determining the effect of spiritual self-care program on anxiety in pregnant women with preterm labor pain
Design
Non blind randomized clinical trial
Settings and conduct
Seventy eligible pregnant women who refer to Shahid Beheshti hospital, Kashan, Iran, will enroll to the study. Intervention will be done through five integrative educational sessions; two face to face and group educational sessions and three mobile-based educational sessions. content of education is adopted by the Kajbaf etal's spiritual care package.
Participants/Inclusion and exclusion criteria
The inclusion criteria include age at least 18 years, education at least diploma status, having a android cell phone, primary parus, gestational age between 30 to 34 weeks; exclusion criteria include use of psychiatric drugs and drugs associated with thyroid disorders, positive history of well-known anxiety disorders, participation in religious ceremonies and undergraduate courses by a pregnant mother or her husband, absence of more than one session of educational classes in intervention group, preterm delivery during the intervention and unwilling to continue the cooperation in the research.
Intervention groups
the first group is the intervention group and the second group is control group
Main outcome variables
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160808029255N2
Registration date:2018-05-21, 1397/02/31
Registration timing:registered_while_recruiting
Last update:2018-05-21, 1397/02/31
Update count:0
Registration date
2018-05-21, 1397/02/31
Registrant information
Name
Raziyeh Maasoumi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4214
Email address
r_masoumi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-10-12, 1397/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of spiritual self-care program on anxiety in pregnant women with preterm labor pain: a randomized clinical trial
Public title
The effect of spiritual self-care program on anxiety in pregnancy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
age at least 18 years
education at least diploma status
having android cell phone
primary parus
gestational age between 30 to 34 weeks
Exclusion criteria:
use of psychiatric drugs and drugs associated with thyroid disorders
positive history of well-known anxiety disorders
participation in the religious ceremonies and related undergraduate courses by pregnant mother or her husband
Age
From 18 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
Participants are divided randomly into two groups; the first group as the intervention group and the second group as the control group.
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 Tehran University of Medical Sciences Nursing and Midwifery Care Research Center
Street address
south Nosrat Ave., Towhid Sq., Tehran city
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-12-16, 1396/09/25
Ethics committee reference number
IR.TUMS.FNM.REC.1396.4274
Health conditions studied
1
Description of health condition studied
on anxiety in pregnant womenwith preterm labor pain
ICD-10 code
F06.4
ICD-10 code description
Organic anxiety disorder
Primary outcomes
1
Description
Pregnancy anxiety
Timepoint
Before intervention. Immediately after the end of the intervention. One month after the end of the intervention
Method of measurement
Pregnancy Related Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The method of work in the intervention group is a combination of in-person and virtual training. Two in-person sessions will be held by the researcher for 90 minutes based on spiritual therapy package,s Kajbaff et al. (37). So that these two sessions will be held within a week at intervals of five days (beginning and end of the week).Teaching is organized a group in a classroom and the researcher will use lecture and question and answer methods, as well as the teaching materials will include a panel, a marker and a brochure. Three training sessions will be held virtual and the content of each one will be available through the telegram program within five days and will be followed up by phone call with each participant to receive and study it.
Category
Behavior
2
Description
Control group: These persons will not receive any spiritual self-care education.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti hospital in the city of Kashan
Full name of responsible person
Dr Raziyeh Masoomi
Street address
Qotbe Ravadi bulvar
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0021
Email
r_masoumi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh masoumi
Street address
South Nosrat
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research and Technology of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Position
assisstant proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
South Nosrath
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Position
academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
south nosrath
City
tehran
Province
Tehran
Postal code
1419733171
Phone
+98 61054214
Email
r_masoumi@sina.tumc.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Raziyeh Maasoumi
Position
Pos.doc of Sexology, PhD of Reproductive Health, Assisstent Professor of Reproductive Health Departm
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Fax
Email
r_masoumi@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data of the study would be available after unrecognizable process of participants
When the data will become available and for how long
Six months after publication of findings
To whom data/document is available
Data of this research would be be available for academic researches
Under which criteria data/document could be used
Data of this study would be available only same research
From where data/document is obtainable
Dr. Raziyeh Maasoumi
email: r_masoumi@sina.tums.ac.ir
What processes are involved for a request to access data/document
Sending a request by email
attendance to the office of corresponding of project
presentation the reasons for similarity of two projects
studying the proposal by corresponding of project
final decision making with corresponding author
access of data in office of corresponding author