To assess the effect of self-care counseling versus control group on quality of life in pregnant teenagers
Design
This is a randomized clinical trial with control group, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Healthcare Centers in Dargazin city on 70 eligible pregnant teenagers. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 13 to 19 years
First pregnancy
Singleton pregnancy
Gestational age of 20 weeks and above
Being literate
Exclusion criteria:
Pregnancy event
Presence of background diseases
Intervention groups
Intervention group:
Routine care during pregnancy, in addition to individually self-care counseling session for about 45 to 60 minutes a week, one session weekly for four weeks (including measuring the mother's information about self-care, checking the awareness of changes during pregnancy and the effect on the quality of life, helping the mother to express fulfilling desires and needs, teaching self-care in the field of physical, mental, and social health, identifying false beliefs in this field and increasing awareness about self-care, teaching self-care in the field of worries and concerns during pregnancy)
Control group:
Just routine care during pregnancy
Main outcome variables
Primary outcome:
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N449
Registration date:2022-12-09, 1401/09/18
Registration timing:prospective
Last update:2022-12-09, 1401/09/18
Update count:0
Registration date
2022-12-09, 1401/09/18
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self-care counseling versus control group on quality of life in pregnant teenagers: a randomized clinical trial
Public title
Effect of self-care counseling versus control group on quality of life in pregnant teenagers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 13 to 19 years
First pregnancy
Singleton pregnancy
Gestational age of 20 weeks and above
Being literate
Exclusion criteria:
Pregnancy event
Presence of background diseases
Age
From 13 years old to 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-11-17, 1401/08/26
Ethics committee reference number
IR.UMSHA.REC.1401.676
Health conditions studied
1
Description of health condition studied
Quality if life
ICD-10 code
Z73
ICD-10 code description
Problems related to life management difficulty
Primary outcomes
1
Description
Quality of life
Timepoint
Before the intervention and one month after
Method of measurement
Using the pregnancy quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care during pregnancy, in addition to individually self-care counseling session for about 45 to 60 minutes a week, one session weekly for four weeks (including measuring the mother's information about self-care, checking the awareness of changes during pregnancy and the effect on the quality of life, helping the mother to express fulfilling desires and needs, teaching self-care in the field of physical, mental, and social health, identifying false beliefs in this field and increasing awareness about self-care, teaching self-care in the field of worries and concerns during pregnancy)
Category
Treatment - Other
2
Description
Control group: Just routine care during pregnancy
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Healthcare Centers in Dargazin city
Full name of responsible person
Faeze Salehi
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
salehifaeze625@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Faeze Salehi
Position
Student of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
salehifaeze625@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Batool Khodakarami
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahrabatol2006@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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