Protocol summary
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Study aim
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Comparison of the effect of aromatherapy with Damask rose and chamomile essential oil on anxiety level, pain intensity and hemodynamic variables in patients candidates for emergency surgery.
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Design
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This study will be a randomized clinical trial with three groups (two intervention groups and one control group).To allocate the samples to the study groups randomly, the random permutation block design of three treatments with six blocks will be used; which will be considered A (for the frozen flower group), B (for the chamomile group) and C (for the control group). Then the website https://www.sealedenvelope.com will be used to determine the required random blocks and their sequence.
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Settings and conduct
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The research environment will be the male and female surgery wards of Zanjan medical science teaching hospitals.
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Participants/Inclusion and exclusion criteria
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People over 18 years of age (to ensure the expressed sense), The patient's desire to participate in the study, Having clear verbal ability, Not having a history of allergy and sensitivity to chamomile and Damask rose, Having a healthy sense of smell and Having no history of surgery on the jaw, face and nose and systemic or chronic diseases affecting the sense of smell or hearing, There is no history of mental illness and chronic anxiety diseases known based on the patient's speech and his family.
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Intervention groups
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Aromatherapy group with Damask rose essential oil (group A) - Aromatherapy group with chamomile essential oil (group B) - Control group with distilled water (group C)
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Main outcome variables
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Anxiety; Pain; Vital signs
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220827055802N1
Registration date:
2022-09-14, 1401/06/23
Registration timing:
prospective
Last update:
2022-10-01, 1401/07/09
Update count:
1
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Registration date
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2022-09-14, 1401/06/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-09-23, 1401/07/01
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Expected recruitment end date
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2022-12-22, 1401/10/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison between the effect of aromatherapy with Chamomile and Damask Rose (Rosa damascene mill) on anxiety and pain in emergency surgery patients
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Public title
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Comparison between the effect of aromatherapy with Chamomile and Damask Rose (Rosa damascene mill) on anxiety and pain in emergency surgery patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
1- People over 18 years of age (to ensure the expressed sense)
2- The patient's desire to participate in the study
3- Having clear verbal ability
Exclusion criteria:
1- having a history of allergy and sensitivity to chamomile and Damask Rose
2- There is history of mental illness and chronic anxiety diseases known based on the patient's speech and his family.
3- Unhealthy sense of smell and having a history of surgery on the jaw, face and nose and systemic or chronic diseases affecting the sense of smell or hearing
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
38
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To allocate the samples to the study groups randomly, a random permutation block design of three treatments with six blocks will be used, which is A (for the Damask Rose group), B (for the chamomile group) and C (for the control group ) will be considered. Then, the website: https://www.sealedenvelope.com will be used to determine the required random blocks and their sequence.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-08-23, 1401/06/01
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Ethics committee reference number
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IR.ZUMS.REC.1401.183
Health conditions studied
1
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Description of health condition studied
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All candidates for emergency surgery in the field of orthopedics with a closed injury of a limb, such as fractures and sprains, tendon injuries, and joint and ligament injuries in the hands or feet.
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ICD-10 code
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G89.11
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ICD-10 code description
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Acute pain due to trauma
Primary outcomes
1
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Description
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Anxiety level on the visual analogue scale of anxiety
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Timepoint
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Measuring the level of anxiety before the intervention, after three intervention periods, in the morning before the operation
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Method of measurement
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Visual Analogue Scale of Anxiety
2
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Description
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Pain intensity on a visual analog scale
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Timepoint
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Pain intensity measurement before the intervention, after three intervention periods, in the morning before the operation
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Method of measurement
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visual analog scale
Secondary outcomes
1
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Description
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Vital Signs
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Timepoint
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Before and after performing 3 intervention courses and on the morning of the operation day while transferring the patient to the operating room
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Method of measurement
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A nurse will be used to count the patient's breaths in one minute. For pulse and blood pressure, the standard portable monitor device calibrated by the medical equipment unit of the hospital will be used by the same nurse
Intervention groups
1
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Description
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The first intervention group: Damask rose group, the use of 40% Damask rose essential oil as aromatherapy, the total time of the intervention at the night before the operation is 3 times each time for 1 hour, with 3 drops in each hour and a total of 9 drops in 3 hours. The essential oil purchased from Zarband company will be used
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Category
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Treatment - Drugs
2
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Description
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The second intervention group: Chamomile group, the use of 40% Chamomile essential oil as aromatherapy, the total time of the intervention at the night before the operation is 3 times each time for 1 hour, with 3 drops in each hour and a total of 9 drops in 3 hours. The essential oil purchased from Zarband company will be used
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Category
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Treatment - Drugs
3
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Description
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Control group: Distilled water group, use of distilled water as aromatherapy, the total time of the intervention the night before the operation is 3 times for 1 hour each time, where 3 drops will be used every hour and a total of 9 drops will be used in 3 hours.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zanjan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable