Effect of Lavender Oil Inhalation in Colonoscopy Patients

Colonic Disease Clinical Trial

Official title:

The Effect of Lavender Oil Inhalation on Anxiety and Comfort in Patients Undergoing Colonoscopy: A Randomized Controlled, Single-center Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05540418
• Other study ID #: 2022/03
• Status: Completed
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: September 3, 2022

Study information

• Verified date: September 2022
• Source: Kirsehir Ahi Evran University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: September 3, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 44 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Disease
• Colonic Diseases

Intervention

Other:
• lavender oil inhalation
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.

Locations

Country	Name	City	State
Turkey	Kirklareli University	Kirklareli	Faculty Of Health Sciences

Sponsors (2)

Lead Sponsor	Collaborator
Kirsehir Ahi Evran University	Kirklareli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the State-Trait Anxiety Inventory scores	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
Primary	Change of the Overal Comfort Scale	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