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The effectiveness of acceptance and commitment therapy (ACT) before dialysis, and exercises with mindfulness in dialysis time on hemodialysis patients in terms of dialysis adequacy, biological and psychological indicators.

Protocol summary

Study aim
determination of The effectiveness of acceptance and commitment therapy before dialysis, and exercises with mindfulness in dialysis time; on hemodialysis patients in terms of dialysis adequacy, biological and psychological indicators.
Design
The clinical trials with control group and two parallel intervention groups will be performed on 60 hemodialysis patients. Sampling was done randomly using Excel software
Settings and conduct
the present study will be conducted in presence of patients and education, with a questionnaire on patients at the Imam zaman hospital. After the pre - test, training sessions, mindfullness and sports exercises will be conducted. the experimental indices of patients will be measured and recorded before and after the intervention to investigate the changes and effectiveness of the therapeutic approach.
Participants/Inclusion and exclusion criteria
Inclusion criteria: effective AV fistula; the form of permission ; Physical ability through walking testing; Having a bachelor's degree of education; Age of patients up to 60 years; The history of dialysis for six months; Having a desire to participate in research Exclusion criteria: kidney transplant experience; chemotherapy or radiotherapy; No hospitalizing during intervention; diabetes and blood pressure; Lack of consciousness at places and time; Mental and physical disability and infection and leg wounds
Intervention groups
first group:ACT intervention is performed before the dialysis. The second group: training exercises with the mindfullness during their dialysis. Third group: control group that will not interfere with any intervention.
Main outcome variables
Dialysis efficacy; Psychological indices; Biological indices;

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200604047657N1
Registration date: 2020-07-22, 1399/05/01
Registration timing: prospective

Last update: 2020-07-22, 1399/05/01
Update count: 0
Registration date
2020-07-22, 1399/05/01
Registrant information
Name
Ali Kazemidaluee
Name of organization / entity
The University of Imamreza
Country
Iran (Islamic Republic of)
Phone
+98 51 3847 9808
Email address
alikazemidaluee1350@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-04, 1399/05/14
Expected recruitment end date
2020-08-09, 1399/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of acceptance and commitment therapy (ACT) before dialysis, and exercises with mindfulness in dialysis time on hemodialysis patients in terms of dialysis adequacy, biological and psychological indicators.
Public title
The effectiveness of psychological treatments and exercises on life efficacy and treatment of hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
having an effective arterial and venous fistula, completing the testimonial form, having a minimum diploma, minimum age of 60, doing hemodialysis for 6 months, having a desire to participate in research, lack of participation in other psychological periods.
Exclusion criteria:
The experience of kidney transplantation, chemotherapy or radiotherapy, no hospitalizing in interaction period, lung disease need to oxigen therapy, diabetes and blood pressure, lack of consciousness in place and time, mental and physical disability, infection, and leg wounds, are excluded from the group in the event of an illness in the exercise time.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The simple randomization method will be done , using the random numbers table and assigning each number to a patient.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of birjand university of medical sciences
Street address
Emam zaman hospital, sarakhs Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9175756422
Approval date
2020-06-23, 1399/04/03
Ethics committee reference number
IR.BUMS.REC.1399.116

Health conditions studied

1

Description of health condition studied
Chronic Renal Failure
ICD-10 code
I13.11
ICD-10 code description
Hypertensive heart and chronic kidney disease without heart failure, with stage 5 chronic kidney disease, or end stage renal disease

Primary outcomes

1

Description
Dialysis efficacy
Timepoint
Once a month from 15 August( since get the patient)
Method of measurement
Daugirdas index to assess the quality of dialysis

2

Description
depression
Timepoint
Once a month from 15 August( since get the patient)
Method of measurement
Doss scale of depression

3

Description
Avoidance
Timepoint
Once a month from 15 August( since get the patient)
Method of measurement
Avoidance questionnaire

4

Description
Disease Rumination
Timepoint
Once a month from 15 August( since get the patient)
Method of measurement
Multidimensional Rumination scale

5

Description
Disease Perception
Timepoint
Once a month from 15 August( since get the patient)
Method of measurement
Illness Perception Questionnaire

6

Description
Hope
Timepoint
Once a month from 15 August( since get the patient)
Method of measurement
Snyder Hope Scale

7

Description
Emotional efficacy
Timepoint
Once a month from 15 August( since get the patient)
Method of measurement
Emotion efficacy scale

8

Description
Global health
Timepoint
Once a month from 15 August( since get the patient)
Method of measurement
Health questionnaire

9

Description
Spiritual health
Timepoint
Once a month from 15 August( since get the patient)
Method of measurement
Spiritual well-being questionnaire

Secondary outcomes

1

Description
Biological index
Timepoint
Once a month from 15 August( get the patient)
Method of measurement
Monthly Routine Tests

Intervention groups

1

Description
Intervention group1: Effectiveness of ACT before dialysis: Training the ACTto dialysis patients and study the effect of this treatment model on mental health and dialysis efficacy in this patients.
Category
Treatment - Other

2

Description
Intervention group2 : Training exercises with mindfullness in dialysis period and study its effect on mental health and dialysis efficacy
Category
Treatment - Other

3

Description
Control group: There is no intervention in the group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam zaman hospital
Full name of responsible person
Mahmood khadem Al khamseh
Street address
Emam zaman hospital, sarakhs Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9175756422
Phone
+98 51 3365 2000
Email
alikazemidaluee1350@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. ali abadi
Street address
end of Ghafari Ave
City
Birjand
Province
South Khorasan
Postal code
9717813111
Phone
+98 56 3432 5502
Email
f.shahabizadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Emam reza university
Full name of responsible person
Ali kazemi daluee
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No0 327, jahanara7Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9175756422
Phone
0098 51 8479808
Email
alikazemidaluee1350@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Emam reza university
Full name of responsible person
Ali kazemi daluee
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No327, jahanara7Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9175756422
Phone
0098 51 8479808
Email
alikazemidaluee1350@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Emam reza university
Full name of responsible person
Ali kazemi daluee
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No327, jahanara7Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9175756422
Phone
0098 51 8479808
Email
alikazemidaluee1350@gmail.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
Yes - There is a plan to make this available
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
All of the statistical data of patients
When the data will become available and for how long
six months after publishing the evidences
To whom data/document is available
Professors, patients, treatmenr personals
Under which criteria data/document could be used
For increase the treatment efficacy
From where data/document is obtainable
www.aubir.ac.ir
What processes are involved for a request to access data/document
Asking from the azad university of birjand or visit the website of university
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