Effect of Aromatherapy on Pain Intensity for Patients Undergoing Arterial Sheath Removal after Percutaneous Coronary Intervention: A Randomized Controlled Trial
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Protocol summary
Ibn-AL-Baiter center of cardiac surgery in Baghdad city
Ibn-Al-Nafees Educational Hospital for cardiovascular Surgery
Ibn-ALAl-Baiter center of cardiac surgery in Baghdad cityNafees Educational Hospital for cardiovascular Surgery
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 5 minutes before arterial sheath removal and persist to 10 minutes after 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.
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.
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 520 minutes before arterial sheath removal and persist to 10 minutes after 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.
General information
119
77
11977
empty
The sample size need to change
The sample size need to change
Health conditions studied
#1
empty
Z. 95.5
Z. 95.5
empty
Z. 95.5
Z. 95.5
empty
Patients undergoing arterial sheath removal after precutaneous coronary intervention
Patients undergoing arterial sheath removal after precutaneous coronary intervention
Intervention groups
#1
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 5 minutes before arterial sheath removal and persist to 10 minutes after 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.
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.
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 520 minutes before arterial sheath removal and persist to 10 minutes after 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.
Protocol summary
Study aim
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.
Design
Randomized control trial design (RCT), to find out the effect of aromatherapy on pain intensity for patients undergoing arterial sheath removal after PCI
Settings and conduct
Ibn-Al-Nafees Educational Hospital for cardiovascular Surgery
Participants/Inclusion and exclusion 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, 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.
Intervention groups
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.
Main outcome variables
reduced pain intensity caused by arterial sheath removal following percutaneous coronary intervention.
General information
Reason for update
The sample size need to change
Acronym
IRCT registration information
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
Registration date
2023-12-13, 1402/09/22
Registrant information
Name
Ghofran AL-Mussawi
Name of organization / entity
University of Baghdad /Collage of Nursing
Country
Iraq
Phone
+964 781 073 6200
Email address
ghofran.hadi2202m@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-20, 1402/09/29
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Aromatherapy on Pain Intensity for Patients Undergoing Arterial Sheath Removal after Percutaneous Coronary Intervention: A Randomized Controlled Trial
Public title
Effect of Aromatherapy on Pain Intensity for Patients Undergoing Arterial Sheath Removal after Percutaneous Coronary Intervention: A Randomized Controlled Trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
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.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
77
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Single blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in collage of Nursing at University of Baghdad
Street address
Bab-Al-Muadhim
City
Iraq
Postal code
N/A
Approval date
2023-11-22, 1402/09/01
Ethics committee reference number
1510
Health conditions studied
1
Description of health condition studied
PCI
ICD-10 code
Z95.5
ICD-10 code description
Presence of coronary angioplasty implant and graft
2
Description of health condition studied
Patients undergoing arterial sheath removal after precutaneous coronary intervention
ICD-10 code
Z. 95.5
ICD-10 code description
Z. 95.5
Primary outcomes
1
Description
the primary outcome variable that may reduced pain causedby arterial sheath removal
Timepoint
after 20 minutes post intervention
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
N/A
2
Description
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.