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Completed

NCT Number: NCT05540418

Effect of Lavender Oil Inhalation in Colonoscopy Patients

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.

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Key information

Conditions

Colonic Disease Anxiety Disorders Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Mental Disorders

Age range

44 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kırklareli University

Kırklareli, Faculty of Health Sciences, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Collaborators

  • Kırklareli University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2022
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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