Protocol summary

Study aim
Determining the Effect of Mindfulness Education on Life expectancy in hemodialysis patients
Design
A clinical trial with a control group in the waiting list and one month follow up of the intervention and control group
Settings and conduct
After sampling and assigning 45 patients in each intervention and control group, the study was conducted as Mental awareness training in 8 sessions of 90 minutes for the intervention group at Imam Hossein Hospital in Shahid Beheshti Hospital in Babol. At this time, no intervention was performed for the control group Failed. The training was done by a psychologist and with the help of a psychologist, as well as providing a manual for each patient. The intervention group was re-tested one month after the training (with follow-up by the researcher for exercises within a month). The questionnaires used in this study were Omid Schneider's questionnaire, Spielberg's anxiety, and Philips social suppo
Participants/Inclusion and exclusion criteria
Inclusion criteria 1-a willingness to participate in the study2-Being treated with dialysis3-Age up to age 65-184-History of at least three months hemodialysis5-Lack of well-known psychological illness, psychosis, stroke- ،Exclusion criteria Include 1-Mental disorders require immediate treatment2- Anxiety treatment with an officer3- Use of psychotics4-Late or absent in three sessions of training sessions5-No adherence to the assignment related to training intervention
Intervention groups
A total of 45 hemodialysis patients undergoing training on Mindfulness in 8 sessions of 90 minutes.The control group had 45 hemodialysis patients who did not receive any training.
Main outcome variables
Age, sex, anxiety, social support, duration of hemodialysis, underlying illness, mindfulness,Hope for life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171203037723N3
Registration date: 2019-01-23, 1397/11/03
Registration timing: retrospective

Last update: 2019-01-23, 1397/11/03
Update count: 0
Registration date
2019-01-23, 1397/11/03
Registrant information
Name
Hamideh Azimi Lolaty
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7343
Email address
azimihamideh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-17, 1397/01/28
Expected recruitment end date
2018-04-23, 1397/02/03
Actual recruitment start date
2018-06-28, 1397/04/07
Actual recruitment end date
2018-07-01, 1397/04/10
Trial completion date
2018-10-02, 1397/07/10
Scientific title
Learning Effects Mindfulness Knowledge on Life Expectancy in Dialysis Patients
Public title
Train the minds of patients with dialysis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Includes a willingness to participate in the study Being treated with dialysis Age up to age 65-18 Lack of well-known psychological illness, psychosis, stroke History of hemodialysis at least three months
Exclusion criteria:
Psychological disorders require immediate treatment Treated with anti-anxiety and anti-depressant drugs Use of psychotics Delay or absence in three sessions of training sessions A lack of adherence to the assignments related to training intervention
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Actual sample size reached: 90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
First, according to the criteria of entry from 2 hospitals, eligible patients were enrolled in the study, and according to the draw, one of the hospitals in the intervention group (45) and one in control group (45) were selected and then intervention was performed

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
IR.MAZUMS..REC.1397.159
Street address
Sari Street Teacher, Student Research Deputy
City
Sari
Province
Mazandaran
Postal code
48157-33971
Approval date
2018-06-25, 1397/04/04
Ethics committee reference number
IR.MAZUMS.REC.1397.159

Health conditions studied

1

Description of health condition studied
hemodialsis
ICD-10 code
I13.2
ICD-10 code description
Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease, or end stage renal disease

Primary outcomes

1

Description
Life expectancy
Timepoint
Measurement ofLife expectancy after 8 sessions of mindfulness intervention
Method of measurement
Schneider's Life Expectancy Questionnaire

Secondary outcomes

1

Description
Anxiety - Social Support
Timepoint
Before and after 8 sessions of mindfulness intervention
Method of measurement
Philip Social Support Questionnaire - Spielberg's Anxiety Inventory

Intervention groups

1

Description
Intervention Row: Intervention will be provided in 8 sessions of 90 minutes. There is also a booklet prepared on the basis of these sources and has been reviewed by psychiatrist, psychiatric nurse and doctorate in clinical psychology and has undergone and is subject to corrections. Available to each patient in the intervention group. Mental awareness training was carried out by a student and clinical education psychologist. Familiarity with the technique of teaching attention, familiarity with the technique of automatic guidance, familiarity with the training of tone, familiarity with the technique of respiratory mediation, familiarity with the examination technique of the body.
Category
Other

2

Description
Control group: Control group: Includes people with homo-dialysis disease that there is no intervention in them.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Feraidonkenar Imam Khomeini hemodylysis Center- Babol Shahid Beheshti Hospital
Full name of responsible person
Hamideh Azimi lolaty
Street address
nursing and midwifery faculth. vesale Shirazi
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7343
Fax
+98 11 3336 8915
Email
azimihamideh@gamil.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saiedi
Street address
Resarch Dupty , Moalem square , Talghni Boulvar
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Fax
+98 11 3326 1244
Email
SRC@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
50
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
Mazandaran University of Medical Sciences
Full name of responsible person
Hamideh Azimi lolaty
Position
ssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatric nursing
Street address
Nasibeh nursing & midwifery faculty, vesale shirazi street , amir mazandarani boulvar .
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Email
azimihamideh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamideh Azimi lolaty
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
psychiatric nursing
Street address
- Nasciba Faculty of Nursing and Midwifery - Vesal Street- - Amir Mazandrani Blvd -
City
sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7343
Email
-midnasibeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
hamideh azimi lalouti
Position
Director of Nursing Department
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Mazandaran - Sari - Amir Mazandrani Blvd - Vesal Street - Nasciba Faculty of Nursing and Midwifery
City
sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 33374750
Email
midnasibeh@yahoo.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
No - There is not 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
Loading...