protocolSection identificationModule nctId: NCT06316934, orgStudyIdInfo id: IRB202302181, briefTitle: Lavender Aromatherapy to Decrease Anxiety/Pain Perception During Office Hysteroscopy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Florida, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Anxiety, conditions: Pain, Procedural, designModule 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, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Lavandula angustifolia, Aura Cacia, interventions name: Placebo, outcomesModule primaryOutcomes measure: Determine the change in pain scores from baseline to immediate post-procedure., primaryOutcomes measure: Determine change in anxiety scores from baseline to immediate post-procedure., primaryOutcomes measure: Determine level of satisfaction after the procedure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Florida, city: Gainesville, state: Florida, zip: 32610, country: United States, contacts name: Tiffani-Amber Miller, MD, role: CONTACT, phone: 352-273-7660, email: tiffani12@ufl.edu, contacts name: Amira Quevedo, MD, role: CONTACT, phone: 352-273-7660, email: amiraquevedo@ufl.edu, geoPoint lat: 29.65163, lon: -82.32483, hasResults: False