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

NCT06590077 | Enrolling By Invitation

• 1 other identifier: 4308-24072024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Wellbeing; Relaxation

Keywords

Aromatherapy; Inhalation; Essential Oil; Complementary Therapy; Stress and anxiety; Relaxation and wellbeing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Focus Group after completion of the 4 week study

  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

  2 weeks

Study Arms (2)

Test blend of five essential oils in a carrier oil - rollerball

ACTIVE COMPARATOR

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

Control oil - rollerball

PLACEBO COMPARATOR

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

Interventions

Aromatherapy 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.

Also known as: Essential Oil, Aromatherapy Inhaler, Aromatherapy blend

Test blend of five essential oils in a carrier oil - rollerball

Control (placebo) group 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.

Also known as: Essential oil - control

Control oil - rollerball

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• St. James's Hospital, Ireland: collaborator

Study Sites (1)

St. James Hospital, Dublin, Ireland

Dublin, Dublin, Ireland

Location

MeSH Terms

Conditions

Respiratory Aspiration; Anxiety Disorders

Interventions

Aromatherapy; Oils, Volatile; Population Groups

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities; Oils; Lipids; Demography; Population Characteristics

Study Officials

• Catherine O Gorman, MD

  St. James Hospital, Dublin, Ireland

  PRINCIPAL INVESTIGATOR

• Astrid Sasse

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A double-blind, randomised controlled experiential pilot study with a test and a control product both of which contain essential oil fragrances.

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: August 19, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)