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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04826601
• Other study ID #: SRD-109037
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: March 2022

Study information

• Verified date: June 2021
• Source: Show Chwan Memorial Hospital
• Contact: Chun-Yi Lin, DrPH
• Phone: 886975611183
• Email: amy36372215[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Heart Rate Variability
• Pain

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Show Chwan Memorial Hospital	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Show Chwan Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & 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. — View 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. — View 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. — View Citation

RAJUSZ E. NEUROENDOCRINE RELATIONSHIPS. Prog Neurol Psychiatry. 1963;18:306-47. Review. — View Citation

VEILLEUX R. THE STRESS CONCEPT AS WE SEE IT TODAY. Adv Vet Sci. 1963;8:189-213. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anxiety	State-Trait Anxiety Inventory (STAI)	immediately after aromatherapy