The aim of this study was to evaluate the effect of continuous care model on mental health and quality of life in mothers of children with cerebral palsy.
Design
The present study is a clinical trial study with parallel groups that will be performed on 100 mothers of children with cerebral palsy. Randomization will be done with random blocks allocation.
Settings and conduct
After obtaining informed consent, mothers will be randomly assigned to one of the two intervention and control groups. In both groups, quality of life and mental health will be measured before the intervention. In the control group, only mothers will be provided with routine education about their child's illness and other care. The intervention group will be under continuous care for two months. The quality of life and mental health of both groups will be measured again at the end of the first and second months using the mentioned questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mothers with children 4 to 12 year-old with cerebral palsy hospitalized and no specific problems affecting the mental health of mothers such as financial crisis.
Exclusion criteria: mothers suffering from mental illness and severe anxiety.
Intervention groups
In the control group, routine education about child's illness and other care will be provided for mothers. In the intervention group, first the quality of life and mental health questionnaire will be completed by the mothers and then this group will be under continuous care follow up for two months
Main outcome variables
Mental health; quality of life.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200112046102N1
Registration date:2020-11-09, 1399/08/19
Registration timing:registered_while_recruiting
Last update:2020-11-09, 1399/08/19
Update count:0
Registration date
2020-11-09, 1399/08/19
Registrant information
Name
Somaye Pouy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 5056
Email address
somayepouy@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of continuous care model on psychiatry health and quality of life in mothers of children with cerebral palsy
Public title
Survey the effect of continuous care model on psychiatry health and quality of life in mothers of children with cerebral palsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1-mothers who have 4 to 12 year-old hospitalized children with cerebral palsy
2- parents not working in health systems
3- no special problem affecting mothers' mental health such as financial crisis.
Exclusion criteria:
Exclusion criteria are: mothers suffer from mental illness and severe anxiety.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random blocks and "Random allocation software" will be used for randomization. Given that we have two groups, four blocks will be used. The sequence of groups in each block will be determined by the software. To start, the first block is selected by lottery and then this process will be done until the sampling is completed
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 Guilan University of Medical Sciences
Street address
Daneshjoo Ave., Yakhsazi BLV., Rasht
City
Rasht
Province
Guilan
Postal code
1267348934
Approval date
2019-03-16, 1397/12/25
Ethics committee reference number
IR.GUMS.REC.1397.526
Health conditions studied
1
Description of health condition studied
Quality of life
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Mental health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of life
Timepoint
The quality of life of both groups will be measured in three time periods, including after discharge, at the end of the first month and the second month.
Method of measurement
Quality of life will be measured using a short form of quality of life.
2
Description
Mental health
Timepoint
Mental health of both groups will be measured in three time periods, including after discharge, at the end of the first month and the second month.
Method of measurement
Mental health will be assessed by the General Psychological Health Questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention will be performed face to face and includes four training stages of the continuous care model in the internal ward of 17-Shahrivar Hospital in Rasht. In this way, after introducing themselves to the mothers and justifying the goals and methods of work and obtaining informed written consent, the researcher will be provided with mental health and quality of life questionnaires to mothers, and therefore mothers' mental health and quality of life before the intervention will be assessed. The continues care model will then be implemented for two months. The continues care model, which is the native care model of Iran, consists of four stages, which include the stage of identification, sensitization, control and evaluation. In the introductory phase, an hour-long session will be held with the presence of mothers with children with cerebral palsy. In person and by phone. In the sensitization phase, childcare counseling will be conducted both in person in six sessions and by telephone. At this stage, understanding the nature of the disease, early and late complications, how to use their child's medications, how to control anxiety and worry, strategies to improve mental health and quality of life such as following a healthy lifestyle, exercising, avoiding stress and anxiety They will be given and any questions and concerns will be answered. In the control phase, follow-up care counseling and re-sensitization will be provided on a weekly basis by telephone to review the achievement of follow-up care goals. In the evaluation phase, the researcher will examine the mothers. Then the quality of life and mental health will be measured again at the end of the first and second month using the mentioned questionnaires.
Category
N/A
2
Description
Control group: In the control group, quality of life and mental health questionnaires will be provided to them and only mothers will be provided with routine education about their child's illness and other care provided by the ward nurses. Quality of life and mental health will be measured again at the end of the first and second months using the mentioned questionnaires.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Rasht hospital
Full name of responsible person
Somaye Pouy
Street address
Pediatric hospital, Azodi Ave., Rasht.
City
Rasht
Province
Guilan
Postal code
4165567132
Phone
+98 13 3336 9391
Email
somayepouy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Naghipour
Street address
Deputy of Research and Technology, Azodi Ave., Rasht.
City
Rasht
Province
Guilan
Postal code
5412874528
Phone
+98 13 3355 7802
Email
M.naghipour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Somaye Pouy
Position
PhD student in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yasin Ave., Daneshjo Park, Rasht
City
Rasht
Province
Guilan
Postal code
4144643199
Phone
+98 13 3355 7807
Email
somayepouy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Somaye Pouy
Position
PhD student in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yasin Ave., Daneshjo Park, Rasht
City
Rasht
Province
Guilan
Postal code
4144643199
Phone
+98 13 3355 7807
Email
somayepouy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Somaye Pouy
Position
PhD student in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yasin Ave., Daneshjo Park, Rasht
City
Rasht
Province
Guilan
Postal code
4144643199
Phone
+98 13 3355 7807
Email
somayepouy@gmail.com
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