The aim of this study will be to determine the effect of Guided imagery compared with routine care on anxiety and quality of sleep among hemodialysis Patients. Some items of inclusion criteria included: patients at the age of 18 to 70 years; having full consciousness and Hemodialysis history for at least 2 months. Also, some exclusion criteria included: if the patients suffer from Severe physical disease or unable to collaborate.
In this randomized clinical trial, 70 patients undergoing hemodialysis in Akhavan Hospital at Kashan city will be assigned into intervention and control groups through block randomization in 2017. After initial selection of samples, demographic data form and STAI anxiety and PSQI quality of sleep questionnaire will be completed in both groups. In the intervention group, in addition to the routine care, guided visualization CD which will be prepared by the researcher and last about 25 minutes, will be played and patients listen to them through headphones. Guided visualization includes visualization of the beautiful and pleasant scenery (the beach) and positive inspiration which is associated with increased wellness. Intervention group will receive mentioned interventions 2 times a day, in the morning (between 8 and 9 am) and at night (between 20 and 21 pm), for 4 weeks. The control group will receive routine care. Four weeks after the end of the intervention, STAI anxiety and PSQI quality of sleep questionnaire will be completed again for both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120931312N1
Registration date:2017-01-06, 1395/10/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-06, 1395/10/17
Registrant information
Name
Abbas Mohsenzadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
mohsenzadeh-a@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-01-07, 1395/10/18
Expected recruitment end date
2017-03-15, 1395/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of guided imagery and routine care on Anxiety and Quality of sleep among hemodialysis patients
Public title
The Effect of Guided imagery on Anxiety and Quality of sleep of Hemodialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients at the age of 18 to 70 years old; having full consciousness; not having hearing loss; Patients' willingness to participate in clinical trials; Hemodialysis history for at least 2 months; absence of opium addiction history; not participation in guided imagery sessions in the past.
Exclusion criteria: suffer from a severe physical disease; hospitalization and undergoing surgery; not willing to participate in the study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The method of choice for randomization in this study is block randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, 5th kilometer of Qotb –e Ravandi Blvd, Kashan Kashan
City
Kashan
Postal code
87135/1416
Approval date
2016-11-08, 1395/08/18
Ethics committee reference number
IR.KAUMS.REC.1395.80
Health conditions studied
1
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 and 4 week after the intervention
Method of measurement
STAI Anxiety questionnaire
2
Description
quality of sleep
Timepoint
before the intervention and 4 week after the intervention
Method of measurement
PSQI quality of sleep questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: intervention group will listen to the Guided Imagery CD which is prepared by the researcher by using a CD player and headphones for 25 minutes, 2 times a day in the morning (between 8 and 9 am) and at night (between 20 and 21 pm) for 4 weeks, in addition to routine care.
Category
Other
2
Description
Control group: they will receive only routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhavan hospital
Full name of responsible person
Mohammad Afshar
Street address
Akhavan hospital, in front of Municipality, Abazar Avenue, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Kashan University of Medical Sciences, 5th kilometer of Qotb –e Ravandi Blvd, Kashan Kashan
City
kashan
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, Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Afshar
Position
PhD/ assistance professor
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, 5th kilometer of Qotb –e Ravandi Blvd, Kashan Kashan