Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06590077
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Impact of Aromatherapy on Wellbeing and Relaxation in Gynae Oncology Patients Post Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study to Investigate the Impact of Aromatherapy on Wellbeing and Relaxation in Gynae Oncology Patients Post Treatment
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 OGorman 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 OGorman 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 Jamess Hospital
Patients who have been identified as eligible for the study by Prof OGorman 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 Jamess 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
Patients who have been identified as eligible for the study by Prof OGorman 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 Jamess 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None