Protocol summary
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Study aim
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1. To assess the effect of aromatherapy on reducing pain intensity in patients after arterial sheath removal following PCI.
2. To find out the association between patients' demographics and their level of pain in response to aromatherapy after sheath removal following PCI.
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Design
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Randomized control trial design (RCT), to find out the effect of aromatherapy on pain intensity for patients undergoing arterial sheath removal after PCI
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Settings and conduct
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Ibn-Al-Nafees Educational Hospital for cardiovascular Surgery
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Participants/Inclusion and exclusion criteria
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The criteria that must be found in the sample to be included in the study are adult patients above 18 years old, undergoing PCI, both male and female, and conscious patients. and the excluded criteria In this study, Patients who refuse to participate in the study, patients with a chronic respiratory disorder (asthma and chronic obstructive pulmonary disease), with allergies to plants and perfumes, with mental state disorder, unconscious patients, and patients with visual, and olfactory disorders.
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Intervention groups
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All patients were male and female lying in the supine position in the catheterization unit following PCI, the arterial sheath was removed after 4 hours post-PCI, and manual pressure was placed by a nurse for 20 minutes on a femoral artery in the groin area. The three drops of lavender oil by dropper on sterile gauze which was tied to the collar of the participants for inhalation to 20 minutes before arterial sheath removal . After that, the VAS was measured to assess the intensity of pain that assessed when the patient mentioned a point on the VAS line that represents the perception of pain.
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Main outcome variables
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reduced pain intensity caused by arterial sheath removal following percutaneous coronary intervention.
General information
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Reason for update
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The sample size need to change
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20231027059870N1
Registration date:
2023-12-13, 1402/09/22
Registration timing:
prospective
Last update:
2024-08-08, 1403/05/18
Update count:
1
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Registration date
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2023-12-13, 1402/09/22
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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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2023-12-20, 1402/09/29
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Expected recruitment end date
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2024-01-20, 1402/10/30
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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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Effect of Aromatherapy on Pain Intensity for Patients Undergoing Arterial Sheath Removal after Percutaneous Coronary Intervention: A Randomized Controlled Trial
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Public title
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Effect of Aromatherapy on Pain Intensity for Patients Undergoing Arterial Sheath Removal after Percutaneous Coronary Intervention: A Randomized Controlled Trial
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
The criteria that must be found in the sample to be included in the study are adult patients above 18 years old.
undergoing PCI.
both male and female.
conscious patients.
Exclusion criteria:
The excluded criteria in this study, are patients who have chronic respiratory disorders such as asthma and chronic obstructive pulmonary disease.
individuals sensitive to the inhalation of perfumes that could lead to airway irritants.
individual with allergies to plants.
patients with mental state disorders.
unconscious patients.
individual with visual impairments.
individuals with olfactory disorders.
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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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N/A
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Groups that have been masked
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Sample size
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Target sample size:
77
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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simple random by using two cards blue and red put in the box the blue card represented the study group which were the patients who were given lavender, and the placebo group who received distilled water. Then all participants were allowed to choose one of these cards
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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To achieve single blind in this research, lavender oil is prepared for the intervention group and distilled water for the control group. Then, the treatments are named with symbols or numbers and the identity of each treatment is kept secret. Treatments are randomized, and the pain assess to rate pain intensity without knowing the type of treatment received, ensuring that participants' expectations do not influence the results. These procedures reduce the influence of prior expectations and ensure an effective study.
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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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2023-11-22, 1402/09/01
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Ethics committee reference number
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1510
Health conditions studied
1
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Description of health condition studied
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PCI
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ICD-10 code
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Z95.5
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ICD-10 code description
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Presence of coronary angioplasty implant and graft
2
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Description of health condition studied
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Patients undergoing arterial sheath removal after precutaneous coronary intervention
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ICD-10 code
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Z. 95.5
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ICD-10 code description
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Z. 95.5
Primary outcomes
1
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Description
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the primary outcome variable that may reduced pain causedby arterial sheath removal
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Timepoint
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after 20 minutes post intervention
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Method of measurement
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visual analog scale
Intervention groups
1
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Description
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in the intervention group The three drops of lavender oil by dropper on sterile gauze which was tied to the collar of the participants for inhalation to 20 minutes before arterial sheath removal. After that, the VAS was measured to assess the intensity of pain that assessed when the patient mentioned a point on the VAS line that represents the perception of pain.
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Category
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N/A
2
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Description
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in the control group, the placebo group, which received 3 drops of distilled water applied on sterile gauze, and also tied to the collar of participants at the same time as the intervention group. after that measuring pain intensity by using VAS.
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Category
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Other
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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No
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Title of funding source
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The author of the trial is the funding source
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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the data will be the results of the VAS that measure the pain intensity of patients undergoing arterial sheath removal
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When the data will become available and for how long
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Once the process of data collection, analysis, and successful publishing of the manuscript, all the related files will become available
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To whom data/document is available
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which academic nurse and any researcher who is interested in the data
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Under which criteria data/document could be used
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The data could be used after getting the permission via email. Also, users need to acknowledge
the owner.
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From where data/document is obtainable
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Users can ask for the data and permission via email at ghofran.hadi2202m@conursing.uobaghdad.edu.iq
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What processes are involved for a request to access data/document
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N/A
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Comments
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