- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05540418
Effect of Lavender Oil Inhalation in Colonoscopy Patients
The Effect of Lavender Oil Inhalation on Anxiety and Comfort in Patients Undergoing Colonoscopy: A Randomized Controlled, Single-center Study.
Aim: In this study, it was aimed to determine the effect of lavender oil inhalation on the anxiety and comfort levels of patients who will undergo colonoscopy.
Material and Method: In this randomized controlled, prospective study, 73 experimental and 72 control group patients who will experience colonoscopy in a training and research hospital in western Turkey were included. While lavender inhalation was applied to the patients in the experimental group, routine care was applied to the patients in the control group. The short-form state-trait anxiety scale and general comfort scale were used to collect data before and after the procedure. p<0.05 level was considered statistically significant.
Study Overview
Detailed Description
Colonoscopy is a painful and uncomfortable procedure, and patients experience anxiety and restlessness / tension before colonoscopy. It is stated that aromatherapy, which is a non-invasive method and easy to apply, can be used to reduce these negative effects.
It is known that the fastest and easiest way of entry of essential oils into the body is inhalation. In addition, it is stated that it is safe to carry out these applications by inhalation; For this reason, studies are mostly carried out by inhalation of essential oils. In studies conducted in different fields, it is seen that lavender has positive effects on variables such as anxiety, pain, insomnia, comfort and vital signs. Looking at the literature; more music therapy and education are applied to patients who will experience anxiety and loss of comfort due to colonoscopy; As for aromatherapy interventions; In a study conducted in 2017 with Sunflower and Neroli (Orange Flower) oil, olive flower oil (Osmanthus fragrans) and grapefruit oil were used.
In this study, it was aimed to determine the effect of lavender essential oil, which has been found to have positive effects on many variables in various studies, on the anxiety and comfort levels that may be experienced in patients who will experience colonoscopy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Faculty Of Health Sciences
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Kırklareli, Faculty Of Health Sciences, Turkey
- Kırklareli University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- over 18 years old, 65 years old and under,
- having colonoscopy,
- not having the risk of heart failure and cardiogenic shock (class III and IV),
- not having a history of asthma, eczema, and allergies to flowers and plants,
- not allergic to lavender,
- not having communicative/severe hearing or speech impairment,
- not using antidepressant, antihistamine, diuretic, hypnotic, benzodiazepine and narcotic derivatives
- having stable vital signs
- individuals who volunteered to participate in research
Exclusion Criteria:
- individuals who do not meet the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Pre-procedural information form, state-trait anxiety scale, and comfort scale were applied to patients who had planned colonoscopy. Two drops of lavender (2%) essential oil was dripped onto a 2 x 2 cm cotton gauze cloth attached to the front of the clothes of the experimental group patients, approximately 12 inches below their noses. They were asked to inhale 2% lavender essential oil for 20 minutes. They were directed to breathe normally after inhalation. Vital signs of the patients were checked before and after the procedure. After the process, the forms were filled again, the final test process was completed. |
Two drops of lavender (2%) essential oil were dripped onto a 2 x 2 cm cotton gauze cloth attached to the front of the clothes of the experimental group patients, approximately 12 inches below their noses.
They were asked to inhale 2% lavender essential oil for 20 minutes.
They were directed to breathe normally after inhalation.
Vital signs of the patients were checked before and after the procedure.
After the process, the forms were filled again, the final test process was completed.
|
|
No Intervention: Control Group
Pre-procedural information form, state-trait anxiety scale, and comfort scale were applied to patients who had planned colonoscopy. Lavender aromatherapy was not applied to the patients in this group, but routine care was applied. After the process, the forms were filled again, the final test process was completed. The data took about 15-20 minutes with face-to-face interview method. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of the State-Trait Anxiety Inventory scores
Time Frame: Before the colonoscopic procedure - on colonoscopic procedure day
|
State anxiety inventory determines how an individual feels at a certain moment and under certain conditions. The trait anxiety inventory, on the other hand, is defined as the anxiety that an individual feels in his normal life. Each item in the inventory is evaluated between one and four points. High total scores in the inventories indicate a high state anxiety level of the individual. In the inventory, scores above 42 are considered as "high anxiety level". The internal consistency (Cronbach's Alpha) coefficients of this inventory range from 0.83 to 0.92 for the state anxiety inventory. The State-Trait Anxiety inventory was evaluated 20 minutes before and 20 minutes after colonoscopy in the intervention and control groups. Anxiety level was evaluated with the State-Trait Anxiety inventory before and 20 minutes after lavender oil inhalation in patients in the intervention group. |
Before the colonoscopic procedure - on colonoscopic procedure day
|
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Change of the Overal Comfort Scale
Time Frame: Before the colonoscopic procedure - on colonoscopic procedure day
|
General Comfort Scale: The scale consists of 28 questions and shows the current comfort status of the patient. The score of the scale varies between 28-168. The Cronbach alpha of the 6-point Likert-type scale is 0.82. The general comfort scale was evaluated 20 minutes before and 20 minutes after colonoscopy in the intervention and control groups. Overall comfort level was assessed before and 20 minutes after lavender oil inhalation in patients in the intervention group. A high score on the scale indicates that the general comfort level of the patients is high. |
Before the colonoscopic procedure - on colonoscopic procedure day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aylin AYDIN SAYILAN, Assoc.Prof., Kırklareli Universitiy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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