The Use of Lavender Aromatherapy to Decrease Women's Anxiety and Perception of Pain During Office Hysteroscopy Procedure

IRB202302181

Office hysteroscopy is an invaluable practice to treat a myriad of gynecological processes. However, a limiting factor is the perceived pain and anxiety. In a randomized pilot study, treatment with lavender aromatherapy will significantly decrease the stress/anxiety levels associated with office hysteroscopy, as measured on a visual analogue scale and the Hospital Anxiety and Depression Scale (HADS) questionnaire when compared to control subjects receiving distilled water placebo.

2024-05-01

2024-07-01

2024-08-01

Not yet recruiting

Early phase I

40

* Inclusion Criteria: * Women aged 18 and over * Scheduled to undergo office hysteroscopy procedure * Able to give informed consent * Able to read and write in English * Anxiety score \> 0 on a numerical scale at baseline * Exclusion Criteria: * Any contraindication to office hysteroscopy (active pelvic infection, confirmed cervical or endometrial cancer severe hypertension, or any other condition that might be worsened by an uncomfortable test) * Allergy to lavender oil, or any of its components * Withdrawal Criteria * The patient requests terminating participation

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The participants will be randomized into two arms - aromatherapy or placebo. The protocol will be the same for the two arms except that the towel held over the mouth will be scented either with lavender essential oil or distilled water. The clinic nurse will prepare the scented towel and hand it to the participant according to the random assignment.', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Randomization will be performed once the patient agrees to participate and has signed the consent document. A random number generator will be used to designate each arm of the study. Odd numbers will be assigned to the aromatherapy arm while the even numbers will be assigned to the placebo arm. Each assignment will be placed into a sealed opaque numbered enveloped. After the participant has agreed to participate, the clinic nurse will open the envelope to identify the study arm.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-04-05