Trial Outcomes & Findings for Lavender Aromatherapy to Decrease Anxiety/Pain Perception During Office Hysteroscopy (NCT NCT06316934)

NCT ID: NCT06316934

Last Updated: 2026-06-10

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

immediately before exam, immediately after cath placement, and 15min after the 30-minute procedure

Results posted on

2026-06-10

Participant Flow

Participant milestones

Participant milestones
Measure
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 Placebo: 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 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.
Overall Study
STARTED
11
11
Overall Study
COMPLETED
11
10
Overall Study
NOT COMPLETED
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
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 Placebo: 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 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.
Overall Study
Patient was excluded due to recent mental health co-morbidity
0
1

Baseline Characteristics

Lavender Aromatherapy to Decrease Anxiety/Pain Perception During Office Hysteroscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=11 Participants
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 Placebo: Distilled water will be placed on paper towel which patient will deeply inhale prior to the start of the procedure.
Experimental
n=10 Participants
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 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.
Total
n=21 Participants
Total of all reporting groups
Age, Continuous
41 years
n=9 Participants
34.5 years
n=27 Participants
40 years
n=267 Participants
Sex: Female, Male
Female
11 Participants
n=9 Participants
10 Participants
n=27 Participants
21 Participants
n=267 Participants
Sex: Female, Male
Male
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Asian
0 Participants
n=9 Participants
1 Participants
n=27 Participants
1 Participants
n=267 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=9 Participants
2 Participants
n=27 Participants
4 Participants
n=267 Participants
Race (NIH/OMB)
White
8 Participants
n=9 Participants
7 Participants
n=27 Participants
15 Participants
n=267 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=9 Participants
0 Participants
n=27 Participants
1 Participants
n=267 Participants
Region of Enrollment
United States
11 participants
n=9 Participants
10 participants
n=27 Participants
21 participants
n=267 Participants
Baseline anxiety and depression by Hospital Anxiety and Depression scale (HADS)
Anxiety
7 units on a scale
n=9 Participants
5.5 units on a scale
n=27 Participants
6 units on a scale
n=267 Participants
Baseline anxiety and depression by Hospital Anxiety and Depression scale (HADS)
Depression
1 units on a scale
n=9 Participants
1 units on a scale
n=27 Participants
1 units on a scale
n=267 Participants

PRIMARY outcome

Timeframe: immediately before exam, immediately after cath placement, and 15min after the 30-minute 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.

Outcome measures

Outcome measures
Measure
Placebo
n=11 Participants
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 Placebo: Distilled water will be placed on paper towel which patient will deeply inhale prior to the start of the procedure.
Experimental
n=10 Participants
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 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.
Determine the Change in Pain Scores.
Immediately before exam
0 units on a scale
Interval 0.0 to 0.0
0 units on a scale
Interval 0.0 to 0.0
Determine the Change in Pain Scores.
After catheter placement
2 units on a scale
Interval 1.0 to 6.0
5 units on a scale
Interval 3.5 to 6.5
Determine the Change in Pain Scores.
15 min after procedure
0 units on a scale
Interval 0.0 to 2.0
2 units on a scale
Interval 2.0 to 4.0

PRIMARY outcome

Timeframe: immediately before exam, immediately after cath placement, and 15min after the 30-minute 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.

Outcome measures

Outcome measures
Measure
Placebo
n=11 Participants
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 Placebo: Distilled water will be placed on paper towel which patient will deeply inhale prior to the start of the procedure.
Experimental
n=10 Participants
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 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.
Determine Change in Anxiety Scores.
Immediately before exam
2 units on a scale
Interval 0.0 to 4.0
4 units on a scale
Interval 3.0 to 5.0
Determine Change in Anxiety Scores.
after catheter placement
3 units on a scale
Interval 0.0 to 4.0
2 units on a scale
Interval 0.0 to 4.0
Determine Change in Anxiety Scores.
15min after procedure
0 units on a scale
Interval 0.0 to 2.0
0 units on a scale
Interval 0.0 to 2.0

Adverse Events

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Experimental

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tiffani-Amber Miller, MD, MPH

Stony Brook University Hospital

Phone: 631-444-0590

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place