In this randomized clinical trial, conducted at Ghaem and Doctor Sheikh hospitals of Mashhad, a developmental stimulation package was utilized. Fifty toddler with the age of 12-36 months eligible according to inclusion criterion were randomly divided into the intervention (25) and control (25) groups.Then, the developmental stimulation program was administered for children in the intervention group, three times a week for 8 consecutive weeks (24 sessions, each two hours). psychosocial, Language, Fine and Gross motor developmental age of the children was assessed by the Bayley Scales of Infant and Toddler Development, before the intervention, 2 and 4 months after the intervention. Control group received routine care in hospital.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021521090N1
Registration date:2015-07-13, 1394/04/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-13, 1394/04/22
Registrant information
Name
Elahe Ghayebie
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3728 1015
Email address
ghayebie921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Mashhad University of Medical Sciences
Expected recruitment start date
2015-01-03, 1393/10/13
Expected recruitment end date
2015-05-05, 1394/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect developmental stimulation on development criteria in child 3-1 years old with celiac disease
Public title
Developmental stimulation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:children between 3-1 years old, celiac diseases by physicians with pediatric gastroenterologist confirmed, Along with celiac disease and not other physical and mental, Exclusion criteria:unwillingness to cooperate in the study of parents and children for any reason, the child's death or hospitalization during the study
Age
From 1 year old to 3 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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 Mashhad University of Medical Sciences
Street address
Building Qureshi, Daneshgah street, Taghi Abad, Mashhad--
City
Mashhad
Postal code
Approval date
2015-01-03, 1393/10/13
Ethics committee reference number
930524
Health conditions studied
1
Description of health condition studied
celiac disease
ICD-10 code
k90.0
ICD-10 code description
Coeliac disease
Primary outcomes
1
Description
developmental riteria
Timepoint
post intervention, after and 4 mounth after intervention
Method of measurement
bayley scale infant and toddler developmental 3
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group:The intervention group at 3 sessions per week for 24 sessions held over a 5 hour stimulation according to the guidelines"west Virginia"
Category
Other
2
Description
Control Group: in the control group there was no intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr Seyed Ali Jafari
Street address
Ahmad Abad street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Mashhad University of Medical Sciences
Full name of responsible person
Saed Eslami
Street address
Taghi Abad, Daneshgah street, Building Qureshi
City
Mashad
Grant name
Grant code / Reference number
930524
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Mashhad 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
Mashhad Univercity of Medical Science
Full name of responsible person
Elahe Ghayebie
Position
MS in Pediatric Nursing, School of Nursing and Midwifery
Other areas of specialty/work
Street address
Mashhad, Daneshgah street, School of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3728 1015
Fax
Email
Ghayebie921@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Akram Rezaeian
Position
MS Nursing
Other areas of specialty/work
Street address
Mashhad, Daneshgah street, School of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3882 8440
Fax
Email
RezaeianA@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Elahe Ghayebie
Position
Other areas of specialty/work
Street address
Mashhad, Daneshgah street, School of Nursing and Midwifery
City
Mashhad
Postal code
Phone
+98 51 3728 1015
Fax
+98 51 3728 1015
Email
Ghayebie921@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)