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Enrolling by invitation Not applicable

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

NCT06590077 · tracked via the Priya Life Science Ireland tracker
Phase
Not applicable
Started
2024-08-19
Last updated
2025-01-09

Condition(s) studied

StressWellbeingRelaxation

Investigational drug(s) / intervention(s)

AromatherapyControl (placebo) group

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.

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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 — 4 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.

Trial sites (1)

FacilityCityRegionStatus
St. James Hospital, Dublin, Ireland Dublin Dublin
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06590077 on ClinicalTrials.gov ↗ ← All trials in Ireland