The present study will be conducted at "Hami Dialysis Center" in Arak, and on hemodialysis patients. The samples and the data analyzer will not know how to place the samples in the intervention and control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: nausea and vomiting due to hemodialysis; conduct at least two dialysis sessions per week; have at least 3 months of dialysis history; 18-65 years old; no use of other complementary therapies during the study. Exclusion criteria: unwillingness to participate in the study; acute infection in the foot; stroke with sensory-motor problems.
Intervention groups
After receiving permission from the patient and explaining the procedure, foot reflexology massage will be performed for the intervention group and for the control group, massage will be performed on the shin of legs.
Main outcome variables
Nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161210031328N7
Registration date:2018-02-11, 1396/11/22
Registration timing:registered_while_recruiting
Last update:2018-02-11, 1396/11/22
Update count:0
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
Mahbobeh Sajadi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3402 0115
Email address
m.sajadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research of Arak University of Medical Sciences
Expected recruitment start date
2018-02-09, 1396/11/20
Expected recruitment end date
2018-04-09, 1397/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of reflexology on nausea and vomiting of hemodialysis patients
Public title
The effect of reflexology on nausea and vomiting of hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Nausea and vomiting due to hemodialysis
Willingness to collaborate in the study
Conduct at least two hemodialysis sessions per week
Have at least 3 months of hemodialysis history
Absence of skin disease with leg involvement
Lack of coagulation disorders
Age between 18 to 65 years old
Non-use of other complementary therapies during the study
Exclusion criteria:
The patient's unwillingness to collaborate in the study
Acute infection or ulcer in the leg
Stroke and sensory-motor problems in the leg
Age
From 17 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are divided into intervention and control groups using randomized block allocation method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Samples and researcher will not know how to allocate to the intervention and control group.
Placebo
Not used
Assignment
Parallel
Other design features
Samples were randomly assigned to two intervention and control groups using randomized block allocation method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alam al hoda St, Rah ahan Sq
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2018-01-14, 1396/10/24
Ethics committee reference number
IR.ARAKMU.REC.1396.242
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
Nausea and
ICD-10 code description
R11
Primary outcomes
1
Description
Nausea due to hemodialysis
Timepoint
Daily and after intervention
Method of measurement
Using the VAS tool (Visual Analog Scale)
2
Description
Vomiting due to hemodialysis
Timepoint
Daily and after intervention
Method of measurement
Counting the number of vomiting
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: An intervention 1-2 hours after the onset of hemodialysis in the area of nausea and vomiting is done three days a week, for 4 weeks, 12 sessions and 30 minutes each time.
Category
Treatment - Other
2
Description
Control group: Massage is done an unrelated point with nausea and vomiting (legs).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak dialysis center of Hami
Full name of responsible person
Hossein Sarmadian
Street address
Sadi St, Ferdosi St, Ab Sq, Gerdou St
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 3100
Email
darman@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Vice Chancellor for research, Piambar Azam university complex, sardasht region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
Rsearch@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Vahid Naseri Salahshour
Position
MSc Student of Nursing in Medical Surgical Field
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Piambar Azam university complex, Basij Sq, Sardasht region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86341735057
Fax
Email
vahidnaseri1994@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Piambar Azam university complex, Basij Sq, Sardasht region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86341735057
Fax
Email
sajadimahbobeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Piambar Azam university complex, Basij Sq, Sardasht region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86341735057
Fax
Email
sajadimahbobeh@yahoo.com
Web page address
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information on the main outcome and the demographic information, can be shared after unidentifiable of people.
When the data will become available and for how long
The beginning of the access period is 18 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In order to utilize scientific purposes and mention the source used.
From where data/document is obtainable
Dr Mahboubeh Sajjadi, Ph.D. of Nursing, Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.
E-mail address: sajadimahbobeh@yahoo.com
What processes are involved for a request to access data/document
After receiving the email from the requester, the information will be sent within 2 to 3 business days.