Ignite Creation Date:
2024-07-17 @ 11:17 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482424
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-01
First Post:
2024-06-12
Brief Title:
The Effect of Aromatherapy on Sleep Anxiety and Vital Signs in Those With Essential Hypertension Hypertension
Sponsor:
TC Erciyes University
Organization:
TC Erciyes University
Study Overview
Official Title:
The Effect of Aromatherapy on Sleep Anxiety and Vital Signs in Those With Essential Hypertension
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
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:
hypertension
Brief Summary:
In addition to pharmacological agents in the treatment of hypertension it has been reported in studies that aromatherapy applications one of the traditional and complementary alternative treatments that are easy to apply nursing interventions with minimal side effects have an effect on high blood pressure control Studies have shown that aromatherapy has positive effects on stress management and anxiety control Lavender oil one of the frequently used aromatic oils has antiseptic anti-inflammatory analgesic muscle relaxant effects regulates sleep with its relaxing and sedative effects reduces the severity of itching increases attention and facilitates learning and reduces physical indicators of the autonomic nervous system such as pulse respiratory rate and blood pressure It has been shown in studies that it lowers In this study the effect of lavender aromatic oil on sleep anxiety and vital signs in individuals with essential hypertension will be evaluated In the study lavender oil will be administered to patients by inhalation for 5 minutes twice a day for 4 weeks Medicinal lavender oil will be applied to the intervention group and sesame oil will be applied to the placebo group During the follow-up of the patients the patient follow-up chart-researcher form will be evaluated at the beginning of the first week and at the end of the fourth week for each group Vital signs blood pressure and pulse rate half an hour before and after aromatherapy in the morning and evening 5 days a week for four weeks will be evaluated with the Pittsburgh Sleep Quality Index and State-Trait Anxiety Scale at the beginning of the first week and at the end of the fourth week The unique value of this study is that unlike other studies the applications will be applied in the morning and evening for 4 weeks and sesame oil which does not have an aromatic effect will be used in the placebo group As an expected patient outcome we foresee improving the quality of life of patients by improving their sleep quality reducing their anxiety level and lowering their blood pressure by taking advantage of the healing effect of lavender aromatic oil in nursing practices
Detailed Description:
METHOD OF THE THESIS
PURPOSE AND TYPE OF RESEARCH This study will be conducted as a randomized controlled experimental study to determine the effect of aromatherapy on sleep anxiety and vital signs in individuals with essential hypertension
HYPOTHESES H01 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has no effect on systolic blood pressure in patients with Essential Hypertension
H11 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has an effect on systolic blood pressure in patients with Essential Hypertension
H02 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has no effect on diastolic blood pressure in patients with Essential Hypertension
H12 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has an effect on diastolic blood pressure in patients with Essential Hypertension
H03 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has no effect on pulse rate in patients with Essential Hypertension
H13 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has an effect on pulse rate in patients with Essential Hypertension
H04 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has no effect on anxiety level in patients with Essential Hypertension
H14 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has an effect on the anxiety level in patients with Essential Hypertension
H05 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has no effect on sleep level in patients with Essential Hypertension
H15 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has an effect on sleep level in patients with Essential Hypertension
ETHICAL ASPECTS OF RESEARCH In order to conduct the research Erciyes University Faculty of Health Sciences Department of Nursing Academic Board Decision Niğde Bor State Hospital Institutional Permission and TR Ministry of Health Kayseri City Hospital GETAT Clinical Research Ethics Committee Approval will be obtained The purpose of the research will be explained to the individuals participating in the research and written voluntary consent will be obtained
PLACE AND TIME WHERE THE RESEARCH WILL BE CONDUCTED will be collected from patients treated at the internal medicine outpatient clinic of Niğde Bor State Hospital between 1505-2024-31122024 Bor State Hospital has a capacity of 100 beds and employs 407 personnel Bor State Hospital offers internal medicine cardiology gynecology ophthalmology orthopedics general surgery child health and diseases skin and venereal diseases anesthesiology and reanimation psychiatry infection urology outpatient clinic service and general surgery internal medicine urology orthopedics women Obstetrics ophthalmology internal medicine infection cardiology child health and diseases skin and venereal diseases general intensive care neonatal intensive care clinic services are provided In the Bor State Hospital internal medicine outpatient clinic patients who are not compliant with treatment and have a lack of knowledge are given training by a training nurse upon the request of a doctor Drug treatment is administered to patients diagnosed with hypertension in the internal medicine outpatient clinic
UNIVERSE AND SAMPLING OF THE RESEARCH consists of patients who were treated in the internal medicine outpatient clinic at Niğde Bor State Hospital between January 2022 and December 2022 It was planned to include at least 20 people with essential hypertension in the intervention group and at least 20 people in the placebo group in the study sample Groups will be selected according to similar characteristics in terms of variables such as gender age the contact information of the patients who voluntarily participate in the study and meet the study conditions After visiting the patients at home the patients allergy status will be observed by applying oil to the patients wrist one day before starting aromatherapy Patients without allergies will be evaluated in terms of the inclusion criteria and the study will be conducted with patients who meet the criteria
COLLECTION OF DATA Actions to be taken to the Intervention Group Before the research patients will be informed about the purpose and method of the study and then their approval will be obtained through an informed consent form A personal information form will be filled out by the researcher for the patients in the intervention group and an individual in-depth interview will be conducted with the questions in the oil application patient opinions form The researcher will measure the temperature respiratory rate saturation level blood pressure and pulse of the patients in the intervention group at their homes and will record them in the patient follow-up chart-researcher form In the following days patients will be called by phone and reminded to measure their blood pressure and pulse with a semi-automatic blood pressure monitor and record it on the patient follow-up chart-researcher form In line with the lavender oil application protocol patients in the intervention group will drop medical lavender oil on gauze and smell it for 5 minutes every morning and evening for 4 weeks The patient will be instructed and reminded to record hisher blood pressure and pulse rate on the patient monitoring chart-researcher form five days a week half an hour before and after aromatherapy in the morning and evening for 4 weeks
The state-trait anxiety scale and Pittsburg Sleep Quality Index score will be recorded on the patient follow-up chart-researcher form by the researcher at the patients home at the beginning of the first week and at the end of the fourth week The aromatic oil given to patients in the intervention group will be placed in 10ml dark glass bottles with droppers and a numbered label will be attached to the bottle
PURPOSE AND TYPE OF RESEARCH This study will be conducted as a randomized controlled experimental study to determine the effect of aromatherapy on sleep anxiety and vital signs in individuals with essential hypertension
HYPOTHESES H01 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has no effect on systolic blood pressure in patients with Essential Hypertension
H11 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has an effect on systolic blood pressure in patients with Essential Hypertension
H02 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has no effect on diastolic blood pressure in patients with Essential Hypertension
H12 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has an effect on diastolic blood pressure in patients with Essential Hypertension
H03 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has no effect on pulse rate in patients with Essential Hypertension
H13 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has an effect on pulse rate in patients with Essential Hypertension
H04 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has no effect on anxiety level in patients with Essential Hypertension
H14 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has an effect on the anxiety level in patients with Essential Hypertension
H05 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has no effect on sleep level in patients with Essential Hypertension
H15 Lavender oil applied by inhalation for 5 minutes twice a day for 4 weeks has an effect on sleep level in patients with Essential Hypertension
ETHICAL ASPECTS OF RESEARCH In order to conduct the research Erciyes University Faculty of Health Sciences Department of Nursing Academic Board Decision Niğde Bor State Hospital Institutional Permission and TR Ministry of Health Kayseri City Hospital GETAT Clinical Research Ethics Committee Approval will be obtained The purpose of the research will be explained to the individuals participating in the research and written voluntary consent will be obtained
PLACE AND TIME WHERE THE RESEARCH WILL BE CONDUCTED will be collected from patients treated at the internal medicine outpatient clinic of Niğde Bor State Hospital between 1505-2024-31122024 Bor State Hospital has a capacity of 100 beds and employs 407 personnel Bor State Hospital offers internal medicine cardiology gynecology ophthalmology orthopedics general surgery child health and diseases skin and venereal diseases anesthesiology and reanimation psychiatry infection urology outpatient clinic service and general surgery internal medicine urology orthopedics women Obstetrics ophthalmology internal medicine infection cardiology child health and diseases skin and venereal diseases general intensive care neonatal intensive care clinic services are provided In the Bor State Hospital internal medicine outpatient clinic patients who are not compliant with treatment and have a lack of knowledge are given training by a training nurse upon the request of a doctor Drug treatment is administered to patients diagnosed with hypertension in the internal medicine outpatient clinic
UNIVERSE AND SAMPLING OF THE RESEARCH consists of patients who were treated in the internal medicine outpatient clinic at Niğde Bor State Hospital between January 2022 and December 2022 It was planned to include at least 20 people with essential hypertension in the intervention group and at least 20 people in the placebo group in the study sample Groups will be selected according to similar characteristics in terms of variables such as gender age the contact information of the patients who voluntarily participate in the study and meet the study conditions After visiting the patients at home the patients allergy status will be observed by applying oil to the patients wrist one day before starting aromatherapy Patients without allergies will be evaluated in terms of the inclusion criteria and the study will be conducted with patients who meet the criteria
COLLECTION OF DATA Actions to be taken to the Intervention Group Before the research patients will be informed about the purpose and method of the study and then their approval will be obtained through an informed consent form A personal information form will be filled out by the researcher for the patients in the intervention group and an individual in-depth interview will be conducted with the questions in the oil application patient opinions form The researcher will measure the temperature respiratory rate saturation level blood pressure and pulse of the patients in the intervention group at their homes and will record them in the patient follow-up chart-researcher form In the following days patients will be called by phone and reminded to measure their blood pressure and pulse with a semi-automatic blood pressure monitor and record it on the patient follow-up chart-researcher form In line with the lavender oil application protocol patients in the intervention group will drop medical lavender oil on gauze and smell it for 5 minutes every morning and evening for 4 weeks The patient will be instructed and reminded to record hisher blood pressure and pulse rate on the patient monitoring chart-researcher form five days a week half an hour before and after aromatherapy in the morning and evening for 4 weeks
The state-trait anxiety scale and Pittsburg Sleep Quality Index score will be recorded on the patient follow-up chart-researcher form by the researcher at the patients home at the beginning of the first week and at the end of the fourth week The aromatic oil given to patients in the intervention group will be placed in 10ml dark glass bottles with droppers and a numbered label will be attached to the bottle
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