Clinical trial NCT06590077: Impact of Aromatherapy on Wellbeing and Relaxation in Gynae Oncology Patients Post Treatment
Official title: A Pilot Study to Investigate the Impact of Aromatherapy on Wellbeing and Relaxation in Gynae Oncology Patients Post Treatment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stress
Wellbeing
Relaxation
Keywords: Aromatherapy
Inhalation
Essential Oil
Complementary Therapy
Stress and anxiety
Relaxation and wellbeing
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: St. James's Hospital, Ireland
First posted: 2024-09-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blind, randomised controlled experiential pilot study with a test and a control product both of which contain essential oil fragrances.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this pilot study is to learn if aromatherapy helps to reduce stress and improve relaxation and wellbeing in gynaecological cancer patients after they have finished their treatment for cancer. The main questions this study aims to answer are:

Is there a benefit in using an aromatherapy product for relaxation and wellbeing after completion of cancer treatment.

Researchers will compare a commercially available aromatherapy test oil blend to a control oil (an oil at high dilution with a faint aroma) to see if the oil blend helps to reduce stress and increase wellbeing and relaxation.

Participants will:

Use a commercially available aromatherapy product or a control every evening for 4 weeks and complete a questionnaire at the start, after 2 weeks and at the end of the 4 week period.

During the four weeks of the study, the participants may wish to record their experience with the test oil and assess its impact on relaxation and wellbeing in a personal diary.

Detailed description: Patients will be identified by Prof Catherine O'Gorman who directs the Gynae-oncology survivorship clinic. Patients who attend the clinic are at least 6 months post treatment for their gynaecological cancer. Patients wo are referred to the clinic undergo a holistic needs assessment as part of their care at the clinic. Following completion of the assessment, Prof O'Gorman will identify patients who would be eligible for the study and supply them with the patient information leaflet and consent form. Those who wish to participate will be contacted by the researcher (Fiona Hedigan) to arrange a meeting in St. James's Hospital.

Patients who have been identified as eligible for the study by Prof O'Gorman will receive a patient information leaflet and consent form at their clinic visit. Those who express an interest in participating in the study will be contacted by the researcher (Fiona Hedigan) who will arrange to meet the patient on site in St. James's Hospital. During the meeting, the study will be explained in detail and the researcher will go through the patient information leaflet and consent form with the patient. If the patient agrees to participate, the consent form will be completed in person with the patient and a copy of the signed consent given to the patient for their records.

Participants will be asked to use an aromatherapy cosmetic product every evening for four weeks and assess its impact on relaxation and wellbeing. The participants will be asked to complete a questionnaire three times: at the start of the study, midway after 2 weeks, and at the end of the 4th week. The test intervention is an aromatherapy cosmetic product containing a blend of 5 essential oils (orange, lavender, frankincense, vetiver, and neroli), diluted in apricot kernel oil. It was formulated by the postgraduate researcher who is a clinical aromatherapist. To date there have been no reports of adverse events. Permission has been given to supply this formula for the research study. The control product will contain a single essential oil (juniper) with a mild aroma at a low concentration diluted in apricot kernel oil.

The Warwick, Edinburgh Mental Wellbeing Scale (WEMWBS) is a validated and effective tool used to measure levels of wellbeing. Initial feedback from using the product will also be obtained by completion of an organoleptic profile survey.

Data from all 3 questionnaires will be pseudonymous, however all the questionnaires responses can be linked via the ID number on the aromatherapy product which participants will insert when completing each survey.

Eligibility criteria: Inclusion Criteria:

* Patients who are 6 months post active treatment attending the gynae oncology clinic at St James's Hospital, Dublin, Ireland.
* Adult with capacity to provide informed consent

Exclusion Criteria:

* Anyone who has a hypersensitive reaction to aromatic fragrances.
* Pregnant or planning a pregnancy

Primary outcomes:
measure: Primary outcome: To measure the effect of an aromatherapy cosmetic product on the levels of relaxation and wellbeing in the participants as determined by questionnaire after four weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Focus Group after completion of the 4 week study
timeFrame: October to December 2024
measure: To measure the effect of an aromatherapy cosmetic product on the levels of relaxation and wellbeing in the participants as determined by questionnaire after two weeks
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. James Hospital, Dublin, Ireland
Study officials:
affiliation: St. James Hospital, Dublin, Ireland
name: Catherine O Gorman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dublin, Trinity College
name: Astrid Sasse
role: PRINCIPAL_INVESTIGATOR
References: