Protocol summary
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Study aim
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Determining the effect of social media-based education on postpartum body image in Primiparous women
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Design
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The trial consisted of two groups of control and intervention, in parallel and one-way blind and random.
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Settings and conduct
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health centers in Sari.
Randomization into 2 intervention and control groups.
8 intervention sessions are performed twice a week for the intervention group. The evaluation is performed in 3 times of before intervention, immediately and one month after the intervention.
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Participants/Inclusion and exclusion criteria
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being primiparous, 3 to 12 weeks after delivery, not having any mental illness and hospitalization history , not having body-dysmorphic disorder, ability to use social networks, having a smart phone, internet access and living in Sari, couples not addicted to addictive substances , being monogamy, not taking drugs that affect sexual function, not attending training programs in more than two programs, see a psychiatrist or use Psychiatric medication during the intervention and happen unfortunate event such as loss of Relatives during the intervention.
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Intervention groups
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A social media-based training program will be conducted in the intervention group in addition to postnatal care. These interventions are providing training related to body image in the form of videos, photos and educational texts with the aim of improving women's body image through social media programs by creating a virtual group and using it at home for the convenience of women. The researchers will be placed in 8 training sessions in this group during a month. for control group, irrelevant content with body image is placed in a virtual group for one month.
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Main outcome variables
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body image
General information
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Reason for update
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To increase the accuracy of the study and to blind the study, we prepare non-body image related materials and provide them to the intervention group during 8 sessions.
The educational topics of the control group include: child care, child growth, complementary nutrition of children
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150608022609N9
Registration date:
2020-08-12, 1399/05/22
Registration timing:
prospective
Last update:
2021-04-17, 1400/01/28
Update count:
1
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Registration date
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2020-08-12, 1399/05/22
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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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2020-08-15, 1399/05/25
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Expected recruitment end date
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2020-09-15, 1399/06/25
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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 Social Media-based Education On Postpartum Body Image in Primiparous Women (based on Dr. Cash eight- steps program to improve Body image)
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Public title
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The Effect of Social Media-based Education On Postpartum Body Image
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Willingness to participate in the study
Being Primiparous
3 to 12 weeks have passed since delivery
Ability to use social networks
Having a smart phone
Having Internet access
Living in Sari city
Monogamy
Exclusion criteria:
Having any mental illness and history of hospitalization (according to the client report)
having body dysmorphic disorder (according to the diagnostic criteria for body dysmorphic disorder DSM5)
Couples are addicted to drugs such as cigarettes, alcohol, morphine, codeine, hydrocodone, oxycodone, marijuana, heroin and cocaine
Useing drugs that affect sexual function such as commonly used psychiatric drugs and anti hypertensive drugs and chemotherapy drugs
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Age
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No age limit
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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:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The list of all eligible women will be obtained from selected health centers in Sari city. At this stage, after identifying eligible Primiparous women, they will be selected to enter the study as available in health centers and using random allocation method by using computer program Random block permutation in order to select individuals in the intervention and control groups.Women in both groups will be matched in terms of body mass index and type of delivery.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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After randomizing the participants into two groups( intervention and control) , both groups are entered in a virtual group and educational materials related to each group are placed in that group.
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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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2020-08-15, 1399/05/25
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Ethics committee reference number
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IR.MAZUMS.REC.1399.507
Health conditions studied
1
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Description of health condition studied
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body image
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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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body image
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Timepoint
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Before intervention, immediately after the intervention and a month later
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Method of measurement
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Multidimensional Body-Self Relations Questionnaire
Secondary outcomes
1
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Description
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Women's Sexual quality of life
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Timepoint
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Before intervention, immediately after the intervention and a month later
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Method of measurement
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Women's Sexual quality of life Questionnaire
2
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Description
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Women's Sexual Satisfaction
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Timepoint
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Before intervention, immediately after the intervention and a month later
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Method of measurement
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Multidimensional Sexual Satisfaction Scale for Women
3
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Description
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Women's image from their genitals
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Timepoint
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Before intervention, immediately after the intervention and a month later
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Method of measurement
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Women's image from their genitals questionnaire
Intervention groups
1
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Description
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Intervention group: After the pre-test, an educational intervention program based on social networks will be performed in the intervention group in addition to postnatal care. These interventions are the same as providing training related to body image in the form of videos and photos and text and audio educational messages with the aim of improving women's body image through social media programs by creating a virtual group and using it at home for women's comfort. In this way, the women of the intervention group become members of a virtual group and the educational content prepared by the researchers will be included in 8 training sessions in this group during a month. And topics such as physical and psychological consequences of childbirth, strengthening self-confidence and self-esteem, creating a positive feeling and strategies to improve body image along with homework to express the feelings and thoughts of women, which is designed based on Dr.Cash eight steps to improve body image.These eight steps will be to try to change the unpleasant body image and enjoy our acceptance. The first version of this program was released in 1991 and has been changed and supplemented over the years with expert opinions. The presence of women in the created group will be examined and will be followed by determining a specific time, the assignments intended for each session will be checked in the next session in the same group.
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Category
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Other
2
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Description
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Control group: After the pre-test, in addition to postnatal care, information related to child health, child care, child growth and complementary nutrition will be provided to women in a virtual group for one month during eight training sessions.
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Category
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Other
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