Determining the effect of family-centered education on tele-nursing method on emotional reactions of mothers of children after bone marrow transplantation
Design
Clinical trials including control and intervention groups. Blind on one side. by accident
Settings and conduct
Children's Medical Center. Bone marrow transplantation ward
Participants/Inclusion and exclusion criteria
Mothers aged between 20 and 45. 2. Have complete satisfaction to participate in research. 3. Have reading and writing skills. 4. Absence of psychological disorders and psychotropic pill consumption at the start of research. 5. Lack of learning problems and diseases directly related to learning. 6. Having a smartphone and the ability to connect to the Internet and know how to use it
Intervention groups
33 Mothers who are trained through Wattsap software
Main outcome variables
Emotional reactions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181112041628N1
Registration date:2019-01-19, 1397/10/29
Registration timing:registered_while_recruiting
Last update:2019-01-19, 1397/10/29
Update count:0
Registration date
2019-01-19, 1397/10/29
Registrant information
Name
hadie solati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5540 4784
Email address
hadie.solti@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of family-centered education on tele-nursing method on emotional reactions of mothers after bone marrow transplantation
Public title
The Effect of Tele Nursing Training on the Mental Status of Mothers of Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1- Mothers aged between 20 and 45 2. Have complete satisfaction to participate in research 3- Have reading and writing skills 4. No psychiatric disorders and psychotropic drugs in the onset of research 5- No learning problems and diseases that directly affect Learning has an impact. 6. Having a smartphone and the ability to connect to the Internet and know how to use it
Exclusion criteria:
Child's death during the research 2. Failure to connect to the Internet and lack of mother participation in the training process for one month or more 3- The mother's disease to mental problems and the need for psychedelic pills during the study period 4-Unwilling to participate in the study
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were randomly waxed envelope in 33 individuals in the control group and 33 in the intervention group
Blinding (investigator's opinion)
Single blinded
Blinding description
After discharge, mothers will be randomly assigned to two groups of intervention and control. The control group and the intervention group will receive the training according to the routine section after the discharge, individually, and will contact the department in case of difficulty and the intervention group, in addition to the training, Individuals will receive tele nursing training in the Watts app and their problems will be reviewed and organized.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
Tehran University of Medical Sciences, Zargande street, Danesh alley
City
Tehran
Province
Tehran
Postal code
1331994591
Approval date
2018-10-06, 1397/07/14
Ethics committee reference number
IR.IAU.TMU.REC.1397.174
Health conditions studied
1
Description of health condition studied
Bone marrow transplantation
ICD-10 code
F30-F39
ICD-10 code description
Mood disorders
Primary outcomes
1
Description
Emotional reactions (depression, stress and anxiety)
Timepoint
40 day
Method of measurement
DAS questionnaire
2
Description
Emotional responses of mothers are measured after discharge
Timepoint
The next 40 days are measured again
Method of measurement
Depression and Anxiety Stress Measurement Questionnaire
Secondary outcomes
1
Description
stress
Timepoint
Before the intervention and 40 days after the intervention in the intervention group and in the control group, 40 days after the first and second
Method of measurement
depression anxiety Stress scale questionnaire
2
Description
Depression
Timepoint
Before the intervention and 40 days after the intervention in the intervention group and in the control group, 40 days after the first and second
Method of measurement
depression anxiety Stress scale questionnaire
3
Description
Anxiety
Timepoint
Before the intervention and 40 days after the intervention in the intervention group and in the control group, 40 days after the first and second
Method of measurement
depression anxiety Stress scale questionnaire
Intervention groups
1
Description
The intervention group consisted of 33 mothers after discharge who were routinely trained in routine and individual care, as well as intermittently via Watts-up software for 40 days. routine and individual education package includes health, nutrition, treatment follow-up, and question and answer.
Category
Other
2
Description
Control group: The control group consisted of 33 nurses who received post-discharge education in a routine, individual and one-time delivery.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Hadie solati
Street address
Children's Medical Center Hospital, Boulevard Keshavarz Tehran
City
Tehran
Province
Tehran
Postal code
1331994591
Phone
+98 21 6692 2115
Email
Hadie.solati@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad hashemiyan
Street address
University of Medical Sciences,Danesh alley, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
193951495
Phone
+98 21 2200 6660
Email
hashemian.f@iaups.ac.ir
Web page address
http://www.iautmu.ac.ir/research/index.asp
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
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
Islamic Azad University
Full name of responsible person
Mohamad Sahebzamane
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Sixth floor,Central Islamic Azad University Building.Boulevard Hesarak,Sattary Highway, University square
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4735 1601
Email
m_szamani@iautmn.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Sahebzamani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Sixth floor,Central building Azad University ,boulevard Hesarak,University Square,Sattary highway ,Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
m_szamani@iautmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohamad Sahebzamani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Sixth Floor, Central Building of Azad University, Hesarak Blvd,University Square.Sattari Highway.Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 44865154
Email
m_szamani@iautmu.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
No - There is not 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
No - There is not a plan to make this available
Clinical Study Report
Not applicable
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