Protocol summary
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Study aim
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The effect of midwifery counseling on fear of childbirth in fathers
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Fear of childbirth
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2019-12-04, 1398/09/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-21, 1398/08/30
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Expected recruitment end date
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2020-02-19, 1398/11/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of midwife-led counseling on fear of childbirth in fathers
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Public title
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The effect of midwife-led counseling on fear of childbirth
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-09-30, 1398/07/08
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Ethics committee reference number
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IR.MAZUMS.REC.1398.899
Health conditions studied
1
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Description of health condition studied
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Fear of childbirth
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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fear of childbirth
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Timepoint
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Pre-intervention, immediately and one month after intervention
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Method of measurement
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Father's Fear of Childbirth Scale
Secondary outcomes
1
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Description
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self efficacy
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Timepoint
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Before the intervention, immediately and one month after the intervention
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Method of measurement
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General self-efficacy scale
2
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Description
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Selective delivery type
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Timepoint
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Before the intervention, immediately and one month after the intervention
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Method of measurement
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In the form of a question
3
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Description
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Satisfaction with the intervention
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Timepoint
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immediately and one month after the intervention
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Method of measurement
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Visual Analog Scale: Satisfaction
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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Control group: Will receive routine care.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available