Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04596904 |
| Other study ID # |
8680 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2017 |
| Est. completion date |
May 30, 2019 |
Study information
| Verified date |
October 2020 |
| Source |
Eskisehir Osmangazi University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Type and purpose of the study: This randomized controlled trial was planned to evaluate the
effect of volatile lavender oil on the level of instantaneous and sustained anxiety level of
the patients undergoing endoscopic procedure.
Time and place of study:
The research is carried out in Eskişehir Osmangazi University Gastroenterology Polyclinic.
Universe and sample: The population of the study was applied to the gastroenterology
outpatient clinic for diagnosis and diagnosis. The sample of the research sample will be
composed of people who meet the sample selection criteria in the specified
universe.Chi-Square Test Power analysis was used to determine the sample number of the study.
The statistical power was calculated as 118 people with 82%, alpha 0.05, beta 0,1741 errors
and 59 persons in group A and 59 persons in group B. In the calculation of the power
analysis, Hu et al. (2010) evaluated the effect of lavender in the management of anxiety
related to colonoscopy.
Randomization: Within the scope of the study, written consent was obtained after the
individuals were informed by the researchers. Randomization method was randomized to two
groups [(lavender oil group (A), control group (B)]. The registration numbers and the group
numbers of the individuals will be delivered to the researchers in a closed envelope and the
lavender oil / distilled water will be sniffed according to the group of the individual
before the procedure.
There are differences in the level of anxiety related to esophagogastroduodenoscopy and
colonoscopy. For this reason, randomization of the patients to groups will be tried to be
matched with the case of esophageogudroduodenoscopy and colonoscopy. Patients in the same
group of patients will also be included in group B according to the type of procedure in each
group (esophagogastroduodenoscopy / colonoscopy).
Preparation of aromatic oils: In the light of the information obtained from the studies
evaluating the effect of lavender oil on anxiety, lavender oil with a sedative effect was
used in one group, while the other group was determined to use jojoba, sunflower, jasmine,
rosemary, grape seed, tea tree oils without sedative effect.
Lavender oil (Lavandula hybrida): The volatile lavender oil to be used for the enterprise
will be taken from a reliable plant product company and the company has got the operation
registration and TS EN ISO 9001: 2008 quality certificates from the Ministry of Food,
Agriculture and Livestock by G06-3231. After 10 days of 3 drops of lavender oil on the cotton
pad, the prepared cotton pad will be placed on the shoulder dress. Application and
evaluation: The data of the study will be collected in the first and second stage in a total
of 2 weeks; First stage:Individual presentation form, State Trait Anxiety Inventory-I, II
will be applied to the individuals who have been given an appointment to perform
esophagogastroduodenoscopy and colonoscopy in the gastroenterology outpatient clinic, then A
and B group individuals will be informed by the healthcare professional about the application
of lavender oil / distilled water at home. For 10 days at home, group A patients receive
lavender oil; Group B patients will smell distilled water every evening between 21.00-21.05
for 5 minutes.
Second stage: State Trait Anxiety Inventory-I, II will be filled before sedation in patients
coming to the outpatient clinic for esophagogastroduodenoscopy and colonoscopy, vital signs
(heart rate, respiratory rate, blood pressure arterial) to be evaluated and the sedation
protocol prescribed by the physician. No changes shall be made to the screening, diagnosis
and treatment of individuals during the trial.
Individual presentation form: Socio-demographic characteristics of patients (age, gender,
educational status, marital status, information to support the patient's care) and
disease-related features (diagnosis, treatment, duration of disease) is a form of questions
about.
State Trait Anxiety Inventory (I, II) is a self-assessment questionnaire consisting of short
expressions. This is a Likert-type scale, a four-degree scale ranging from None "to"
Completely. It includes the description of how an individual feels himself / herself in a
certain moment and under certain conditions and taking into account his / her feelings about
the situation he / she is in. Cronbach alpha internal consistency coefficients in reliability
analysis;0.94-0.96 for State Anxiety Inventory, for The Trait Anxiety Inventory is between
0.83 and 0.87. There are two types of expressions in State-Trait Anxiety Inventories. Direct
expressions express negative feelings and reversed expressions express positive feelings. In
the State Anxiety Inventory, the terms reversed are 1,2,5,8,10,11,15,16,19 and 20 items. On
the Trait Anxiety Inventory, the inverse statements constitute 21,26,27,30,33,36 and 39th
items. After the total weight of the direct and inverted expressions are found, the total
weight score of the reverse expressions is subtracted from the total weight score obtained
for the direct expressions. A predetermined and unchanged value is added to this number. This
constant value is 50 for the State Anxiety Inventory and is 35 for the Trait Anxiety
Inventory. The recent value is an individual's anxiety score
