Trial Outcomes & Findings for Lavender Aromatherapy for Anxiety During Urodynamics (NCT NCT02344745)
NCT ID: NCT02344745
Last Updated: 2016-12-16
Results Overview
Anxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Higher values indicate more anxiety.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
At the time of catheter placement
Results posted on
2016-12-16
Participant Flow
Participant milestones
| Measure |
Control
Distilled water
Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
|
Lavender
Lavandula angustifolia essential oil (Aura Cacia)
Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
38
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Control
Distilled water
Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
|
Lavender
Lavandula angustifolia essential oil (Aura Cacia)
Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
|
|---|---|---|
|
Overall Study
Data collection sheets were lost
|
2
|
0
|
Baseline Characteristics
Lavender Aromatherapy for Anxiety During Urodynamics
Baseline characteristics by cohort
| Measure |
Control
n=38 Participants
Distilled water
Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
|
Lavender
n=40 Participants
Lavandula angustifolia essential oil (Aura Cacia)
Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
49.0 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
48.5 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Gender
Female
|
38 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Anxiety
|
4 cm
n=5 Participants
|
5 cm
n=7 Participants
|
5 cm
n=5 Participants
|
|
Pain
|
0 units on a scale
n=5 Participants
|
0 units on a scale
n=7 Participants
|
0 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: At the time of catheter placementAnxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Higher values indicate more anxiety.
Outcome measures
| Measure |
Control
n=38 Participants
Distilled water
Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
|
Lavender
n=40 Participants
Lavandula angustifolia essential oil (Aura Cacia)
Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
|
|---|---|---|
|
Anxiety Measured by VAS
|
4 cm
Interval 0.0 to 9.0
|
3 cm
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: At the time of catheter placementPain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.
Outcome measures
| Measure |
Control
n=38 Participants
Distilled water
Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
|
Lavender
n=40 Participants
Lavandula angustifolia essential oil (Aura Cacia)
Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
|
|---|---|---|
|
Wong Baker Pain Scale
|
0 units on a scale
Interval 0.0 to 5.0
|
0 units on a scale
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: 15 min after removal of the urodynamics cathetersAnxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Higher values indicate more anxiety.
Outcome measures
| Measure |
Control
n=38 Participants
Distilled water
Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
|
Lavender
n=39 Participants
Lavandula angustifolia essential oil (Aura Cacia)
Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
|
|---|---|---|
|
Anxiety Measured by VAS
|
0.5 cm
Interval 0.0 to 5.0
|
0 cm
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 15 min after removal of the urodynamics cathetersPain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.
Outcome measures
| Measure |
Control
n=38 Participants
Distilled water
Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
|
Lavender
n=39 Participants
Lavandula angustifolia essential oil (Aura Cacia)
Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
|
|---|---|---|
|
Wong Baker Pain Scale
|
0 units on a scale
Interval 0.0 to 5.0
|
0 units on a scale
Interval 0.0 to 2.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lavender
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place