Anxiety StateNCT04596904
The Effect of Lavender Smell on Anxiety
A study testing Lavender oil application group and Distilled water application group in people with Anxiety State, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety State
- What is being tested?
- Lavender oil application group and Distilled water application group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: The volunteers who will undergo esophagogastroduodenoscopy or colonoscopy to the gastroenterology outpatient clinic were included in the study.
-
Exclusion Criteria: Having cardiovascular disease, Asthma Known history of allergy To be diagnosed psychiatric disease (anxiety / panic attack / depression) To take anxiolytic medication (such as benzodiazepines, selective serotonin reuptake inhibitors, To use products such as antiperspirant, perfume, spray containing any fragrance to the hair and body before the procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lavender Smell on Anxiety Due to Endoscopic Procedures
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.
Read the 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 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
- Conditions
- Anxiety State
- Being tested
- Lavender oil application group, Distilled water application group
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender oil application groupOther
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.
Distilled water application groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Distilled water application group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the endoscopic procedure - on endoscopic procedure day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Nov 2017
- Primary completion31 Dec 2018
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical research with herbal products
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatmanur Ince Ozgenel, Eskisehir Osmangazi University
- Investigators
- Fatmanur Ozgenel, Nurse, Principal investigator, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596904
- Sponsor's protocol ID
- 8680
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lavender Smell on Anxiety Due to Endoscopic Procedures
- ClinicalTrials.gov ID
- NCT04596904
- Acronym / sponsor ID
- 8680
- Conditions
- Anxiety State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical research with herbal products
| Arm | Type | Receives |
|---|---|---|
| Lavender oil group | Experimental | Other: Lavender oil application groupIndividuals, 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. |
| Distilled water group | Placebo comparator | Other: Distilled water application groupIndividuals, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender oil application groupIndividuals, 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 group |
| Distilled water application groupIndividuals, 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 group |
Primary outcome
Change of the State-Trait Anxiety Inventory Scores
Time frame: Before the endoscopic procedure - on endoscopic procedure day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatmanur Ozgenel, Nurse principal investigator
Eskisehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender oil application group and Distilled water application group in people with Anxiety State, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the State-Trait Anxiety Inventory Scores (time frame: Before the endoscopic procedure - on endoscopic procedure day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.