Determination of The Effect of Relaxation on Depression and Anxiety in Mothers of Children with Cerebral Palsy
Design
Clinical trial with control group, parallel group, single blind, randomized with simple randomization technique using Random Digits Table.
Settings and conduct
This study was conducted a demographic inventory and Depression Anxiety Stress Scale-21( DASS-21) to collect data.The location of the study are the rehabilitation centers in Urmia city.In order to blind the study for sampling steps, random allocation of samples to two intervention and control groups, intervention and data collection before and after the study, two trained clinical psychologists with a master's degree in clinical psychology are used. In this way, the main researcher and the analyst in this study are blinded. They are unaware of the grouping. Groups are provided with A and B.
Participants/Inclusion and exclusion criteria
Inclusion criteria:The mothers with a child with cerebral palsy between 6 month to above
-DASS score in mothers:depression between 10 to 28 and anxiety between 8 to 20
-To be content to participate in the study
-ability to understand Persian language
Exclusion criteria:- Chronic or incurable disease in a family member
- Severe stress in the last year.
- Unemployment or addiction of the spouse
- History of severe anxiety, major depression, or other mental disorders before a child is diagnosed with cerebral palsy
Intervention groups
Intervention group: 30 mothers of children with cerebral palsy, 6 weeks Relaxation in home
Control group:30 mothers of children with cerebral palsy, No Intervention
Main outcome variables
Depression levels of mothers with children with cerebral palsy based on the scale of depression, anxiety and stress (DASS-21)
The level of anxiety of mothers with children with cerebral palsy based on the scale of depression, anxiety and stress (DASS-21)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200211046457N1
Registration date:2020-06-02, 1399/03/13
Registration timing:prospective
Last update:2020-06-02, 1399/03/13
Update count:0
Registration date
2020-06-02, 1399/03/13
Registrant information
Name
Maryam Shahrifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3336 9416
Email address
m.shahrifar@iaurmia.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-02, 1399/04/12
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Relaxation on Depression and Anxiety in Mothers of Children with Cerebral Palsy.(The Clinical Trial)
Public title
The Effect of Relaxation on Depression and Anxiety in Mothers of Children with Cerebral Palsy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The mothers with a child with cerebral palsy between 6 month to above
DASS score in mothers:depression between 10 to 28 and anxiety between 8 to 20
To be content to participate in the study
ability to understand Persian language
Exclusion criteria:
Chronic disease in one of the members of family
Severe stress (death, hard disease, divorce …)
Unemployment or addiction in husband
Record of Anxiety, major Depression, Addiction or other Mental Disorder in mother
Psychology Drugs user
Age
From 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are randomly into two groups of intervention and control, with simple randomization technique using Random Digits Table.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind the study for sampling steps, random allocation of samples to two intervention and control groups, intervention and data collection before and after the study, two trained clinical psychologists with a master's degree in clinical psychology are used.In this way, the main researcher and the analyst in this study are blinded. They are unaware of the grouping. Groups are provided with A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Islamic Azad University Urmia Branch
Street address
(Ayatollah Rafsanjani Complex), On then 2th Kilometer of Airport Rd, Urmia Islamic Azad University
City
urmia
Province
West Azarbaijan
Postal code
57169-63896
Approval date
2018-11-05, 1397/08/14
Ethics committee reference number
IR.IAU.URMIA.REC.1397.011
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
2
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
3
Description of health condition studied
Cerebral Palsy
ICD-10 code
G80
ICD-10 code description
Cerebral palsy
Primary outcomes
1
Description
Depression: The score used by the DASS -21 questionnaire
Timepoint
Before the intervention, six weeks after the intervention
Method of measurement
Depression- Anxiety- Stress Scale (DASS -21)
2
Description
Anxiety: The score used by the DASS -21 questionnaire
Timepoint
Before the intervention, six weeks after the intervention
Method of measurement
Depression- Anxiety- Stress Scale (DASS -21)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 6 weeks Relaxation in home - Based on the individual lesson plan,Progressive Muscle Relaxation Techniques, Deep Breathing and Mental Imagery techniques will be taught individually in 3 to 4 one-hour sessions at intervals of 3 to 5 days. A compact disc containing the first and second steps of relaxation and an educational booklet taken from the book Relaxation in Zarfa written by Bahadoran and Pournaseh will be provided to the test group. Each relaxation step takes about 15 minutes The test group is asked to perform relaxation exercises once a day according to the program set at home. In order to ensure the correct implementation of relaxation according to the plan, along with the training booklet, the general stress registration form is given to the test group before and after the relaxation and they are asked to perform their general stress based on scale 1 to 10 before and after. Record sedation each time. According to this form, only those who have completed at least 70% of the developed program will be evaluated and the rest will be excluded from the study.
Category
Behavior
2
Description
Control group: No Intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheykh Raees Rehabilitation center
Full name of responsible person
Romina Baghi Zade
Street address
No.106, Mandegar Commercial Center, Hasani Ave
City
Urmia
Province
West Azarbaijan
Postal code
5715859423
Phone
+98 44 3348 4586
Email
sheykhoraeesreha312@yahoo.com
2
Recruitment center
Name of recruitment center
Ehsan Rehabilitation Center
Full name of responsible person
Naser Zare
Street address
Santa Maria Clinic, Abolfathi St, 8 Shahrivar Ave
City
Urmia
Province
West Azarbaijan
Postal code
5716144772
Phone
+98 44 3348 1927
Email
ojeerob@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahdi Zavaree
Street address
Urmia Islamic Azad University, on then 2th Kilometer of Airport Rd
City
Urmia
Province
West Azarbaijan
Postal code
5716963896
Phone
+98 44 3180 3000
Email
info@iaurmia.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
10
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
Islamic Azad University
Full name of responsible person
Maryam Shahrifar
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
NO.91,Tamkinvash St,Nabovat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5719854669
Phone
009833369416
Email
m.shahrifar@iaurmia.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Shahrifar
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
NO.91,Tamkinvash St,Nabovat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5719854669
Phone
+98 44 3336 9416
Fax
Email
m.shahrifar@iaurmia.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Shahrifar
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
NO.91,Tamkinvash St,Nabovat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5719854669
Phone
009833369416
Email
m.shahrifar@iaurmia.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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available