Evaluate the effects lavender , Peppermint and Rose oil aromatherapy inhalation for reducing level pain and anxiety associated with cannulation arteriovenous fistula for patients undergoing hemodialysis
Design
(Randomized Controlled Trial)
Settings and conduct
this study will be conducted at Al-Sayyab Teaching Hospital, Al-Basra Teaching Hospital, Basra Dialysis Center and Al-Zubair Dialysis Center.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Their being at least 18 years old.
Agreeing to participate in study.
Undergoing conventional hemodialysis twice or more than times a week.
Obtaining a visual analog scale (VAS) mild pain score or higher during AVF insertion.
Exclusion criteria:
patient within hepatic or as heart failure disease.
panic disorder.
Not good function fistula.
Use analgesic drugs within two hours before hemodialysis procedures.
Pregnant woman.
Intervention groups
To perform lavender,peppermint and rose oil: Before the administration to application , two drops of oils essential oil was applied to the forearm region of participants in the group ( initial interview), and were test for any allergy sign such as erythema, rash, and swelling on the administrated region area. The essential oils that will be given to participations in groups lavender ,peppermint and rose are 100% pure. After pouring 200cc of boiling water into a bowl, five drops will be dripped into the bowl and patients will be inhalation at a distance of approximately 30 cm for five minutes. Patients will be completely covered with a cloth and advice to closed their eyes and deeply inhalation.
Main outcome variables
lavender, peppermint and rose oil pain and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241112063678N1
Registration date:2024-11-28, 1403/09/08
Registration timing:prospective
Last update:2024-11-28, 1403/09/08
Update count:0
Registration date
2024-11-28, 1403/09/08
Registrant information
Name
Abdulrazaq Abdulrahman Khalid Alfarih
Name of organization / entity
University of Baghdad
Country
Iraq
Phone
+964 773 138 4575
Email address
abd.abd2302m@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-01, 1403/09/11
Expected recruitment end date
2025-02-01, 1403/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Lavender, Peppermint and Rose Oil on Pain and Anxiety Associated with Arteriovenous Fistula Cannulation in Hemodialysis Patients
Public title
Effect Aromatherapy in Hemodialysis Patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Their being at least 18 years old.
Agreeing to participate in study.
Undergoing conventional hemodialysis twice or more than times a week.
Obtaining a visual analog scale (VAS) mild pain score or higher during AVF insertion.
No allergy to aroma oils.
No diagnostic with chronic obstructive pulmonary diseases (COPD).
No loss in the sense of smell.
Healthy AVF access.
Speak Arabic.
fistula cannulation not exceed one year.
Exclusion criteria:
patient within hepatic or as heart failure disease.
persistent bleeding.
panic disorder.
Not good function fistula.
Use analgesic drugs within two hours before hemodialysis procedures.
Pregnant woman.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method involves simple random sampling to obtain representative elements of populations. The sampling procedure includes a small colored ball containing three colors (white, black, green and red) and will give each patient the choice of one color. Each color represents one of three groups. White = control group. Black = lavender group. Green= peppermint group. Red = rose group.
This method aims to eliminate bias in intervention assignments, greatly growing the ability to generalize study findings. Additionally, since the number of participant's variation daily, simple random sampling confirm to be the most efficient method for sampling.
Blinding (investigator's opinion)
Single blinded
Blinding description
The sampling procedure includes a small colored ball containing three colors (white, black, green and red) and will give each patient the choice of one color. Each color represents one of three groups. White = control group. Black = lavender group. Green= peppermint group. Red = rose group.
This method aims to eliminate bias in intervention assignments, greatly growing the ability to generalize study findings.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Baghdad College of Nursing
Street address
Bab almuadham ,Baghdad
City
Baghdad
Postal code
10011
Approval date
2024-10-28, 1403/08/07
Ethics committee reference number
9
Health conditions studied
1
Description of health condition studied
Preparatory care for renal dialysis
ICD-10 code
Z49.0
ICD-10 code description
Preparatory care for renal dialysis
Primary outcomes
1
Description
The primary outcomes variable is level pain and anxiety associated with arteriovenous fistula changed after inhalation oils
Timepoint
During intervention and 30 minutes after intervention
Method of measurement
Visual Analog Scale and The Arabic version of State and Trait Anxiety Invetory (STAI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before the administration to application , two drops of lavender,peppermint and rose essential oisl was applied to the forearm region of participants in the group ( initial interview), and were test for any allergy sign such as erythema, rash, and swelling on the administrated region area. The essential oil that will be given to participations in group lavender,peppermint and rose are 100% pure. After pouring 200cc of boiling water into a bowl, five drops will be dripped into the bowl and patients will be inhalation at a distance of approximately 30 cm for five minutes. Patients will be completely covered with a cloth and advice to closed their eyes and deeply inhalation.
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University of Baghdad
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Baghdad
Full name of responsible person
Abdulrazaq Abdulrahman Khalid
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
AL-zubair
City
AL-zubair
Province
AL-basrah
Postal code
61001
Phone
+964 773 138 4575
Email
abd.abd2302m@conursing.uobaghdad.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Baghdad
Full name of responsible person
Abdulrazaq Abdulrahman Khalid
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
AL-zubair
City
AL-zubair
Province
AL-basrah
Postal code
61001
Phone
+964 773 138 4575
Email
abd.abd2302m@conursing.uobaghdad.edu.iq
Person responsible for updating data
Contact
Name of organization / entity
University of Baghdad
Full name of responsible person
Abdulrazaq Abdulrahman Khalid
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
AL-zubair
City
AL-zubair
Province
AL-basrah
Postal code
61001
Phone
+964 773 138 4575
Email
abd.abd2302m@conursing.uobaghdad.edu.iq
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data will be the results of the VAS and STAIs that measures pain and anxiety level in both control and intervention group
When the data will become available and for how long
God Willing, once the article is published, the data will be available after 6 months of publication.
If the article will be published in a subscribed journal, the data will be available after one year
because of the policy of the subscribed journals.
To whom data/document is available
With academic nurses and any researcher who is interested in the data
Under which criteria data/document could be used
the data could be used after getting the permission via email .Also, users need to acknowledge the owner
From where data/document is obtainable
Users can ask for the data and the permission via email. Abdulrazaq Abdulrahman Khalid is the corresponding author. He will be in contact with whom ask for the data. His email is
abd.abd2302m@conursing.uobaghdad.edu.iq
What processes are involved for a request to access data/document
Users can ask for the data and the permission via email. Abdulrazaqz Abdulrahman Khalid is the corresponding author. He will be in contact with whom ask for the data. His email is
abd.abd2302m@conursing.uobaghdad.edu.iq