Determining the effect of light therapy on the outcomes of dialysis patients such as pain, itching and inflammation
Design
A Clinical trial With a Control Group, With Parallel Groups, Non-blind,Non randomized, on 66 Patients.
Settings and conduct
This study is conducted on hemodialysis patients in the dialysis department of Baqiyatullah Hospital in Tehran. 66 patients are selected and divided into two groups of 33 people, control and intervention. The questionnaire related to each of the dependent variables is provided to the patients and the venous CRP of all patients is determined. When the patient is undergoing hemodialysis, for four weeks, three times a week, with a duration of ten minutes, light therapy with the Bioptron device is performed for each patient in the intervention group. In this way, using a portable Biopteron device for ten minutes and from a distance of 10-15 cm on the The carotid area of the patients is illuminated. After the end of the intervention, the questionnaires are answered again by the patients and the CRP level of the patients is also checked.
Participants/Inclusion and exclusion criteria
Entry conditions include: over 18 years of age and not suffering from skin infections and having 6 months of dialysis experience
Intervention groups
In the intervention group, we intend to perform light therapy using the waves of the Biopteron light therapy device on the neck area of hemodialysis patients. The duration of the intervention is 12 sessions and three times a week for 10 minutes. After the intervention, the amount of its effect on inflammation Itching and pain of dialysis patients are measured and compared with the control group.
Main outcome variables
Reducing The amount of inflammation، itching and Pain in Hemodialysis Patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230925059505N1
Registration date:2024-04-29, 1403/02/10
Registration timing:retrospective
Last update:2024-04-29, 1403/02/10
Update count:0
Registration date
2024-04-29, 1403/02/10
Registrant information
Name
Milad Moradipouya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 7670
Email address
mmpooya1993@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-12, 1403/01/24
Expected recruitment end date
2024-04-18, 1403/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: Evaluating the Effect of Light Therapy on Consequences in Dialysis Patients
Public title
the Effect of Light Therapy on Consequences in Dialysis Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All hemodialysis patients who have been treated with hemodialysis for 6 months
Exclusion criteria:
Having mental illnesses
Infectious skin diseases
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Baqiyatullah University of Medical Sciences
Intervention group: In the intervention group, light therapy is performed for 12 sessions and each session lasts 10 minutes using Bioptron light therapy device in the neck area of dialysis patients during hemodialysis.
Category
Other
2
Description
Control group: They do not undergo any treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
baqiatallah hospital
Full name of responsible person
Ali Tayebi
Street address
Sheykh Bahaee Street., Molasadra Street
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 7676
Email
Mmpooya1993@Gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. ّ Fakhruddin Feyzee
Street address
Sheykh Bahaee Street ., Molasadra Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8126 7671
Email
Mmpooya1993@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Milad Moradipouya
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
No31.Mehrabi.Mohamadian.eryanak
City
Tehran
Province
Tehran
Postal code
1355665688
Phone
+98 21 8126 7670
Fax
Email
Mmpooya1993@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Milad Moradipouya
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
No31.Mehrabi.Mohamadian.Beryanak
City
Tehran
Province
Tehran
Postal code
1355665688
Phone
+98 21 8126 7670
Fax
Email
Mmpooya1993@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Milad Moradipouya
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
No31.Mehrabi.Mohamadian.Beryanak
City
Tehran
Province
Tehran
Postal code
1355665688
Phone
+98 21 8126 7670
Fax
Email
Mmpooya1993@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
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