Comparative study of the effect of acupressure and ice bag on the pain during removal of femoral artery sheath in angioplasty patients admitted to Angiography ward
Comparison of pain mean during removal of femoral sheath in acupressure and ice bag groups among angioplasty patients admitted angiography part
Design
This study is a clinical trial in which patients are randomly divided into three groups of 30 members. For first group acupressure and for the second group ice bags was used. For third group, the control group, patients' hand will be taken. arterial sheath in all three groups is removed in similar condition.
Settings and conduct
This study is a randomized clinical trial that will be carried out in the angiography ward of Ali ebne Abitaleb hospital in Rafsanjan.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having Iranian nationality;
Being conscious;
Hemodynamically stable patients.
non entry criteria:
Patient who has emergency status and dangerous arrhythmia;
Administration of sedative and analgesic;
History of mental health problems;
History of using acupressure;
Previous angiography;
Drug and alcohol addiction.
Intervention groups
In the acupressure group, the IL4 point will be pressed for 20 minutes before the sheath is removed by the trained nurse. For the ice bag group, 15 minutes before the arterial sheath is removed, the ice bag will be placed at the 0 to 2 degrees Celsius in the place of the femoral artery sheath in the inguinal area. In the control group, 20 minutes before the femoral artery sheath is removed, a nurse will be asked to take the patient's hand and then sheath will be removed. In this study, the pain intensity will be determined in two steps (before and immediately after the arterial sheath removal) using VAS scale.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150519022320N15
Registration date:2018-11-02, 1397/08/11
Registration timing:registered_while_recruiting
Last update:2018-11-02, 1397/08/11
Update count:0
Registration date
2018-11-02, 1397/08/11
Registrant information
Name
Tayebeh Mirzaei
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.mirzaei@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-12, 1397/05/21
Expected recruitment end date
2018-11-12, 1397/08/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of acupressure and ice bag on the pain during removal of femoral artery sheath in angioplasty patients admitted to Angiography ward
Public title
The effect of acupressure and ice bag on the pain during removal artery sheath
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Iranian nationality
Being conscious
Hemodynamically stable patients
Exclusion criteria:
Patient who has emergency status and dangerous arrhythmia
Receiving sedative and analgesics
History of mental health problems
History of using acupressure
Previous angiography
Drug and alcohol addiction
History of mental and physical health problems, including vision, hearing, Parkinson's disease, multiple sclerosis
Cold sensation and Raynaud's disease
A particular problem at the site of acupressure (scars, burns, cysts, abscesses)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was Simple randomization using Random numbers table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
School of Nursing and Midwifery, Parastar Avenue
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Approval date
2018-06-23, 1397/04/02
Ethics committee reference number
IR.RUMS.REC.1397.066
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain relife
Timepoint
Before and immediately after removing artery sheath
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the acupressure group, the IL4 point, is pressed for 20 minutes before the sheath is removed by the trained nurse.
Category
Treatment - Other
2
Description
Intervention group: For the ice bag group, 15 minutes before the arterial sheath is removed, the ice bag at 0-2 degrees Celsius is placed at the femoral artery area (in the inguinal area).
Category
Treatment - Other
3
Description
Control group: In this group, The nurse is asked to take the patient's hand for 20 minutes before removing the arterial sheath.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-ibn Abitaleb Hospital, Department of Angiography, Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Ravary
Street address
Rafsanjan nursing faculty, Parastar street
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
ravary4776@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Ali Ravary
Street address
Rafsanjan University of Medical Sciences, Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3428 0038
Email
ravary4776@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr ravary Ali
Position
PhD, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
آدرس خیابان Faculty of Nursing, Nurse blv, Jomhury street, Rafsanjan
City
rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3425 5900
Email
ravary4776@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Ali Ravary
Position
PhD, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Parastar blvd, Jomhury street
City
Rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3425 5900
Email
ravary4776@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Ravary Ali
Position
PhD, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jomhoori Eslami BoLV,Street Nursery
City
rafsanjan
Province
Kerman
Postal code
7718174715
Phone
+98 34 3425 5900
Email
ravary4776@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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