Determine of the effect of Guided Imagery on fatigue, stigma, and mood in patients with Multiple Sclerosis
Design
This study is a clinical trial with two groups (intervention and control), double blinded (the data analyst and participants) and randomized, with 30 patients in each group.
Settings and conduct
This double blinded study (the data analyst and participants), will be done in the Kerman Medical Center of the Special Diseases. In the intervention group, 48 sessions of Guided Imagery will be performed in 4 weeks and six sessions per week in two turns at the morning (between 08:00 and 09:00) and in the evening (between 20:00 and 21:00). The variables will be measured before and four weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Full consciousness؛ acceptable ability to hear, see and speak؛ have ability to read and write in Persian language؛ diagnosis of Relapsing-Remitting Multiple Sclerosis by neurologist؛ getting a degree of fatigue less than average 6 based on Fatigue Severity Scale (FSS) questionnaire; Use of sedatives, antidepressants and narcotics؛ No existence of a history of mental illness and hospitalization continuously؛ No other neurological disorders؛ No previous experience use of relaxation techniques (including Guided Imagery).
Intervention groups
In the intervention group, 48 sessions of Guided Imagery will be performed in 4 weeks and six sessions per week in two turns at the morning (between 08:00 and 09:00) and in the evening (between 20:00 and 21:00), While patients in the control group will receive routine care. The severity of fatigue, stigma, and mood score will be measured before and four weeks after the intervention.
Main outcome variables
Fatigue, Stigma and Mood
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151107024919N11
Registration date:2020-10-22, 1399/08/01
Registration timing:retrospective
Last update:2020-10-22, 1399/08/01
Update count:0
Registration date
2020-10-22, 1399/08/01
Registrant information
Name
Batoul Tirgari
Name of organization / entity
Kerman Medical University of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5207
Email address
b_tirgari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of effectiveness of Guided Imagery on fatigue, stigma, and mood in patients with Multiple Sclerosis
Public title
Effect of Guided Imagery on fatigue, stigma, and mood in patients with Multiple Sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Full consciousness
Acceptable ability to hear, see and speak
Have ability to read and write in Persian language
Diagnosis of Relapsing-Remitting Multiple Sclerosis by neurologist
Getting a degree of fatigue less than average 6 based on Fatigue Severity Scale (FSS) questionnaire
Exclusion criteria:
Use of sedatives, antidepressants and narcotics
Existence of a history of mental illness and hospitalization continuously
Getting other neurological disorders
Previous experience use of relaxation techniques (including Guided Imagery)
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to allocate the subjects to the intervention and control groups,a randomized block method is used, Block randomization method is a method in which participants are randomly selected in terms of severity of fatigue, type of disease, duration of illness, numbers of recurrences per year, family history of the Multiple sclerosis disease, etc are placed in the blocks. Subsequently, through the use of a simple method and using R Test from each group, half of the subjects are placed in the intervention group and the other half are in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Given that the intervention takes place at home; this study is double-blind. the data analyst do not know which data is related to the intervention group and which data is related to the control group, and participants do not know in which intervention or control group they were placed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Medical Center of the Special Diseases., No. 78 Alley., Shahid Rajaee Street.,
City
Kerman
Province
Kerman
Postal code
7619875994
Approval date
2020-07-06, 1399/04/16
Ethics committee reference number
IR.KMU.REC.1399.263
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Fatigue
Timepoint
The severity of fatigue will be measured before and four weeks after the end of the intervention
Method of measurement
Fatigue severity scale
2
Description
Stigma
Timepoint
The severity of stigma will be measured before and four weeks after the end of the intervention
Method of measurement
Reece Stigma Scale_Multiple Sclerosis
3
Description
Mood
Timepoint
The severity of mood will be measured before and four weeks after the end of the intervention
Method of measurement
Profile Of Mood State
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, 48 sessions of guided imagery will be performed in 4 weeks and six sessions per week in two turns at the morning (between 08:00 and 09:00) and in the evening (between 20:00 and 21:00). Morning and evening sessions will be held at the patient's home. Patients will listen to the Audio- Recorded Guided Imagery Script for 25 minutes via headphone and will follow the instructions. Also, disturbing noises will be controlled through meetings formation in quiet rooms. Also at home, it is attempted to allocate a room for the patient to listen to the Audio-Recorded Guided Imagery Script with the coordination of the patient and the family.
Category
N/A
2
Description
Control group: Patients in the control group received routine cares.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical Center of the Special Diseases
Full name of responsible person
Batool Tirgari
Street address
Medical Center of the Special Diseases., No. 78 Alley., Shahid Rajaee Street.,
City
Kerman
Province
Kerman
Postal code
7619875994
Phone
+98 34 3271 2001
Fax
+98 34 3271 2127
Email
b_tirgari@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/snm
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
No 2, Research and Technology Dept., Ibn Sina Ave., Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3121 7213
Email
abpardakhty@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/vcrt
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences,Medical University of Campus, Haft- Bagh - alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
b_tirgari@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/snm
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Fax
+98 34 3132 5184
Email
b_tirgari@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Fax
+98 34 3132 5184
Email
b_tirgari@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available