Anxiety Clinical Trial
Official title:
The Use of Lavender Aromatherapy to Decrease Women's Anxiety and Perception of Pain During Office Hysteroscopy Procedure
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | August 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility | - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
Buzzaccarini G, Alonso Pacheco L, Vitagliano A, Haimovich S, Chiantera V, Torok P, Vitale SG, Lagana AS, Carugno J. Pain Management during Office Hysteroscopy: An Evidence-Based Approach. Medicina (Kaunas). 2022 Aug 20;58(8):1132. doi: 10.3390/medicina58081132. — View Citation
Fouks Y, Kern G, Cohen A, Reicher L, Shapira Z, Many A, Yogev Y, Rattan G. A virtual reality system for pain and anxiety management during outpatient hysteroscopy-A randomized control trial. Eur J Pain. 2022 Mar;26(3):600-609. doi: 10.1002/ejp.1882. Epub 2021 Nov 23. — View Citation
Gambadauro P, Navaratnarajah R, Carli V. Anxiety at outpatient hysteroscopy. Gynecol Surg. 2015;12(3):189-196. doi: 10.1007/s10397-015-0895-3. Epub 2015 May 13. — View Citation
Vitale SG, Caruso S, Ciebiera M, Torok P, Tesarik J, Vilos GA, Cholkeri-Singh A, Gulino FA, Kamath MS, Cianci A. Management of anxiety and pain perception in women undergoing office hysteroscopy: a systematic review. Arch Gynecol Obstet. 2020 Apr;301(4):885-894. doi: 10.1007/s00404-020-05460-2. Epub 2020 Mar 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the change in pain scores from baseline to immediate post-procedure. | Participants will then be asked to rate their level of pain immediately before beginning the exam, immediately after catheter placement, and 15 min after termination of the study using the Wong-Baker pain scale. 0 would be no pain at all and 10 would be the worst pain. | 30 minutes | |
Primary | Determine change in anxiety scores from baseline to immediate post-procedure. | Participants will then be asked to rate their level of anxiety immediately before beginning the exam, immediately after catheter placement, and 15 min after termination of the study using a 10-point visual analog scale. 0 corresponds with a pleasant face and represents no anxiety at all and 10 corresponds with a face in distress and represents high levels of anxiety. | 30 minutes | |
Primary | Determine level of satisfaction after the procedure | At the end, the participants will also be asked to rate their satisfaction with the visit overall on a Likert scale. If patient's are satisfied they would choose "Strongly Agree" and if they are dissatisfied with the experience they can choose "Strongly disagree." Agree, disagree and neutral would be the additional choices. | 5 minutes |
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