Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 6:09 AM
Study NCT ID:
NCT06316934
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2024-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lavender Aromatherapy to Decrease Anxiety/Pain Perception During Office Hysteroscopy
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
The Use of Lavender Aromatherapy to Decrease Women's Anxiety and Perception of Pain During Office Hysteroscopy Procedure
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
This study is a randomized placebo control trial. The designation of aromatherapy versus placebo will be randomized, but no procedures will be performed for study purposes that would not be normally performed for a patient's clinical assessment.
Women scheduled for Office Hysteroscopy at the Women's Health Medical Plaza Clinic (UF Shands) clinic will be invited to participate. Participants who meet inclusion criteria will be randomized to the aromatherapy or the placebo group after informed consent is obtained and immediately before undergoing the Hysteroscopy procedure. Sequentially numbered sealed opaque envelopes containing the identity of the study arm will be used for randomization. The Medical Plaza clinic nurse will prepare the aromatherapy versus distilled water on the paper towel with two drops of each utilized. Before the physician comes in, the nurse will ask the participant to take a deep breath while holding the towel 3 inches from her face and will instruct the participant to continue to take normal breaths subsequently. It will not be possible to blind the participants or the examiner to the assigned group since the lavender oil will have a different scent than the placebo. However, the use of distilled water on the towel will allow the possibility that the deep breathing accompanying the instruction may have an effect on reported pain and anxiety.
Vaginoscopy approach will be utilized to perform the procedure. This avoids the use of a speculum in the vagina or tenaculum to grasp the cervix. This is a atraumatic technique that reduces pain stimuli generated from the cervix and the vagina when using manipulating instruments. Vaginoscopy relies on hydrodilation of the cervical canal for entry of a small-caliber scope. This technique involves distending the vaginal vault with normal saline and advancing the scope to the posterior fornix. Gently pulling back until the external cervical os is visualized and then the scope is advanced into the cervical canal.
The participant will undergo the standard clinic exam in a standardized order. The participants will complete the Hospital Anxiety and Depression Survey (HADS) at baseline. The HADS (Appendix II) is a reliable instrument for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic; it is available in English and Spanish versions. This will be used to establish their baseline anxiety levels. Participants will then be asked to rate their level of anxiety and pain immediately before beginning the exam, immediately after hysteroscope placement, and 15 min after termination of the study using a 10-point visual analogue scale and the Wong-Baker pain scale. At the end, the participants will also be asked to rate their satisfaction with the visit overall on a visual analogue scale.
Women scheduled for Office Hysteroscopy at the Women's Health Medical Plaza Clinic (UF Shands) clinic will be invited to participate. Participants who meet inclusion criteria will be randomized to the aromatherapy or the placebo group after informed consent is obtained and immediately before undergoing the Hysteroscopy procedure. Sequentially numbered sealed opaque envelopes containing the identity of the study arm will be used for randomization. The Medical Plaza clinic nurse will prepare the aromatherapy versus distilled water on the paper towel with two drops of each utilized. Before the physician comes in, the nurse will ask the participant to take a deep breath while holding the towel 3 inches from her face and will instruct the participant to continue to take normal breaths subsequently. It will not be possible to blind the participants or the examiner to the assigned group since the lavender oil will have a different scent than the placebo. However, the use of distilled water on the towel will allow the possibility that the deep breathing accompanying the instruction may have an effect on reported pain and anxiety.
Vaginoscopy approach will be utilized to perform the procedure. This avoids the use of a speculum in the vagina or tenaculum to grasp the cervix. This is a atraumatic technique that reduces pain stimuli generated from the cervix and the vagina when using manipulating instruments. Vaginoscopy relies on hydrodilation of the cervical canal for entry of a small-caliber scope. This technique involves distending the vaginal vault with normal saline and advancing the scope to the posterior fornix. Gently pulling back until the external cervical os is visualized and then the scope is advanced into the cervical canal.
The participant will undergo the standard clinic exam in a standardized order. The participants will complete the Hospital Anxiety and Depression Survey (HADS) at baseline. The HADS (Appendix II) is a reliable instrument for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic; it is available in English and Spanish versions. This will be used to establish their baseline anxiety levels. Participants will then be asked to rate their level of anxiety and pain immediately before beginning the exam, immediately after hysteroscope placement, and 15 min after termination of the study using a 10-point visual analogue scale and the Wong-Baker pain scale. At the end, the participants will also be asked to rate their satisfaction with the visit overall on a visual analogue scale.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: