Lavender Aromatherapy to Decrease Anxiety/Pain Perception During Office Hysteroscopy

NCT06316934 | Completed Phase 2 FDA Drug

• 1 other identifier: IRB202302181
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain, Procedural

Keywords

Aromatherapy; Hysteroscopy; Lavender

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Experimental

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

Drug: Lavandula angustifolia, Aura Cacia

Interventions

Lavandula angustifolia, Aura Cacia DRUG

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

Experimental

Placebo OTHER

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

Also known as: Distilled water

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (4)

• 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.

  PMID: 36013599 BACKGROUND

• 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.

  PMID: 34748679 BACKGROUND

• 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.

  PMID: 26283891 BACKGROUND

• 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.

  PMID: 32140807 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain, Procedural

Condition Hierarchy (Ancestors)

Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tiffani-Amber Miller, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: March 19, 2024
• Study Start: June 1, 2024
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)