Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04596904
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2020-10-15
Brief Title:
The Effect of Lavender Smell on Anxiety
Sponsor:
Eskisehir Osmangazi University
Organization:
Eskisehir Osmangazi University
Study Overview
Official Title:
The Effect of Lavender Smell on Anxiety Due to Endoscopic Procedures
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 88 -259 in Europe approximately 20 of the population in the world were found to have dyspeptic complaints In the UK 41000 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 684000 cases
During endoscopic interventions in our country in Turkey people may experience high levels of anxiety considering the negative consequences of discomfort and painIn 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
During endoscopic interventions in our country in Turkey people may experience high levels of anxiety considering the negative consequences of discomfort and painIn 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
Detailed 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 universeChi-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 005 beta 01741 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 stageIndividual 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 2100-2105 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 patients 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 analysis094-096 for State Anxiety Inventory for The Trait Anxiety Inventory is between 083 and 087 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 12581011151619 and 20 items On the Trait Anxiety Inventory the inverse statements constitute 212627303336 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 individuals anxiety score
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 universeChi-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 005 beta 01741 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 stageIndividual 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 2100-2105 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 patients 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 analysis094-096 for State Anxiety Inventory for The Trait Anxiety Inventory is between 083 and 087 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 12581011151619 and 20 items On the Trait Anxiety Inventory the inverse statements constitute 212627303336 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 individuals anxiety score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None