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Trial Title:
Impact of Aromatherapy on Wellbeing and Relaxation in Gynae Oncology Patients Post Treatment
NCT ID:
NCT06590077
Condition:
Stress
Wellbeing
Relaxation
Conditions: Keywords:
Aromatherapy
Inhalation
Essential Oil
Complementary Therapy
Stress and anxiety
Relaxation and wellbeing
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Other
Intervention name:
Aromatherapy
Description:
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 a clinical aromatherapist. Each participant will be
asked to use the product every evening over 4 weeks and to complete a validated
questionnaire at 3 time points: at the beginning, midway after 2 weeks and at the end of
the 4-week study.
Arm group label:
Test blend of five essential oils in a carrier oil - rollerball
Other name:
Essential Oil
Other name:
Aromatherapy Inhaler
Other name:
Aromatherapy blend
Intervention type:
Other
Intervention name:
Control (placebo) group
Description:
Juniper essential oil in apricot kernel oil in low concentration with a faint aroma -
presentation as a rollerball. Each participant will be asked to use the product every
evening over 4 weeks and to complete a validated questionnaire at 3 time points: at the
beginning, midway after 2 weeks and at the end of the 4-week study.
Arm group label:
Control oil - rollerball
Other name:
Essential oil - control
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St. James Hospital, Dublin, Ireland
Address:
City:
Dublin
Country:
Ireland
Start date:
August 19, 2024
Completion date:
December 2024
Lead sponsor:
Agency:
University of Dublin, Trinity College
Agency class:
Other
Collaborator:
Agency:
St. James's Hospital, Ireland
Agency class:
Other
Source:
University of Dublin, Trinity College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06590077
