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IRCT20250111064343N1 IRCT 2025-03-10 Bandare-abbas University of Medical Sciences Investigating the effect of aromatherapy on the anxiety of patients who are candidates for angiography Comparison of the effect of lavender and chamomile scent on anxiety in patients who are candidates for angiography 2025-04-05 anticipated 150 Complete https://irct.ir/trial/82209 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The sampling method of this study is non-probability. In this way, patients who meet the inclusion criteria and complete the consent form to participate in the study will be considered as the study sample of this study until the desired number of samples is completed. Then, using the random block method (selection of 10 blocks of 15), we allocate the sample individuals to one of the three study groups (lavender, chamomile, or placebo) according to the random sequence table extracted in the Randomization Maine software at the Internet address https://www.randomizer.org/, Blinding description: Single-blinding in this study means that the participants simply do not know which scent they will be exposed to. (While the patients are able to identify the scents, they do not know which particular scent is the active intervention being tested.). N/A Anxiety of angiography patients. Intervention 1: Intervention group: First intervention group (aromatherapy with lavender essential oil): After assigning individuals to the intervention and placebo groups, the level of latent and overt anxiety will be measured using the Spielberger questionnaire. The second step: About an hour before angiography, for the lavender aromatherapy group, 2 drops of 10% lavender essential oil (provided by Barij Essential Oil Company) will be poured onto a 10 x 10 cm piece of cloth using a dropper and pinned to the patients' shirts 20 cm from their noses. Then, immediately 20 minutes after the intervention, the patients' level of anxiety will be measured again using the Spielberger questionnaire, and the data will be collected and analyzed. Finally, the results of the interventions between the groups, as well as before and after the intervention, will be analyzed and compared. Intervention 2: Intervention group: Second intervention group (aromatherapy with chamomile essential oil): After assigning individuals to the intervention and placebo groups, the level of latent and overt anxiety will be measured using the Spielberger questionnaire. The second step is that about an hour before angiography, for the aromatherapy with chamomile essential oil group, 2 drops of 10% chamomile essential oil will be poured onto a 10 x 10 cm piece of cloth using a dropper and pinned to the patients' shirts at a distance of 20 cm from their noses. Then, immediately 20 minutes after the intervention, the patients' level of anxiety will be measured again using the Spielberger questionnaire, and data will be collected and analyzed. Finally, the results of the interventions between the groups, as well as before and after the intervention, will be analyzed and compared. Intervention 3: Control group: (Aromatherapy with distilled water): After assigning individuals to the intervention and placebo groups, the level of latent and overt anxiety will be measured using the Spielberger questionnaire. The second step is that about an hour before angiography, for the placebo group, 2 drops of distilled water will be poured onto a 10 x 10 cm piece of cloth using a dropper and pinned to their shirt 20 cm from the patients' noses. Then, immediately 20 minutes after the intervention, the patients' level of anxiety will be measured again using the Spielberger questionnaire, and the data will be collected and analyzed. Finally, the results of the interventions between the groups, as well as before and after the intervention, will be analyzed and compared. Yes - There is a plan to make this available What will be shared: Only information about the outcome When: Since 1403 To whom: The data will be available to all healthcare researchers. Conditions: It will be used for research and educational purposes. Where to obtain: Ms. Niloofar Rabbani, a senior student of surgical nursing at Hormozgan University of Medical Sciences, can be reached via email at niloo.rbn1998@gmail.com and phone number 09301850138. How to obtain: Access to the data file will be possible by sending a request to the author's email. Comments:
public Niloofar Rabbani
Beginning of Imam Hossein Boulevard, Hormozgan University of Medical Sciences, Faculty of Nursing and Midwifery
Bandar abbas Iran (Islamic Republic of) 7919693116 +98 930 185 0138 niloo.rbn1998@gmail.com Bandare-abbas University of Medical Sciences scientific Aref Faghih
Beginning of Imam Hossein Boulevard, Hormozgan University of Medical Sciences, Faculty of Nursing and Midwifery
Bandar abbas Iran (Islamic Republic of) 7919693116 +98 76 3128 5022 aref_faghih@yahoo.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Having informed consent Age range from 18 to 65 years Having complete alertness Absence of any allergy to medicinal plants Candidate patients for coronary angiography for the first time Failure to perform other invasive procedures before angiography (such as echocardiography through the esophagus) Absence of valvular heart disease, any olfactory and respiratory problems, drug addiction, liver and kidney problems. Not taking sedative drugs 4 hours before the intervention 18 years 65 years Both Unwillingness to participate in the study History of any confirmed mental illness, such as depression and anxiety The occurrence of any cardiac dysrhythmias and changes in vital signs and hemodynamics I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris Prevention Prevention Prevention Intervention group: First intervention group (aromatherapy with lavender essential oil): After assigning individuals to the intervention and placebo groups, the level of latent and overt anxiety will be measured using the Spielberger questionnaire. The second step: About an hour before angiography, for the lavender aromatherapy group, 2 drops of 10% lavender essential oil (provided by Barij Essential Oil Company) will be poured onto a 10 x 10 cm piece of cloth using a dropper and pinned to the patients' shirts 20 cm from their noses. Then, immediately 20 minutes after the intervention, the patients' level of anxiety will be measured again using the Spielberger questionnaire, and the data will be collected and analyzed. Finally, the results of the interventions between the groups, as well as before and after the intervention, will be analyzed and compared. Intervention group: Second intervention group (aromatherapy with chamomile essential oil): After assigning individuals to the intervention and placebo groups, the level of latent and overt anxiety will be measured using the Spielberger questionnaire. The second step is that about an hour before angiography, for the aromatherapy with chamomile essential oil group, 2 drops of 10% chamomile essential oil will be poured onto a 10 x 10 cm piece of cloth using a dropper and pinned to the patients' shirts at a distance of 20 cm from their noses. Then, immediately 20 minutes after the intervention, the patients' level of anxiety will be measured again using the Spielberger questionnaire, and data will be collected and analyzed. Finally, the results of the interventions between the groups, as well as before and after the intervention, will be analyzed and compared. Control group: (Aromatherapy with distilled water): After assigning individuals to the intervention and placebo groups, the level of latent and overt anxiety will be measured using the Spielberger questionnaire. The second step is that about an hour before angiography, for the placebo group, 2 drops of distilled water will be poured onto a 10 x 10 cm piece of cloth using a dropper and pinned to their shirt 20 cm from the patients' noses. Then, immediately 20 minutes after the intervention, the patients' level of anxiety will be measured again using the Spielberger questionnaire, and the data will be collected and analyzed. Finally, the results of the interventions between the groups, as well as before and after the intervention, will be analyzed and compared. Anxiety level of angiography candidate patients. Timepoint: Measuring the anxiety level of angiography candidate patients before the intervention and twenty minutes after the intervention. Method of measurement: Spielberger's overt and covert anxiety test questionnaire, whose validity and reliability have been confirmed. Bandare-abbas University of Medical sciences Approved 2025-01-08 Ethics Committee of Hormozgan University of Medical Sciences Nursing and Midwifery Faculty, Hormozgan University of Medical Sciences , Beginning of Imam Hossein Boulevard Bandarabbas Hormozgan Iran (Islamic Republic of)