The effect of topical application of Rosemary essential oil on the severity of inflammation and pain induced by needle insertion into arterial venous fistula in patients undergoing chronic hemodialysis
The effect of topical application of rosemary essence on the severity of pain and inflammation caused by needle insertion into venous arterial fistula in hemodialysis patients
Design
The present study is a randomized controlled clinical trial on hemodialysis patients in hemodialysis ward of Golestan and Imam Khomeini Hospitals in Ahvaz, Iran.The present study will be propounded with the University Ethics Committee and then it will be started with permission from the Honorable Research Assistant. sample size according to the previous results of studies and the sample size formula is considered 60 people that will be divided into control and intervention groups by using block design.
Settings and conduct
The present study is a randomized controlled clinical trial on hemodialysis patients in hemodialysis ward of Golestan and Imam Khomeini Hospitals in Ahvaz, Iran. Sixty patients undergo hemodialysis in Golestan and Imam Khomeini Hospitals of Ahvaz in two groups of intervention and control. The severity of pain during pinching and inflammation of the fistula is measured in both control and intervention groups.3 Puff of rosemary essential oil 5 minutes before surgery Hitting is used. After 5 minutes, the needle is disinfected and the needle is inserted. The placebo group uses 3 puff water spray
Participants/Inclusion and exclusion criteria
Age over 18 years,
Perform three dialysis sessions per week,
6 months after fistula fixation
Intervention groups
At the time of the intervention,3 puffs of rosemary essential oil will be applied 5 minutes before hemodialysis at the injection site. After 5 minutes, the injection site will be disinfected with alcohol and the needle will be inserted.in placebo group will be used 3 puff of water spray.
Main outcome variables
The severity of pain and inflammation caused by needle entry into the venous arterial fistula
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191028045263N1
Registration date:2020-01-06, 1398/10/16
Registration timing:retrospective
Last update:2020-01-06, 1398/10/16
Update count:0
Registration date
2020-01-06, 1398/10/16
Registrant information
Name
roya maramazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 8993
Email address
roya0939590@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-21, 1398/08/30
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical application of Rosemary essential oil on the severity of inflammation and pain induced by needle insertion into arterial venous fistula in patients undergoing chronic hemodialysis
Public title
The Effect of Rosemary Essential Oil on Severity of Inflammation and Pain Due to Needle Entry to Intravenous Arterial Fistula in Hemodialysis Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having Intravenous artery fistula
Six month after fistula fixation
Having three dialysis sessions in a week
Randomized block design will be assigned to two intervention and control groups. Four blocks will be used in this study and the numbers will be assigned to them according to the following list (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)) Then select random numbers from one to 6 (eg 1 4 5 and ...) and randomization will continue until the last participant.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahwaz University of Medical Sciences
Street address
No.51,fifteen Ave.,kianpars Blvd.,Ahwaz Town
City
Ahwaz
Province
Khouzestan
Postal code
6155873687
Approval date
2019-10-25, 1398/08/03
Ethics committee reference number
IR.AJUMS.REC.1398.545
Health conditions studied
1
Description of health condition studied
Severity of pain and inflammation induced by needle insertion into venous arterial fistula in patients undergoing chronic hemodialysis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
severity of pain induced by needle insertion into arterial venous fistula
Timepoint
Before intervention and during next six sessions of dialysis
Method of measurement
Iran phlebitis checklist and Visual Analogue Scale
2
Description
severity of inflammation induced by needle insertion into arterial venous fistula
Timepoint
Before intervention and during next six sessions of dialysis
Method of measurement
Iran phlebitis checklist and Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The researcher will use 3 puffs of rosemary essential oil 5 minutes before hemodialysis at the time of intervention. After 5 minutes, the injection site will be disinfected with alcohol and the needle will be inserted. To control for confounding factors, the entire process of needle placement in the fistula will be performed by four nurses with at least six months of dialysis and researcher supervision. The type of needle will be the same in size, shape and manufacturer. Also, the needle will be placed in the fistula for all specimens with a 20-30 degree angle. The intervention will last for six sessions
Category
Other
2
Description
Control group: In the control group water spray is used, three puffs are sprayed at the needle insertion place for six intermittent sessions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Leili Khashen
Street address
No.51,fifteen Ave.,kianpars Blvd.,Ahwaz Town
City
Ahwaz
Province
Khouzestan
Postal code
6155873687
Phone
+98 61 3391 8993
Email
roya0939590@gmail.com
2
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Minoo Baratifar
Street address
No.51,fifteen Ave.,kianpars Blvd.,Ahwaz Town
City
Ahwaz
Province
Khouzestan
Postal code
6155873687
Phone
+98 61 3391 8993
Email
roya0939590@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marziyeh Asadi Zaker
Street address
Golestan,Ahvaz University of Medical Sciences
City
Ahwaz
Province
Khouzestan
Postal code
6155873687
Phone
+98 61 3391 8993
Email
roya0939590@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahvaz University of Medical Sciences
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
Ahvaz University of Medical Sciences
Full name of responsible person
Roya Maramazi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.51,fifteen Ave.,kianpars Blvd.,Ahwaz Town
City
Ahwaz
Province
Khouzestan
Postal code
6155873687
Phone
+98 61 3391 8993
Email
roya0939590@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Roya Maramazi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kianpars,15 st.
City
Ahvaz
Province
Khouzestan
Postal code
6155873687
Phone
+98 61 3391 8993
Fax
Email
roya0939590@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Roya Maramazi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kianpars,15 st.
City
Ahvaz
Province
Khouzestan
Postal code
6155873687
Phone
+98 61 3391 8993
Fax
Email
roya0939590@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available