Effect of Lavender Oil Inhalation in Colonoscopy Patients

NCT05540418 | Completed

• 1 other identifier: 2022/03
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Disease

Keywords

colonoscopy; aromatherapy; anxiety; comfort; lavander oil

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Other: lavender oil inhalation

Control Group

NO INTERVENTION

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.

Interventions

lavender oil inhalation OTHER

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.

Experimental group

Eligibility Criteria

• Age: 44 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead
• Kırklareli University: collaborator

Study Sites (1)

Kırklareli University

Kırklareli, Faculty of Health Sciences, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colonic Diseases; Anxiety Disorders

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Mental Disorders

Study Officials

• Aylin AYDIN SAYILAN, Assoc.Prof.

  Kırklareli Universitiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Model Details: Randomized controlled experimental study

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 14, 2022
• Study Start: June 15, 2022
• Primary Completion: August 15, 2022
• Study Completion: September 3, 2022
• Last Updated: October 10, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)