Impact of Aromatherapy on Wellbeing and Relaxation in Gynae Oncology Patients Post Treatment

A Pilot Study to Investigate the Impact of Aromatherapy on Wellbeing and Relaxation in Gynae Oncology Patients Post Treatment

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Wellbeing; Stress; Relaxation
• Intervention / Treatment: Other: Aromatherapy; Other: Control (placebo) group

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • St. James Hospital, Dublin, Ireland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test blend of five essential oils in a carrier oil - rollerball; The test product contains a blend of 5 essential oils (orange, lavender, frankincense, vetiver, and neroli), diluted in apricot kernel oil. It was formulated by a clinical aromatherapist (Fiona Hedigan) to promote wellbeing and aid relaxation. To date there have been no reports of adverse events. Permission has been given to supply this formula for the research study. The rollerball product ('REST') is available commercially under the FLORA & FIONA brand.	Other: Aromatherapy; 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.; Other Names: Essential Oil; Aromatherapy Inhaler; Aromatherapy blend
Placebo Comparator: Control oil - rollerball; Juniper essential oil in apricot kernel oil - presentation as a rollerball. The control oil has a mild aroma and is at low concentration.	Other: Control (placebo) group; 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.; Other Names: Essential oil - control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Each participant will complete a validated questionnaire at 3 time points: at the beginning, midway after 2 weeks and at the end of the 4-week study. The Warwick, Edinburgh Mental Wellbeing Scale (WEMWBS) is a validated and effective tool used to measure levels of wellbeing. Wellbeing scores range from 14 (poor wellbeing) to 70 where 70 is 'high wellbeing'. Data from all 3 questionnaires can be linked via the ID number on the aromatherapy product which participants will insert when completing each survey. The primary outcome measure will compare the questionnaire at the beginning of the study with the questionnaire at the end of the four week period.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Focus Group after completion of the 4 week study	Conduct in-person focus groups on site in the hospital to gain further feedback of using the aromatherapy rollerball product.	October to December 2024
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	Each participant will complete a validated questionnaire at 3 time points: at the beginning, midway after 2 weeks and at the end of the 4-week study. The Warwick, Edinburgh Mental Wellbeing Scale (WEMWBS) is a validated and effective tool used to measure levels of wellbeing. Wellbeing scores range from 14 (poor wellbeing) to 70 where 70 is 'high wellbeing'. Data from all 3 questionnaires can be linked via the ID number on the aromatherapy product which participants will insert when completing each survey. The secondary outcome measure will compare the questionnaire at the beginning of the study with the questionnaire at the end of the two week period.	2 weeks

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Collaborators: St. James's Hospital, Ireland
• Investigators: Principal Investigator: Catherine O Gorman, MD, St. James Hospital, Dublin, Ireland; Principal Investigator: Astrid Sasse, University of Dublin, Trinity College

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 6, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Inhalation; Aromatherapy; Complementary Therapy; Essential Oil; Stress and anxiety; Relaxation and wellbeing
• Other Study ID Numbers: 4308-24072024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This was not part of our ethics application.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No