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 cancer patients
Design
Two arm parallel randomized controlled trial
Settings and conduct
70 Eligible patients with cancer who were referred to the chemotherapy department of Shahid Beheshti Hospitals affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected in the study. 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 week at night (between 20 and 21 pm) for 4 weeks, in addition to routine care.
Participants/Inclusion and exclusion criteria
Some items of inclusion criteria included: patients at the age of 18 to 70 years; having full consciousness and Not having hearing loss . Also, some exclusion criteria included: if the patients suffer from Severe physical disease or unable to collaborate.
Intervention groups
cancer patients will be assigned into intervention and control groups through Simple randomization method
Main outcome variables
The State-Trait Anxiety Inventory and Pittsburgh Sleep Quality Index will be quantified at study baseline, end-of-trial and 4 weeks after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180707040374N1
Registration date:2018-08-27, 1397/06/05
Registration timing:prospective
Last update:2018-08-27, 1397/06/05
Update count:0
Registration date
2018-08-27, 1397/06/05
Registrant information
Name
mohammad afshar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
afshar_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-28, 1397/06/06
Expected recruitment end date
2018-09-28, 1397/07/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of guided imagery on anxiety and quality of sleep in cancer patients
Public title
The effect of guided imagery on anxiety and quality of sleep in cancer patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients' willingness to participate in clinical trials
Patients at the age of 18 to 70 years old
Having full consciousness
Diagnosis of cancer by a specialist within the last 6 months
Not having hearing loss
Absence of opium addiction history
Do not take hypnotics and anxiety drugs
Having anxiety
Having a sleep disorder
Exclusion criteria:
Suffer from a severe physical disease
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
In this study, simple random sampling method will be used. samples of this study will be divided into two intervention and control groups using the random number table.
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 Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, 5th kilometer of Qotb –e Ravandi Blvd, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
87135/1416
Approval date
2018-06-18, 1397/03/28
Ethics committee reference number
IR.KAUMS.NUHEMP.RES.1397.014
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
2
Description of health condition studied
Quality of sleep
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
The State-Trait Anxiety
Timepoint
At the beginning of the study , end-of-trial and 4 weeks after intervention
Method of measurement
The State-Trait Anxiety Inventory
2
Description
Sleep Quality
Timepoint
At the beginning of the study , end-of-trial and 4 weeks after intervention
Method of measurement
Pittsburgh Sleep Quality Index
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 week 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
Shahid Beheshti Hospital
Full name of responsible person
Mohammad Afshar
Street address
Chemotherapy unit, Shahid beheshti hospital, Pezeshk Blvd, 5th of Qotb–e Ravandi,Kashan city, Iran
City
Kashan
Province
Isfehan
Postal code
87159.1151
Phone
+98 31 5554 0026
Fax
+98 31 5554 0026
Email
Afshar_m@kaums.ac.ir
Web page address
http://beheshti.kaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
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, Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
+98 31 5554 0022
Email
hamidi.gholamali2@gmail.com
Web page address
http://research.kaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
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
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Afshar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences, 5th kilometer of Qotb –e Ravandi Blvd, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
+98 31 5554 0022
Email
Afshar_m@kaums.ac.ir
Web page address
http://kaums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Afshar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences, 5th kilometer of Qotb –e Ravandi Blvd, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
+98 31 5554 0022
Email
Afshar_m@kaums.ac.ir
Web page address
http://kaums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Afshar_m@kaums.ac.ir
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan University of Medical Sciences, 5th kilometer of Qotb –e Ravandi Blvd, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
Email
Afshar_m@kaums.ac.ir
Web page address
http://kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD