The present study aimed to investigate the effect of mindfulness program on general health among patients treated with hemodialysis.This research was a clinical trial which selected 60 patients treated with hemodialysis who were eligible for the study and determined the level of their general health. These patients were divided into two experimental and control groups. The experimental group received 8 training sessions of mindfulness skills while the control group received 8 training sessions associated with end-stage renal failure and hemodialysis without being exposed to any mindfulness concept. Training sessions for both groups were carried out in the second 30 minutes after initiation of dialysis in six 1-hour individual sessions and two 1.5-hour plenary sessions.
The mean score of general health and its subscales (physical symptoms, anxiety symptoms and sleep disturbances, social dysfunction and depression symptoms) were compared in each group and between the two groups before, immediately after and one month after the intervention. Data collection tool was General Health Questionnaire (GHQ). Data analysis was performed using SPSS v. 20, chi-square test, repeated measures ANOVA and independent t-test.
General information
Acronym
Mindfulness
IRCT registration information
IRCT registration number:IRCT2017053134263N1
Registration date:2017-06-15, 1396/03/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-15, 1396/03/25
Registrant information
Name
Maryam Mosavinejad Naeini
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3786 1027
Email address
m.moosavi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2017-01-09, 1395/10/20
Expected recruitment end date
2017-01-24, 1395/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness program on general health of patients treated with hemodialysis in Isfahan selected hospitals in 2017
Public title
The effect of mindfulness on general health in patients treated with hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Patients age are between 18 to 65; Hemodialysis onset 3 months at least; Hemodialysis do 3 times a week;They shouldn’t participate in any complementary treatments during this study; Over the past year, according to medical records, do not diagnose depression or other mental illness for them;They shouldn’t be treated with Psychiatry and Psychotherapy;They don’t have any intellectual or physical disability;Having full consciousness, acceptable hearing and speaking ability to answer the questions Exclusion criteria:Absent in two or more hope therapy sessions during study;Patients who giving kidney graft or going under peritoneal dialisys;Patients who don’t like to participate in every level of study;Patients start taking drugs to control depression, anxiety and stress in order of physician;Death
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:
60
Randomization (investigator's opinion)
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
Isfahan University of Medical Sciences
Street address
Hezarjirib street, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
11/4864/د
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis
Primary outcomes
1
Description
Physical symptoms
Timepoint
Before, after and 1 month after intervention
Method of measurement
GHQ-28
2
Description
Anxiety symptoms and sleep disturbances
Timepoint
Before, after and 1 month after intervention
Method of measurement
GHQ-28
3
Description
Social dysfunction
Timepoint
Before, after and 1 month after intervention
Method of measurement
GHQ-28
4
Description
Depression symptoms
Timepoint
Before, after and 1 month after intervention
Method of measurement
GHQ-28
5
Description
General health
Timepoint
Before, after and 1 month after intervention
Method of measurement
GHQ-28
Secondary outcomes
1
Description
The effect of mindfulness program on the general health
Timepoint
Before, after and 1 month after intervention
Method of measurement
GHQ-28
Intervention groups
1
Description
The experimental group received 8 training sessions of mindfulness skills.Training sessions were carried out in the second 30 minutes after initiation of dialysis in six 1-hour individual sessions and two 1.5-hour plenary sessions.
Category
Behavior
2
Description
The control group received 8 training sessions associated with end-stage renal failure diseases and hemodialysis without being exposed to any mindfulness concept.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor and Aliasghar Hospital
Full name of responsible person
Fariba Taleghani
Street address
Isfahan University of Medical Sciences
City
Isfahan
2
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Fariba Taleghani
Street address
Isfahan University of Medical Sciences
City
Isfahan
3
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Fariba Taleghani
Street address
Isfahan University of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fariba Taleghani
Street address
Hezarjirib street, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Maryam Moosavinejad Naeini
Position
MSc in Nursing Education
Other areas of specialty/work
Street address
Hezarjirib street, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3786 1027
Fax
Email
m.moosavi@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
College of Nursing and Midwifery, Isfahan University of Medical Sciences
Full name of responsible person
Nahid Shahgholian
Position
MSc
Other areas of specialty/work
Street address
Hezarjirib street, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 7539
Fax
Email
shahgholian@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences,College of Nursing and Midwifery
Full name of responsible person
Nahid Shahgholian
Position
MSc
Other areas of specialty/work
Street address
Hezarjirib street, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 7539
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)