Determining the effect of foot reflexology massage on incidence and severity of pain due to muscle cramps in hemodialysis patients
Design
Clinical trials with control group and intervention group and randomized
Settings and conduct
After approving the research project and writing a written consent from the research vice chair and ethics committee of Islamic Azad University, Tehran Medical Branch, the researcher will go to the selected hospital and, by presenting the letter to the relevant center, will be allowed to enter the research environment, then by referring to the section Hemodialysis of Amir al-Momenin Hospital and Ayatollah Hospital of Esfahani Hospital, patients who have been admitted to the study are selected as samples.Patients' eyes in both groups will be evaluated on the intensity of pain and muscle cramps using a numerical scale of pain and a researcher-made questionnaire
Participants/Inclusion and exclusion criteria
Patients with a history of muscle cramp
Intervention groups
The intervention included reflexology massage for 3 weeks, three sessions per week for 15 minutes during hemodialysis on the intervention group.
The group carries out routine care by nurses in the hemodialysis department.
Main outcome variables
muscle cramp
General information
Reason for update
Acronym
Reflexology
IRCT registration information
IRCT registration number:IRCT20180717040503N1
Registration date:2018-10-17, 1397/07/25
Registration timing:retrospective
Last update:2018-10-17, 1397/07/25
Update count:0
Registration date
2018-10-17, 1397/07/25
Registrant information
Name
Tahereh Ashktorab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2266 0060
Email address
t.ashktorab@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology massage on incidence and severity of pain due to muscle cramp in hemodialysis patients
Public title
The effect of reflexology on muscular cramp hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People aged 18 to 60 years
Only feminine
History of at least 6 months of dialysis
Patients with a history of muscle cramp
Hemodialysis with sodium bicarbonate solution
Being on a hemodialysis weekly list and doing it 3 times a week and every 3 to 4 hours of hemodialysis
Do not link to the list when sampling
Non-infectious diseases-Arthritis-Rheumatoid arthritis
Not having open wound-burn-break-and deep-vein thrombosis
Failure to use anti-cramps or dermatologists
Exclusion criteria:
Not having muscle cramps
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Coupled days are randomly assigned to one of the groups and 35 patients are placed in each of the groups and receive the intervention of the same group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Research in Islamic Azad University, faculty of Medicin
Street address
Shariati Avenue., Khaghani Avenue . Islamic Azad University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2018-01-16, 1396/10/26
Ethics committee reference number
IR.IAU..TMU.REC.1396.255
Health conditions studied
1
Description of health condition studied
Muscle cramps in patients undergoing hemodialysis
ICD-10 code
Care invol
ICD-10 code description
Z49
Primary outcomes
1
Description
Reduced Severity pain due to muscle cramp
Timepoint
Before and after the intervention
Method of measurement
Numerical scale of pain
Secondary outcomes
1
Description
Reduce the frequency of muscle cramps
Timepoint
Before and after the intervention
Method of measurement
researcher‑made questionnaire
Intervention groups
1
Description
Intervention group: The intervention involves foot reflexology massage for 3 weeks,every week three sessions for 15 minutes during hemodialysis by the researcher after completing the course on the intervention group will be done .first, simple massage is given for 5 minutes to relaxing and relax the leg muscles. after relaxing reflexology massage points the research includes solar plexus , kidney, heart and brain given for 7 minutes.at the end again relaxing given for 3 minutes.
Category
Prevention
2
Description
The control group: received usual care by dialysis center staff.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir al-momenin hospital and Shahid ayatollah ashrafi esfahani
Full name of responsible person
Tahereh Ashk Torab
Street address
Shir Mohammadi Avenue, Opposite the Fores Park Commander,Nazi Abad
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6061
Email
ashrafihos@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research DeputyIslamic Azad University of Medical Sciences
Full name of responsible person
mozhgan ghasemi
Street address
Islamic Azad University of Medical Sciences, Tehran, Khaghani Avenue, Shariati Avenue
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
iautmu@iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research DeputyIslamic Azad 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
Islamic Azad University
Full name of responsible person
Ghasemi mozhgan
Position
M.A in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shariati St., Khaghani St.
City
Tehran
Province
Tehran
Postal code
193951495
Phone
+98 220066607
Fax
+98 21 2200 6660
Email
iautmu@iautmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Medical Sciences
Full name of responsible person
ashketorab tahereh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shariati St., Khaghani St.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 22006660
Email
iautmu@iautmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ashk torab tahereh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Tehran Medical Sciencest,Khaghani Avenue, Shariati Avenue
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Fax
+98 21 2200 6660
Email
iautmu@iautmu.ac.ir
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