- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04826601
The Physical and Psychologic Effects of Aromatherapy in Cancer Patients During Chemotherapy
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Chun-Yi Lin, DrPH
- Telefonnummer: 886975611183
- E-mail: amy36372215@gmail.com
Studiesteder
-
-
-
Changhua, Taiwan, 500
- Rekruttering
- Show Chwan Memorial Hospital
-
Kontakt:
- Chun-Yi Lin, DrPH
- Telefonnummer: 886975611183
- E-mail: amy36372215@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Eksperimentel
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
pain score
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Anxiety
Tidsramme: immediately after aromatherapy
|
State-Trait Anxiety Inventory (STAI)
|
immediately after aromatherapy
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- VEILLEUX R. THE STRESS CONCEPT AS WE SEE IT TODAY. Adv Vet Sci. 1963;8:189-213. No abstract available.
- RAJUSZ E. NEUROENDOCRINE RELATIONSHIPS. Prog Neurol Psychiatry. 1963;18:306-47. No abstract available.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- SRD-109037
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Smerte
-
Istanbul University - CerrahpasaRekrutteringPatellofemoral Pain, PfpTyrkiet (Türkiye)
-
Pamukkale UniversityIkke rekrutterer endnuPatellofemoral Pain, PfpTyrkiet (Türkiye)
-
Beijing Sport UniversityAfsluttetPatellofemoral Pain, PfpKina
-
Beijing Sport UniversityIkke rekrutterer endnuPatellofemoral Pain, Pfp
-
Beijing Sport UniversityIkke rekrutterer endnu
-
Sahmyook UniversityAfsluttetMyofascial Pain Syndrome (MPS)Sydkorea
-
Future University in EgyptAfsluttet
-
Camilo Jose Cela UniversityAfsluttetMyofascial Pain Syndrome (MPS)Spanien
-
Izmir Tinaztepe UniversityEge UniversityIkke rekrutterer endnuRygliggende stilling | FLACC Skala | Behavioral Pain Scale
-
University of California, DavisNational Institutes of Health (NIH); National Center for Complementary...Ikke rekrutterer endnuKronisk lænderygsmerter (cLBP) | Myofascial Pain Syndrome (MPS)Forenede Stater
Kliniske forsøg med essential oils
-
China Medical University HospitalRekrutteringMild kognitiv svækkelseTaiwan
-
Inonu UniversityAfsluttetUniversitetsstuderendeKalkun
-
Jaseng Hospital of Korean MedicineAfsluttetSunde frivilligeKorea, Republikken
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbejdspartnereTilmelding efter invitation
-
University of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RekrutteringNAFLD | Teenagers fedme | Hepatisk SteatoseForenede Stater
-
University of Colorado, DenverAfsluttetFedme | Polycystisk ovariesyndrom | Hepatisk SteatoseForenede Stater
-
Fundación EPICRekrutteringKoronararteriesygdom | Iskæmisk hjertesygdomHong Kong
-
Supplement Formulators, Inc.AfsluttetBetændelseForenede Stater
-
Supplement Formulators, Inc.AfsluttetBetændelse | Inflammatorisk responsForenede Stater
-
Weill Medical College of Cornell UniversityAmerican Heart AssociationRekrutteringKardiovaskulær | Kardiovaskulær sundhed | Kardiovaskulær (CV) risiko | Risikofaktorer for hjertekarsygdomme (CVD).Forenede Stater