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The comparetive effect of massage and dry cupping on dysrhythmia among patients admitted to cardiac care units of hospitals affiliated to Kerman University of Medical Sciences in 2018

Protocol summary

Study aim
The comparetive effect of massage and dry cupping ondysrhythmia among patients admitted to cardiac care units of hospitals affiliated to Kerman University of Medical Sciences in 2018
Design
Clinical trial with control group, with parallel groups, randomized
Settings and conduct
Study is done in cardiac care units of hospitals affiliated to Kerman University of Medical Sciences.In the control group,only the usual care of the cardiac care unit is provided.In the massage group,samples in addition to receiving usual care, From the second night of admission At the hospital,they will receive head and face massage for three nights .In the dry cupping group, samples in addition to receiving usual care,From the second night of admission At the hospital,they will receive dry cupping between the C3 and T4 vertebra, for three nights.
Participants/Inclusion and exclusion criteria
1)Ages 18 to 75 years 2) Patients with coagulation disorder diagnosed with a doctor 3) Severe vascular disease 4) Patients with intubates or with central vascular cats such as cvline and shaldon
Intervention groups
In the control group,only the usual care of the cardiac care unit is provided.In the massage group,samples in addition to receiving usual care, From the second night of admission At the hospital,they will receive head and face massage for three nights .In the dry cupping group, samples in addition to receiving usual care,From the second night of admission At the hospital,they will receive hot dry cupping between the C3 and T4 vertebra, for three nights.
Main outcome variables
The effect of massage and dry cupping on the dysrhythmia is compared

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190325043108N1
Registration date: 2019-08-05, 1398/05/14
Registration timing: registered_while_recruiting

Last update: 2019-08-05, 1398/05/14
Update count: 0
Registration date
2019-08-05, 1398/05/14
Registrant information
Name
Yaser Hamzehnejadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3325 5441
Email address
y.hamzehnejadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparetive effect of massage and dry cupping on dysrhythmia among patients admitted to cardiac care units of hospitals affiliated to Kerman University of Medical Sciences in 2018
Public title
Comparison of the effect of massage and dry cupping on dysrhythmia in cardiac patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 75 years All adult patients admitted to cardiac care unit
Exclusion criteria:
Patients with coagulation disorder diagnosed with a doctor Over-obesity with doctor's diagnosis severe vascular disease Open wound on the surface of the dry cupping Blend dry cupping with drug treatment with your doctor's opinion Pregnant women with gestational age of more than 4 months The presence of a tumor at the site of the intervention Patients with bone fracture at the site of the intervention Disease-like skin disease, such as sorezia Patients have intubates or have central vascular katers such as cvline and shaldon
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Block random assignment Samples (75 people) will select by convenience sampling method .Then randomly will be allocated blocks into three groups;2 intervention groups (25 massage , 25 dry cupping) and 25 in the control group. In this method, random block allocation will perform by the software.
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 Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.KMU.REC.1398.150

Health conditions studied

1

Description of health condition studied
Dysrhythmia
ICD-10 code
I49.9
ICD-10 code description
Cardiac arrhythmia, unspecified

Primary outcomes

1

Description
Prevalence of dysrhythmia
Timepoint
the nightFirst, second, third and fourth admissions
Method of measurement
Electrocardiogram

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First intervention group:In this group, in addition to receiving usual care, the massage was performed with 2 cc sweet almond oil (100% purity from Barij Kashan Essential Oil Company) for 15 minutes on the second night, once in They receive nightly nights for three nights. In this study, Brown Massage Therapy is used, which is a combination of Effleurage and pressure massage. To massage after resting the patient and draping the curtains at the patient's bed, the patient is placed in a half-sitting position, while the head of the bed is 45 degrees, then the masseur is placed above the patient's head and the massage stages It done
Category
Prevention

2

Description
Intervention group: Second intervention group:In this group, in addition to receiving usual care, the Contributors receive a dry cupping between the third neck and the fourth thoracic vertebrae from the second day of admission once a day for three days using a hand dry cupping.
Category
Prevention

3

Description
Control group: In the control group, only the usual care of the cardiac care unit is provided. To control dysrhythmia, the necessary therapeutic measures or, if necessary, measures such as the use of electrical shock, the removal of the arrhythmic arrhythmias and the insertion of a temporary or permanent pacemaker
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Mahmoud Nekoyi Moghaddam
Street address
shafa Medical Education Center, Kowsar Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
shafahospital@kmu.ac.ir

2

Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Ali Asghar Vahidi
Street address
Afzalipour Medical Education Center,next to Shahid Bahonar University, Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8000
Email
avahidi@kmu.ac.ir

3

Recruitment center
Name of recruitment center
Shahid Bahonar hospital
Full name of responsible person
Mahdi ahmadinejad
Street address
Shahid bahonar hospital, Qarani street, Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
Ahmadinejadmahdi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhty
Street address
Research and Technology Dept, Ibn Sina Ave, Somayeh Road (Tahmasebabad), kerman
City
Kerman
Province
Kerman
Postal code
7815789957
Phone
+98 34 3226 3855
Email
Vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Yaser Hamzehnejadi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
y.hamzehnejadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahlegha Dehghan
Position
Assistant Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
m_dehghan86@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Yaser Hamzehnejadi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3325 5441
Email
y.hamzehnejadi@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
No - There is not 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
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