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The effect of acupressure on severity of muscle cramp pain in hemodialysis patients

Protocol summary

Study aim
Determine the effect of acupressure on the severity of muscle cramp pain in hemodialysis patients
Design
Participants will be divided into two groups of test and control by simple random assignment.In this way, the first person chooses one from the two envelopes containing the group determination paper, identified by numbers 1 and 2,and the next person in the other group will give the participants the difference between the pressure not explained
Settings and conduct
In both groups, pressure is applied to the pressure points (real, unrealistic) separately and bilaterally for 5 minutes at each point and 15 minutes before dialysis and twice a week during dialysis and twice a week. Participants, carers, planners, and analysts are considered blind.
Participants/Inclusion and exclusion criteria
1 Willingness to participate in the study2.having an education 3.staying in the age range of 18 to 80 4.no drug addiction5. lack of anatomical and dermatological problems at the relevant points6. Not having a history of acupressure 7. No known underlying mental illness 8. Patients undergo cramps at least once a week9. Patients undergo dialysis at least twice a week.10. The patient has not participated in any other treatment for at least the last 2 weeks.
Intervention groups
In the test group, the intervention consisted of pressing on each of the points, SP6, LI4, LI 11 individually and bilaterally for 5 minutes at each point and 15 minutes before dialysis and during dialysis twice a week for two weeks. ]n the control group (at the same rate and duration as the test group) at a 2 cm point in the main site, which is a false point, and It comes from acupuncture points.
Main outcome variables
Pain severity, muscle cramps

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190525043698N1
Registration date: 2019-10-23, 1398/08/01
Registration timing: retrospective

Last update: 2019-10-23, 1398/08/01
Update count: 0
Registration date
2019-10-23, 1398/08/01
Registrant information
Name
Amin Norozi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3757 6588
Email address
aminnorozi051@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on severity of muscle cramp pain in hemodialysis patients
Public title
The effect of acupressure on severity of muscle cramp pain in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The willingness to participate in the study Having literacy Stay in the age range of 18 to 80 No addiction Not having anatomical and dermatological problems at the relevant points. Not having a history of using acupressure Missing mental illness detected Patients develop cramps at least once a week Patients undergo dialysis at least twice a week. The patient has not been involved in any other treatment for at least 2 weeks
Exclusion criteria:
Not wanting to continue studying for any reason Any problems or instability during the intervention Drug addiction Having a known mental illness
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be divided into two groups of experimental (acupressure) and control (pseudo-pressure) with simple random assignment using a sealed envelope. The first person then selects one of the two envelopes containing the group designation paper numbered 1 and 2, and then the next one falls into the other group to tell the participants about the difference between Pressure in the control and test groups is not explained. They were assured that there was no known complication for acupuncture and that they would be notified if any problems arose, and that they could be excluded if they did not wish to, and this would have an impact on their care. Will not leave.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are blinded by the use of pressure on unrealistic points, statistical analysts by assigning code to questionnaires, designers by coding questionnaires, patient caregivers by applying pressure points to all patients
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of ُSabzevar University of Medical Sciences
Street address
Deputy of Education,University Campus Building,Above the Unknown Martyrs' Tomb,Tohid Boulevard,Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.MEDSAB.REC.1398.010

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
N03
ICD-10 code description
Chronic nephritic syndrome

Primary outcomes

1

Description
Pain severity: An unpleasant emotion and experience associated with actual or potential tissue damage.Practical Definition of Pain: A score obtained from a numerical pain scale
Timepoint
5 minutes before the intervention and then after the intervention
Method of measurement
visual Analogue Scale

2

Description
Muscle cramps: involuntary, sudden, prolonged, and usually painful contractions in one or more muscles, and may take from a few seconds to a quarter of an hour.
Timepoint
Before intervention start and end of intervention
Method of measurement
Patient self-report record

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention means pressing on each of the points, SP6, LI4, LI 11 individually and bilaterally for 5 minutes at each point and 15 minutes before dialysis and twice a week for two weeks and during dialysis. The correctness of the pressure is confirmed when the patient feels warm, heavy, swollen or numb at that point.
Category
Treatment - Other

2

Description
Control group: Pressure (equal to and equal to the test group) is applied at a 2 cm point in the main site, which is a false point and is not an acupressure point.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasei Hospital of Sabzevar
Full name of responsible person
Alemeh Dehnabi
Street address
Mohammad Vasiei Hospital,Tohid Shahr Boulevard, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4465 1300
Email
vasei.h@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Ghorat
Street address
Vice Chancellor for Research and Technolog,University of Medical Sciences Campus,Above Memorial of Unknown Martyrs, Boulevard of Nuclear Martyrs,Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8300
Fax
Email
vc.Research@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Amin Norozi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Plate 24,Yas 9,Abdulmutallab 15,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9199973846
Phone
+98 51 3757 6588
Email
aminnorozi051@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Alemeh Dehnabi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
First Floor,Next to the Marble Caravan,Facing the Revolution 19,El Ahmed Square
City
Sabzevar
Province
Razavi Khorasan
Postal code
9199973846
Phone
+98 51 4465 9348
Email
a.dehnabi95@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Amin Norozi
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 48,Yas9, Abdulmutallab 15
City
Mashhad
Province
Razavi Khorasan
Postal code
9199973846
Phone
+98 51 3757 6588
Email
aminnorozi051@gamil.com

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
Not applicable
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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
For researchers working only in academic and scientific institutions
Under which criteria data/document could be used
For use in scientific articles
From where data/document is obtainable
aminnorozi aminnorozi051@gmail.com
What processes are involved for a request to access data/document
By email and send it
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