Comparation of the effect of expressive writing on the fear of childbirth in nulliparous and primiparous/multiparous pregnant women referring to the health services centers in Isfahan in 2021
Design
Controlled clinical trial with two intervention groups(N=45) and two control groups of (nulliparous and primiparous/multiparous) in parallel groups by block randomization on 180 participants.
Settings and conduct
Out of all pregnant women referring to two comprehensive health services centers of Ebn-e-Sina and Amir-Hamzeh, the score of child birth fear will be determined with Wijma-questionnaire among the ones having study inclusion criteria and willing to participation .
Achieving score 28 or more will be included.The fear of childbirth will be measured and compared before and after intervention in two intervention groups and two control groups .
Participants/Inclusion and exclusion criteria
Iranian nationality and Persian language; Gestational age 36 weeks; Ability of reading and writing; Score 28< from Wijma questionnaire of fear of childbirth; No cesarean indications; No psychological disorders; No use of artificial reproductive technology; No history of abortion among nulliparous women; No history of infertility; Mother's tendency and consent to participation
Intervention groups
Intervention group: expressive writing will be done for 7 days at least 15 minutes daily; as, the mother will write down on a piece of paper her deepest thinks , emotions, and concerns about giving birth and the causes of her fear as well as concerns about behaviors of the personnel of delivery ward and ...
Control group: neutral writing will be done for 7 days at least 15 minutes daily about ordinary daily affairs such as cooking, cleaning, ...They will be asked to write honestly about the matters that arouse no negative/positive emotion.
Main outcome variables
Fear of childbirth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091001002531N4
Registration date:2021-11-01, 1400/08/10
Registration timing:retrospective
Last update:2021-11-01, 1400/08/10
Update count:0
Registration date
2021-11-01, 1400/08/10
Registrant information
Name
Tahmineh Dadkhahtehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7596
Email address
dadkhah-tehrani@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-20, 1400/03/30
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of expressive writing on the fear of childbirth in nulliparous and primiparous/multiparous pregnant women
Public title
"The effect of expressive writing on the fear of childbirth"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The mothers with Iranian nationality and Persian language
Pregnant mothers with gestational age 36 weeks (252 days) or more based on sonographic evidences and self declaration
Having ability of reading and writing
Achieving score 28 or more from Wijma questionnaire of fear of childbirth
Mother's tendency and consent to participation in the study
Exclusion criteria:
Use of artificial reproductive technology for becoming pregnant
History of abortion among nulliparous women
History of infertility
History of known psychological disorders( based on self declaration and information of SIB software)
Having obstetrical indications of cesarean( multiple pregnancy, placenta previa, history of surgery on uterus, skeletal malformation, and other indication of cesarean based on country protocol)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
198
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation was conducted through permuted blocked randomization (block size=4 including 2 controls and two interventions). First, using the following website(https://www.sealedenvelope.com/simple-randomiser/v1/lists ) the blocks were determined for nulliparous women then the blocks were determined for prim parous /multiparous women. So, this website was applied twice.
A= intervention
B= control
Block size: 4
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In present study; there are two categories of pregnant mothers (nulliparous and primiparous/multiparous ) and each category includes two groups of control and intervention; so totally four groups will be assessed.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Faculty of Nursing & Midwifery, Isfahan University of Medical Science, Hezarjerib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-05-24, 1400/03/03
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.011
Health conditions studied
1
Description of health condition studied
fear of childbirth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score of "Fear of childbirth" based on Wijma questionnaire
Timepoint
"Measurement of fear of childbirth before expressive writing and after a period of 7- day expressive writing"
Method of measurement
Wijma questionnaire of fear of childbirth
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: expressive writing in nulliparous pregnant women for 7 days, at least 15 minutes daily about their deepest thoughts, emotions and concerns about childbirth and the reasons for fear of childbirth, worries about the fetus during delivery, the concerns of the maternity ward staff, and any other concerns related to natural childbirth. They are also advised to discover their deepest feelings and thoughts when writing, and to put it down on paper with simple details and colloquial literature and the same words that are in their minds, and not to be concerned about the correctness of grammar or politeness of the expressions or their logical.
Category
Other
2
Description
First control group: neutral writing in nulliparous pregnant women for 7 days at least 15 minutes daily about ordinary daily affairs such as cooking, cleaning, cloths washing, shopping of foodstuff ,... .They will be asked to write honestly about the matters that arouse no negative/positive emotion.
Category
Other
3
Description
Second intervention group: expressive writing in primiparous/multiparous pregnant women for 7 days, at least 15 minutes daily about their deepest thoughts, emotions and concerns about childbirth and the reasons for fear of childbirth, worries about the fetus during delivery, the concerns of the maternity ward staff, and any other concerns related to natural childbirth. They are also advised to discover their deepest feelings and thoughts when writing, and to put it down on paper with simple details and colloquial literature and the same words that are in their minds, and not to be concerned about the correctness of grammar or politeness of the expressions or their logical.
Category
Treatment - Other
4
Description
Second control group: neutral writing in primiparous/multiparous pregnant women for 7 days at least 15 minutes daily about ordinary daily affairs such as cooking, cleaning, cloths washing, shopping of foodstuff ,..They will be asked to write honestly about the matters that arouse no negative/positive emotion.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Hamzeh Comprehensive Health Service Center
Full name of responsible person
Maryam KHalili
Street address
In front of the housing bank and the bazaarst, st. Fourth, Amir Hamzeh town, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81486-53374
Phone
+98 31 3775 7509
Email
maryamkhalili68@yahoo.com
2
Recruitment center
Name of recruitment center
Ibn Sina Comprehensive Health Service Center
Full name of responsible person
Maryam KHalili
Street address
Ebn-e-Sina Comprehensive Health Services center. Ebn-E-Sina Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81486-53374
Phone
+98 31 3445 9147
Email
maryamkhalili68@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoi Javanmard
Street address
The deputy of research and technology, bulding 4, Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Fax
Email
sh_haghjoo@med.mui.ac.ir
Web page address
https://research.mui.ac.ir/fa/dr.haghjoo
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Tahmineh Dadkhah Tehrani
Position
Instructor of Midwifery, Faculty member
Latest degree
Master
Other areas of specialty/work
Postpartum rehabilitation
Street address
Faculty of Nursing & Midwifery, Isfahan University of Medical Science, Hezarjerib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73465
Phone
+98 31 3792 7596
Email
tdtahmineh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tahmineh Dadkhah Tehrani
Position
Instructor of Midwifery, Faculty member
Latest degree
Master
Other areas of specialty/work
Postpartum rehabilitation
Street address
Faculty of Nursing & Midwifery, Isfahan University of Medical Science, Hezarjerib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73465
Phone
+98 31 3792 7596
Email
tdtahmineh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tahmineh Dadkhah Tehrani
Position
Instructor of Midwifery, Faculty member
Latest degree
Master
Other areas of specialty/work
Postpartum rehabilitation
Street address
Faculty of Nursing & Midwifery, Isfahan University of Medical Science, Hezarjerib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73465
Phone
+98 31 3792 7596
Email
tdtahmineh@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