The aim of this study was the effects of guided imagery on anxiety, depression, fatigue and hemodynamic parameters in patients undergoing hemodialysis. In this randomized clinical trial, 80 hemodialysis patients were randomly allocated to two groups guided imagery and control (40 patients in each group). The study will be conducted on hemodialysis patients admitted to Rajaee Hospital in Karaj. In intervention group, patients will listen CD of guided imagery for 20 minutes. Interference will not occur in the control group. Before the intervention, after intervention, 30 minutes after intervention, and at the end of hemodialysis anxiety, depression, fatigue, and hemodynamic parameters are measured and recorded. The researchers and data monitoring committee will not become aware of what sort of intervention the patients have been received
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512077529N9
Registration date:2015-12-20, 1394/09/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-20, 1394/09/29
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University Vice chancellor for research
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-03-10, 1394/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of guided imagery on hospital anxiety and depression and hemodynamic parameters in patients undergoing hemodialysis
Public title
Effect of guided imagery on the level of anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: the desire to participate in the study; the absence of cognitive impairment or impaired cognitive function of patients; not having hearing impairment; ability reading and writing; aged between 35 and 70 years, having high anxiety and depression scores of 7 tools HADS. Exclusion criteria: condition of hemodynamic is unstable; transfer of patient to another ward; patient dissatisfaction to continue participation in the study.
Age
From 35 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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 Shahed University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran.
City
Tehran
Postal code
Approval date
2015-11-16, 1394/08/25
Ethics committee reference number
Shahed.REC.1394.64
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
2
Description of health condition studied
anxiety
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention in first session and in final any sessions Before , after the intervention, 30 minutes after intervention, and after finish of the hemodialysis
Method of measurement
anxiety and depression scale (HADS)
2
Description
Depression
Timepoint
Before the intervention in first session and in final any sessions Before , after the intervention, 30 minutes after intervention, and after finish of the hemodialysis
Method of measurement
anxiety and depression scale (HADS)
3
Description
Fatigue
Timepoint
Before the intervention in first session and in final any sessions Before , after the intervention, 30 minutes after intervention, and after finish of the hemodialysis
Method of measurement
Brief Fatigue Inventory
4
Description
Blood pressure
Timepoint
Before the intervention in first session and in final any sessions Before , after the intervention, 30 minutes after intervention, and after finish of the hemodialysis
Method of measurement
Checklist
5
Description
Respiratory rate
Timepoint
Before the intervention in first session and in final any sessions Before , after the intervention, 30 minutes after intervention, and after finish of the hemodialysis
Method of measurement
Checklist
6
Description
Pulse rate
Timepoint
Before the intervention in first session and in final any sessions Before , after the intervention, 30 minutes after intervention, and after finish of the hemodialysis
Method of measurement
Checklist
7
Description
Oxygen saturation
Timepoint
Before the intervention in first session and in final any sessions Before , after the intervention, 30 minutes after intervention, and after finish of the hemodialysis
Method of measurement
pulse oximeter
8
Description
Mean blood pressure
Timepoint
Before the intervention in first session and in final any sessions Before , after the intervention, 30 minutes after intervention, and after finish of the hemodialysis
Method of measurement
Checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The researcher is sitting on the chair beside the patients. The patients will hearing to guided imagery CD for 20 minutes. Researcher is filling the scales consists: anxiety and depression scale (HADS), Brief Fatigue Inventory , and hemodynamic parameters before intervention, after intervention, 30 minutes after intervention and end of hemodialysis.
Category
Other
2
Description
Interference will not occur in the control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Martyr Rajai Hospital
Full name of responsible person
Yaser Beyzaie
Street address
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University Vice chancellor for research
Full name of responsible person
Dr. Zahra Kiasalari
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University Vice chancellor for research
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
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran .
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)