Objectives: 1- To investigate the effect of meditation on hemodialysis adequacy among patients undergoing hemodialysis 2- To investigate the effect of meditation on some psychological complications of hemodialysis (Depression, anxiety, stress) among patients undergoing hemodialysis.
Design: This study was conducted as a clinical trial.
Setting and Conduct: All patients undergoing hemodialysis hospitalized in the two hospitals affiliated to Zanjan University of Medical Sciences including Emdadi hospital in Abhar and Boo Ali hospital in Khorramdarreh were recruited to the study based on the inclusion criteria. Using the table of random numbers we will allocate the patients to two intervention and control groups. Data will be measured using the Stress Anxiety Depression Scale-21 (DASS-21) and the dialysis adequacy scale.
Participants including major eligibility criteria: All 67 patients with hemodialysis hospitalized in the two hospitals affiliated to Zanjan University of Medical Sciences will be recruited to the study. The inclusion criteria include diagnosed with chronic kidney disease by their physicians; being under hemodialysis for at least three months; not having participated in other intervention studies; ability to participate in training sessions; ability to do meditation exercises; being registered in the hospital; lack of previous experiences with meditation; and lack of specific medical prohibitions, such as deafness, blindness, end-stage heart failure, brain trauma, uncontrolled hypertension and acute glaucoma; being consent to participate in the study; Lack of psychological drug use; lack of proved psychological disease. The exclusion criteria include unable or unwilling to participate in a group program; having reduced cognitive ability; hospitalized because of other medical conditions; having contraindications for doing meditation exercises; kidney transplantation during the study or referring to other hospitals; fistula or graft damages; and using psychological medications during the study.
Intervention: The intervention is the "Two Heart" meditation (meditation of love and kindness to all the land) program. The program comprises three 15- to 20-minutes educational practice sessions weekly offered over an eight-week period.
Main outcome measures(variables): Changes in depression, anxiety, and stress symptoms during the first two months will be considered.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102917454N3
Registration date:2014-12-07, 1393/09/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-07, 1393/09/16
Registrant information
Name
kourosh Amini
Name of organization / entity
Zanjan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 243377251314
Email address
korosh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zanjan University of Medical Sciences
Expected recruitment start date
2014-11-11, 1393/08/20
Expected recruitment end date
2015-02-09, 1393/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of meditation on hemodialysis adequacy and its psychological complications among patients undergoing hemodialysis
Public title
Effect of meditation on hemodialysis adequacy and some psychological symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria: diagnosed with chronic kidney disease by their physicians; being under hemodialysis for at least three months; not having participated in other intervention studies; ability to participate in training sessions; ability to do meditation exercises; being registered in the hospital; lack of previous experiences with meditation; and lack of specific medical prohibitions, such as deafness, blindness, end-stage heart failure, brain trauma, uncontrolled hypertension and acute glaucoma; being consent to participate in the study; Lack of psychological drug use; lack of proved psychological disease. The exclusion criteria include unable or unwilling to participate in a group program; having reduced cognitive ability; hospitalized because of other medical conditions; having contraindications for doing meditation exercises; kidney transplantation during the study or referring to other hospitals; fistula or graft damages; and using psychological medications during the study.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
67
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
Ethics Committee of the Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi Blvd., Zanjan, Iran
City
Zanjan
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
ZUMS.REC.1392.49
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
2
Description of health condition studied
Depression
ICD-10 code
F32.9
ICD-10 code description
Depressive episode, unspecified
3
Description of health condition studied
Stress
ICD-10 code
Z73.3
ICD-10 code description
Stress, not elsewhere classified
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention, four weeks after the intervention and after 8 weeks of intervention
Method of measurement
Depression, Anxiety, Stress Scale- 21 (DASS-21)
2
Description
Depression
Timepoint
Before the intervention, four weeks after the intervention and after 8 weeks of intervention
Method of measurement
Depression, Anxiety, Stress Scale- 21 (DASS-21)
3
Description
Stress
Timepoint
Before the intervention, four weeks after the intervention and after 8 weeks of intervention
Method of measurement
Depression, Anxiety, Stress Scale- 21 (DASS-21)
Secondary outcomes
empty
Intervention groups
1
Description
The program comprises three 15- to 20-minutes educational practice sessions weekly offered over an eight-week period. Half an hour before starting dialysis, patients will attend in a room located in the dialysis unit with the facilities including chair, enough space. The Two Hearts meditation exercises (meditation of love and kindness to all the land) will commence by a trained tutor to the intervention group. The duration of the meditation will last 15-20 minutes. The trained tutor will be available during the program.
Category
Behavior
2
Description
In order to decrease the investigator bias, the tutor and the researcher will attend the control group half an hour once a week and will discuss the dialysis and their related problems.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Emdadi hospital of Abhar city
Full name of responsible person
Sahar Dehgani
Street address
Emdadi hospital of Abhar, Khoramshar Boulevard, Abhar, Zanjan
City
Abhar
2
Recruitment center
Name of recruitment center
Bu-Ali hospital of Khoramdareh city
Full name of responsible person
Maryam Mohammadi
Street address
Bu-Ali hospital of Khoramdareh, Imam St, Khoramdareh, Zanjan
City
Khoramdareh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zanjan University of Medical Sciences
Full name of responsible person
Research administrator of university, Mohammad Masoud Vakili
Street address
Zanjan University of Medical Sciences, Azadi Blvd., Zanjan, Iran
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Kourosh Amini
Position
Assistant Professor/ PhD in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Zanjan University of Medical Sciences, Parvin Etesami Street, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24337751314
Fax
Email
korosh@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Kourosh Amini
Position
Assistant Professor/ PhD in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Zanjan Uinversity of Medical Sciences, Parvin Etesami Street, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 243377251314
Fax
Email
korosh@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Kourosh Amini
Position
Assistant Professor/PhD in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Zanjan Uinversity of Medical Sciences, Parvin Etesami Street, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24337751314
Fax
Email
korosh@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)