View older revisions Content changed at 2021-01-29, 1399/11/10

Protocol summary

Study aim
The effect of midwifery counseling on fear of childbirth in fathers
Design
This study is a randomized controlled clinical trial with a blinded strain. Research community:Fathers with a pregnant spouse of 24-27 weeks covered by selected health care centers or family physician sites and earn a severe and higher score based on the Fear of Childbirth Scale that designed in Iranian fathers. Randomization: Randomized block assignment (using computer software and quadruple block selection) will be divided into two groups of 25 members, intervention and control groups.
Settings and conduct
Sampling will be done at health center in Sari. In the intervention group, the counseling program on the Skyroom has been able to. The control group will receive an individual training session after completing the last post-test questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnancy age of 24-27 weeks in spouse-Reading and writing literacy-Intense score of fear of childbirth-Consent to participate in the research Exclusion criteria:Suffering from depression, anxiety and stress-Participate in any educational and counseling programs related to pregnancy-Use of psychiatric drugs-History of hospitalization in the psychiatric ward
Intervention groups
Intervention group: Six 60-90 minute sessions (two sessions a week) in group of 25 people on the Skyroom, by a master's degree student in counseling of midwifery under the supervision of the research team. Interventions: Includes providing information on pregnancy and childbirth, Empowering fathers to deal with irrational thoughts, Attempts to explain the origin of fear of childbirth, Problem Solving and Relaxation Control group: They will receive one individual training session after completing the last post-test questionnaire.
Main outcome variables
Fear of childbirth

General information

Reason for update
Due to the outbreak of Covid disease and the subsequent ban on crowds, the intervention changed from face-to-face classes to virtual classes in the Skyroom space. According to the research team, following the change in the form of intervention, the number of sessions, the time of intervention and the number of people in each group also changed.
Acronym
IRCT registration information
IRCT registration number: IRCT20150608022609N6
Registration date: 2019-12-04, 1398/09/13
Registration timing: registered_while_recruiting

Last update: 2021-01-29, 1399/11/10
Update count: 2
Registration date
2019-12-04, 1398/09/13
Registrant information
Name
Zohre Shahhosseini
Name of organization / entity
Mazandaran Univercity of Medical Science, Nasibe School Of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
z.shahhosseini@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-21, 1398/08/30
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of midwife-led counseling on fear of childbirth in fathers
Public title
The effect of midwife-led counseling on fear of childbirth
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnancy age 24-27 weeks in spouse Severe and higher childbirth fear score (Based on a Father’s Fear of Childbirth Scale) Literacy for reading and writing Consent to participate in the research
Exclusion criteria:
Suffering from depression, anxiety and stress based on the Depression, Anxiety and Stress Scale-21 (DASS-21) Participate in any educational and counseling programs related to pregnancy and childbirth up to six months before and during the study Use of psychiatric drugs (current or history of use) Hospitalization history in the psychiatric ward
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done as a randomized block assignment. In this method, given that there are two intervention and control groups, quad blocking will be employed, in which each block will be two in the intervention group and two in the control group. Then the software will give us the different modes that these four people can come together. For example, the first two people who enter the study may both fall into the intervention group either fall into the control group or the first into the control group and the second into the intervention group or the first person in the intervention group and the second in the control group. Thus, based on the software output, these 50 individuals will be assigned to one of the intervention or control groups.
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 Mazandaran University of Medical Sciences
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2019-09-30, 1398/07/08
Ethics committee reference number
IR.MAZUMS.REC.1398.899

Health conditions studied

1

Description of health condition studied
Fear of childbirth
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
fear of childbirth
Timepoint
Pre-intervention, immediately and one month after intervention
Method of measurement
Father's Fear of Childbirth Scale

Secondary outcomes

1

Description
self efficacy
Timepoint
Before the intervention, immediately and one month after the intervention
Method of measurement
General self-efficacy scale

2

Description
Selective delivery type
Timepoint
Before the intervention, immediately and one month after the intervention
Method of measurement
In the form of a question

3

Description
Satisfaction with the intervention
Timepoint
immediately and one month after the intervention
Method of measurement
Visual Analog Scale: Satisfaction

Intervention groups

1

Description
Intervention group: In the intervention group, 6 sessions of 60-90 minutes (two session per week) will receive interventions (Includes providing information on pregnancy and childbirth, Teaching the concept of rational and irrational thoughts and empowering fathers to deal with irrational thoughts, Attempts to explain the origin of fear of childbirth, Problem Solving and Relaxation) in a group of 25 members in the Skyroom.
Category
Behavior

2

Description
Control group: Will receive routine care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Sari health centers
Full name of responsible person
Aghil Barzegar
Street address
Sari County Health Center, Amir Mazandaran St, Shahband St, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
4816711447
Phone
+98 11 3339 4752
Fax
Email
fateme.gfr@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Akbar Hedayatizadeh Omran
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences, Moallem Square, Moallem Avenue
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3325 7230
Email
akbar-hedayati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Ghaffari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Shirazi Avenue
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
009833374750
Email
fateme.gfr@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Shahhosseini
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Shirazi Avenue
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3337 4750
Email
zshahhosseini@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Ghaffari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nasibeh Nursin and Midwifery Faculty, Vesal Shirazi Avenue
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3337 4750
Email
fateme.gfr@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
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