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.
TERMINATED
PHASE2
22 participants
immediately before exam, immediately after cath placement, and 15min after the 30-minute procedure
2026-06-10
Participant Flow
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
| 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
| 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 procedureParticipants 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
| 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 procedureParticipants 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
| 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
Experimental
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place