Protocol summary
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Study aim
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To assess the effect of progressive muscle relaxation technique versus control group on the fear related to pregnancy and childbirth in primiparous women
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Design
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This is a randomized clinical trial, in which 60 eligible primiparous women will be randomly assigned to the intervention and control groups
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Settings and conduct
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The primiparous women who will refer to Comprehensive health Centers in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age of 18 to 30 years,
Gestational age of 29 to 32 weeks,
Monogamy,
Primiparous women,
Being literate,
A resident of Hamadan,
Ability to do exercises for 20 minutes daily,
Exclusion criteria:
Using opium or psychotropic drugs,
Mental disorders,
Pregnancy complications,
Fetal malformation
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Intervention groups
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Intervention group:
Routine prenatal care plus educating progressive muscle relaxation techniques for 30 minutes twice a week for 4 weeks
Control group:
Just routine prenatal care
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Main outcome variables
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The fear related to pregnancy and childbirth
General information
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Reason for update
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Change in methods due to logistic limitation
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120215009014N317
Registration date:
2019-11-25, 1398/09/04
Registration timing:
registered_while_recruiting
Last update:
2023-07-27, 1402/05/05
Update count:
2
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Registration date
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2019-11-25, 1398/09/04
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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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2019-11-22, 1398/09/01
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Expected recruitment end date
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2020-11-20, 1399/08/30
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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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Effect progressive muscle relaxation technique versus control group on the fear related to pregnancy and childbirth in primiparous women: a randomized clinical trial
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Public title
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Effect progressive muscle relaxation technique versus control group on the fear related to pregnancy and childbirth in primiparous women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 18 to 30 years,
Gestational age of 29 to 32 weeks,
Monogamy,
Primiparous women,
Being literate,
Resident of Hamadan,
Ability to do exercises for 20 minutes daily,
Exclusion criteria:
Using opium or psychotropic drugs,
Mental disorders,
Pregnancy complications,
Fetal malformation
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Age
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From 18 years old to 30 years old
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Gender
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Female
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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:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
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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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2019-10-26, 1398/08/04
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Ethics committee reference number
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IR.UMSHA.REC.1398.616
Health conditions studied
1
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Description of health condition studied
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Fear related to pregnancy and childbirth
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ICD-10 code
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F40.298
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ICD-10 code description
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Other specified phobia
Primary outcomes
1
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Description
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The fear related to pregnancy and childbirth
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Timepoint
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Before the intervention and 4 weeks after that
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Method of measurement
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Using a standard questionnaire
Intervention groups
1
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Description
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Intervention group: Routine prenatal care plus educating progressive muscle relaxation techniques for 30 minutes twice a week for 4 weeks
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Category
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Other
2
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Description
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Control group: Just routine prenatal 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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Hamedan 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