StressNCT06590077
Impact of Aromatherapy on Wellbeing and Relaxation in Gynae Oncology Patients Post Treatment
A study testing Aromatherapy in people with Stress and Wellbeing, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress, Wellbeing, Relaxation
- What is being tested?
- Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- 19 Aug 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Anyone who has a hypersensitive reaction to aromatic fragrances.
- Pregnant or planning a pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Aromatherapy, Control (placebo) group
- Keywords
- Aromatherapy, Inhalation, Essential Oil, Complementary Therapy, Stress and anxiety, Relaxation and wellbeing
- Medical subject headings
- Respiratory Aspiration, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
Also called Essential Oil, Aromatherapy Inhaler, Aromatherapy blend
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) groupOther
Also called Essential oil - control
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control (placebo) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Aug 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind, randomised controlled experiential pilot study with a test and a control product both of which contain essential oil fragrances.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- St. James's Hospital, Ireland
- Responsible party
- Principal investigator, Astrid Sasse, University of Dublin, Trinity College
- Investigators
- Catherine O Gorman, MD, Principal investigator, St. James Hospital, Dublin, IrelandAstrid Sasse, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590077
- Sponsor's protocol ID
- 4308-24072024
- Status last verified
- Jan 2025
- First submitted
- 6 Sep 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This was not part of our ethics application.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate the Impact of Aromatherapy on Wellbeing and Relaxation in Gynae Oncology Patients Post Treatment
- ClinicalTrials.gov ID
- NCT06590077
- Acronym / sponsor ID
- 4308-24072024
- Conditions
- Stress, Wellbeing, Relaxation
- Keywords
- Aromatherapy, Inhalation, Essential Oil, Complementary Therapy, Stress and anxiety, Relaxation and wellbeing
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- St. James's Hospital, Ireland
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A double-blind, randomised controlled experiential pilot study with a test and a control product both of which contain essential oil fragrances.
| Arm | Type | Receives |
|---|---|---|
| Test blend of five essential oils in a carrier oil - rollerball | Active comparator | Other: AromatherapyThe 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. |
| Control oil - rollerball | Placebo comparator | Other: Control (placebo) groupJuniper essential oil in apricot kernel oil - presentation as a rollerball. The control oil has a mild aroma and is at low concentration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Anyone who has a hypersensitive reaction to aromatic fragrances.
- Pregnant or planning a pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AromatherapyAlso: Essential Oil, Aromatherapy Inhaler, Aromatherapy blendThe 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 | Test blend of five essential oils in a carrier oil - rollerball |
| Control (placebo) groupAlso: Essential oil - controlJuniper 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 | Control oil - rollerball |
Primary outcome
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
Time frame: 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.
2 secondary outcomes
Focus Group after completion of the 4 week study
Time frame: 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
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: No. This was not part of our ethics application.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine O Gorman, MD principal investigator
St. James Hospital, Dublin, Ireland
Astrid Sasse principal investigator
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy in people with Stress and Wellbeing, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.