Lavender Aromatherapy to Decrease Anxiety/Pain Perception During Office Hysteroscopy

NCT ID: NCT06316934

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-04-21

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.

Conditions

Anxiety; Pain, Procedural

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Prior to starting the procedure, the clinic nurse will prepare the distilled water on a paper towel by applying two drops of each solution on a paper towel. The patients will hold the paper towel over their nose and then they will be asked to take two deep breaths. 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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Distilled water will be placed on paper towel which patient will deeply inhale prior to the start of the procedure.

Experimental

Prior to starting the procedure, the clinic nurse will prepare the aromatherapy Lavender essential oil on a paper towel by applying two drops of each solution on a paper towel. The patients will hold the paper towel over their nose and then they will be asked to take two deep breaths. 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

Group Type: EXPERIMENTAL

Lavandula angustifolia, Aura Cacia

Intervention Type: DRUG

Lavender essential oil will be placed on paper towel which patient will deeply inhale prior to the start of the procedure.

Interventions

Lavandula angustifolia, Aura Cacia

Lavender essential oil will be placed on paper towel which patient will deeply inhale prior to the start of the procedure.

Intervention Type: DRUG

Placebo

Distilled water will be placed on paper towel which patient will deeply inhale prior to the start of the procedure.

Intervention Type: OTHER

Other Intervention Names

Distilled water

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiffani-Amber Miller, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 36013599 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34748679 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26283891 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32140807 (View on PubMed)

Other Identifiers

IRB202302181

Identifier Type: -

Identifier Source: org_study_id