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

NCT04826601 | Unknown

• 1 other identifier: SRD-109037
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Heart Rate Variability; Anxiety

Outcome Measures

Primary Outcomes (1)

• pain score

  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 Outcomes (1)

• Anxiety

  immediately after aromatherapy

Study Arms (1)

Experimental

EXPERIMENTAL

Other: essential oils

Interventions

essential oils OTHER

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.

Experimental

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Show Chwan Memorial Hospital: lead

Study Sites (1)

Show Chwan Memorial Hospital

Changhua, 500, Taiwan

RECRUITING

Related Publications (5)

• 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.

  PMID: 31779991 BACKGROUND

• 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.

  PMID: 13103829 BACKGROUND

• 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.

  PMID: 13104420 BACKGROUND

• VEILLEUX R. THE STRESS CONCEPT AS WE SEE IT TODAY. Adv Vet Sci. 1963;8:189-213. No abstract available.

  PMID: 14272336 BACKGROUND

• RAJUSZ E. NEUROENDOCRINE RELATIONSHIPS. Prog Neurol Psychiatry. 1963;18:306-47. No abstract available.

  PMID: 14146314 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Oils, Volatile

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Oils; Lipids

Central Study Contacts

Chun-Yi Lin, DrPH

CONTACT

886975611183; amy36372215@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: May 12, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)