychologic Effects of Aromatherapy in Cancer Patients During Chemotherapy
Official title: The Physical and Psychologic Effects of Aromatherapy in Cancer Patients During Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Heart Rate Variability
Anxiety
Lead sponsor: Show Chwan Memorial Hospital
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: pain score
timeFrame: immediately after aromatherapy
Secondary outcomes:
measure: Anxiety
timeFrame: immediately after aromatherapy
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Show Chwan Memorial Hospital
Study officials:
References:
citation: Farahani MA, Afsargharehbagh R, Marandi F, Moradi M, Hashemi SM, Moghadam MP, Balouchi A. Effect of aromatherapy on cancer complications: A systematic review. Complement Ther Med. 2019 Dec;47:102169. doi: 10.1016/j.ctim.2019.08.003. Epub 2019 Aug 5.
citation: POKORNY AD, MOORE FJ. Neuroses and compensation: chronic psychiatric disorders following injury or stress in compensable situations. I. Review of the literature. AMA Arch Ind Hyg Occup Med. 1953 Dec;8(6):547-63. No abstract available.
citation: MIKUTA JJ, PAYNE FL. Stress urinary incontinence in the female; a review of the modern approach to this problem. Am J Med Sci. 1953 Dec;226(6):674-87. doi: 10.1097/00000441-195312000-00010. No abstract available.
citation: VEILLEUX R. THE STRESS CONCEPT AS WE SEE IT TODAY. Adv Vet Sci. 1963;8:189-213. No abstract available.
citation: RAJUSZ E. NEUROENDOCRINE RELATIONSHIPS. Prog Neurol Psychiatry. 1963;18:306-47. No abstract available.