Protocol summary
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Study aim
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Determining the effectiveness of Emotional Freedom Technique on fear of childbirth in nulliparous women
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Design
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Clinical trial with control and intervention group, one-way blind, randomized, on 116 nulliparous women, permutation blocks with block size 6 were used for randomization.
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Settings and conduct
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Clinical trial in Shahid Shafiei and Sadoughi health centers in Yasouj is in the form of two intervention and control groups. The order of the researcher and the participants will be unaware of who is in which group until the beginning of the study. Intervention in this study from the age of 28 to 30 weeks of pregnancy, beginning and end of postpartum intervention The questionnaire that is completed at the beginning of the study (fear of childbirth Vijma version A) to study will be a pre-test for both intervention and control groups, then the intervention group and the control group in the same way using points False for two sessions of face-to-face training and 10 weeks of face-to-face training and follow-up, the researcher learns the technique of mind liberation.
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Participants/Inclusion and exclusion criteria
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include: Gestational age 28 to 30 weeks; primiparous; scoring more than 37 in the Vijama questionnaire
Exclusion : suffering from mental illness during the last year and taking psychotropic drugs
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Intervention groups
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Intervention group: tapping the parts of the face and body with the fingertips, which include: the beginning of the eyebrows, around the eyes, under the eyes, under the lips, chin, clavicle and armpits.
Control group: They also hit in the same way by using false points, ie points other than the points of the introduced acupressure.
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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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The age of the people included in the study is 18 years and above, and the age of 15 is considered a teenager and requires parental permission
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210622051671N1
Registration date:
2021-07-31, 1400/05/09
Registration timing:
registered_while_recruiting
Last update:
2023-01-17, 1401/10/27
Update count:
2
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Registration date
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2021-07-31, 1400/05/09
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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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2021-07-24, 1400/05/02
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Expected recruitment end date
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2021-12-21, 1400/09/30
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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 effectiveness of Emotional Freedom Technique on fear of childbirth in nulliparous women
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Public title
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The effectiveness of Emotional Freedom Technique on fear of childbirth in nulliparous women
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Minimum primary education
Gestational age 28 to 30 weeks
Nulliparous
Earn more than 37 points in the Vijama questionnaire
Exclusion criteria:
Chronic diseases such as heart disease, high blood pressure, diabetes
History of abortion
Placenta previa
Suffering from mental illness during the last year and taking psychotropic drugs
Drug and smoking addiction
Pregnancy complications such as preeclampsia, bleeding, intrauterine death, preterm delivery
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Age
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From 18 years old to 40 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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Sample size
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Target sample size:
116
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The method of assigning the intervention to individuals is random and in the method of random permutation blocks with block size 6 (using the table related to random permutations) and with a ratio of 1: 1. The randomization list is prepared by a statistician. The codes assigned to the eligible individuals will be placed in sealed envelopes by an out-of-study person who is unaware of the research objectives and will be provided to the secretary of the clinic. They will not know who is in which group.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The codes assigned to the eligible individuals will be placed in sealed envelopes by an out-of-study person who is unaware of the research objectives and will be provided to the secretary of the clinic. They will not know who is in which group.
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Placebo
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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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2021-06-15, 1400/03/25
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Ethics committee reference number
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IR.AJUMS.REC.1400.192
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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F40
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ICD-10 code description
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Phobic anxiety disorders
Primary outcomes
1
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Description
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Fear of childbirth score in Vijma childbirth fear questionnaire
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Timepoint
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At the beginning of the study (before the intervention) with Vijma Maternity Fear Questionnaire version A and at the end of the intervention (first postpartum visit) with Vijama Maternity Fear Questionnaire version B
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Method of measurement
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Vijma Childbirth Fear Questionnaire version A and B
Intervention groups
1
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Description
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Intervention group: Tapping the parts of the face and body with the fingertips, which include: the beginning of the eyebrows (above the nose), the sides of the eyes (on the outer bone of the eye), the under eyes (on the cheeks and 2-3 cm Meters below the eye socket), under the lips (in the short distance between the nose and the upper lip), chin (in the middle of the distance between the chin and the lower lip), clavicle (from the U-shaped bone below the throat 2-3 cm down and 2-3 cm Meters to the sides) and armpits (10 cm below the armpits).
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Category
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Other
2
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Description
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Control group: This group also strikes with their fingers using false points, ie points other than the points of acupressure introduced.
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Category
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Placebo
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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Ahvaz 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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I do not have a plan at the moment
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available