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

NCT ID: NCT06590077

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-19
• Study Completion Date: 2025-06-30

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.

Conditions

Stress; Wellbeing; Relaxation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Aromatherapy

Intervention Type: OTHER

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.

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.

Group Type: PLACEBO_COMPARATOR

Control (placebo) group

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Essential Oil; Aromatherapy Inhaler; Aromatherapy blend; Essential oil - control

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St. James's Hospital, Ireland

OTHER

Sponsor Role: collaborator

University of Dublin, Trinity College

OTHER

Sponsor Role: lead

Responsible Party

Astrid Sasse

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine O Gorman, MD

Role: PRINCIPAL_INVESTIGATOR

St. James Hospital, Dublin, Ireland

Astrid Sasse

Role: PRINCIPAL_INVESTIGATOR

University of Dublin, Trinity College

Locations

St. James Hospital, Dublin, Ireland

Dublin, Dublin, Ireland

Countries

Ireland

Other Identifiers

4308-24072024

Identifier Type: -

Identifier Source: org_study_id