NCT04596904

Brief Summary

Esophagogastroduodenoscopy and colonoscopy are invasive procedures that enable the diagnosis, diagnosis, treatment, biopsy, photo and video recording of the gastrointestinal tract. It has an important place in clinical use for diagnosis and treatment and these procedures are common. When the studies are examined; while the prevalence of gastroesophageal reflux disease was 8.8% -25.9% in Europe, approximately 20% of the population in the world were found to have dyspeptic complaints. In the UK, 41,000 new colorectal cancers were diagnosed in 2014 and 132700 new cases were detected in the United States in 2015. In the European Union countries, the incidence of gastrointestinal cancer reported in 2012 is 684,000 cases. During endoscopic interventions in our country; in Turkey; people may experience high levels of anxiety considering the negative consequences of discomfort and pain.In such cases, nurses should make attempts to reduce the anxiety of the person by predicting that people may have anxiety. Non-pharmacological methods that may reduce anxiety include; pre-treatment training, aromatherapy, acupuncture, hypnosis. Eliminating or reducing anxiety as much as possible will help increase the comfort of both the patient and the endoscopist in these invasive procedures. In our study, our aim was to evaluate the effect of non-pharmacological methods on the preoperative lavender smell.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

October 15, 2020

Last Update Submit

October 15, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of the State-Trait Anxiety Inventory Scores

    An individual identification form and the State-Trait Anxiety Inventory were used to collect the data.It is a self-assessment questionnaire consisting of short statements.It includes the feature of describing how the individual feels at a certain moment and under certain conditions and responding by taking into account their feelings about the situation. In reliability analysis, Cronbach alpha internal consistency coefficients; 0.94-0.96 for State Anxiety Inventory; it is between 0.83 and 0.87 for the Trait Anxiety Inventory.The unchanged value for the State Anxiety Inventory is 50 and 35 for the Trait Anxiety Inventory. The last obtained value is the individual's anxiety score.

    Before the endoscopic procedure - on endoscopic procedure day

Study Arms (2)

Lavender oil group

EXPERIMENTAL

Individuals, for 10 days, 3 drops of cotton drops of lavender oil, put on the shoulder parts, between 21:00 and 21:05 will smell every evening.

Other: Lavender oil application group

Distilled water group

PLACEBO COMPARATOR

Individuals, for 10 days, 3 drops of cotton drops of distilled water, put on the shoulder parts, between 21:00 and 21:05 will smell every evening.

Other: Distilled water application group

Interventions

Individuals, for 10 days, 3 drops of cotton drops of lavender oil, put on the shoulder parts, between 21:00 and 21:05 will smell every evening.

Lavender oil group

Individuals, for 10 days, 3 drops of cotton drops of distilled water, put on the shoulder parts, between 21:00 and 21:05 will smell every evening.

Distilled water group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatmanur Ince Ozgenel

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Fatmanur Ozgenel, Nurse

    Eskisehir Osmangazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Clinical research with herbal products
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 22, 2020

Study Start

November 1, 2017

Primary Completion

December 31, 2018

Study Completion

May 30, 2019

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations