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Effect of Lavender Oil Inhalation in Colonoscopy Patients

Primary Purpose

Colonic Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
lavender oil inhalation
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colonic Disease focused on measuring colonoscopy, aromatherapy, anxiety, comfort, lavander oil

Eligibility Criteria

44 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kırklareli University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 4, 2022
Last Updated
October 6, 2023
Sponsor
Kirsehir Ahi Evran University
Collaborators
Kırklareli University
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1. Study Identification

Unique Protocol Identification Number
NCT05540418
Brief Title
Effect of Lavender Oil Inhalation in Colonoscopy Patients
Official Title
The Effect of Lavender Oil Inhalation on Anxiety and Comfort in Patients Undergoing Colonoscopy: A Randomized Controlled, Single-center Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
September 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University
Collaborators
Kırklareli University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Disease
Keywords
colonoscopy, aromatherapy, anxiety, comfort, lavander oil

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled experimental study
Masking
Participant
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
lavender oil inhalation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of the State-Trait Anxiety Inventory scores
Description
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.
Time Frame
Before the colonoscopic procedure - on colonoscopic procedure day
Title
Change of the Overal Comfort Scale
Description
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.
Time Frame
Before the colonoscopic procedure - on colonoscopic procedure day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
44 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aylin AYDIN SAYILAN, Assoc.Prof.
Organizational Affiliation
Kırklareli Universitiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kırklareli University
City
Kırklareli
State/Province
Faculty Of Health Sciences
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Lavender Oil Inhalation in Colonoscopy Patients

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