Protocol summary
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Study aim
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The Effectiveness of Spirituality Counseling on Coping with Pregnancy and Quality of Life in First Time Pregnant Women
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Design
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In A Randomized Clinical Trial With A Control Group, 60 of Eligible Pregnant Women will be Participated in The Study. The Intervention Group will be Received 8 Sessions Counseling and Control Group will be Received Routine Care . Both Groups will be Followed for Two Month. The Outcome of The Study will be Determined in Two Steps Before and Two Month After The Last Consultation.
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Settings and conduct
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Sampling will be Done From Three Health Centers of Zanjan City. Firstly, 60 Eligible Women will be Selected by Convenience Method and Then will be Allocated to The Intervention and Control Groups based on The Four Blocks That are Extracted by Statistical Software. We do not have Blindness in This Study.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria Include: Desire to Participate in The Study; Planned Pregnancy; First Time Pregnancy; Gestational Age 20-24 Weeks; Lack of History of Known Mental and Physical Illnesses; Low Risk and Uncomplicated Pregnancy; Singleton Pregnancy; Getting Score From 18 to 36 by Cohen Perceived Stress Questionnaire; Getting Score Lower Than 10 by Edinburgh Depression Inventory. Exclusion Criteria Include: Unwilling to Participate in The Study; The Absence of More Than Two Sessions
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Intervention groups
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The intervention group, in addition to the Pregnancy Preparation classes, will receive group counseling for the spirituality-centered and control groups only for the preparation of maternity wards.
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Main outcome variables
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Quality of Life and Coping with First Pregnancy
General information
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Reason for update
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Hello, The Start Date of sampling has been Incorrectly Entered and The Status of The Code has been Retrospective. Please Help to Resolve the problem.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150731023423N12
Registration date:
2018-11-06, 1397/08/15
Registration timing:
prospective
Last update:
2020-05-19, 1399/02/30
Update count:
1
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Registration date
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2018-11-06, 1397/08/15
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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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2018-11-11, 1397/08/20
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Expected recruitment end date
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2019-02-22, 1397/12/03
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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 Spirituality Counseling on Coping with Pregnancy and Quality of Life in First Time Pregnant Women
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Public title
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The Effectiveness of Spirituality Counseling on Coping with Pregnancy and Quality of Life in First Time Pregnant Women
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Desire to Participate in The Study
Planned Pregnancy
First Time Pregnancy
Gestational Age 20-24 Weeks
Lack of History of Known Mental and Physical Illnesses
Low Risk and Uncomplicated Pregnancy
Singleton Pregnancy
Getting Score From 18 to 36 by Cohen Perceived Stress Questionnaire
Getting Score Lower Than 10 by Edinburgh Depression Inventory
Exclusion criteria:
Unwilling to Participate in The Study
The Absence of More Than Two Sessions consultaion
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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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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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Eligible Women will be Selected Using The Convenience Sampling Method and They will be Randomly Allocated to The Intervention and The Control Groups using Statistical software Randomized 4-Block method.
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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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2018-05-28, 1397/03/07
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Ethics committee reference number
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IR.ZUMS.REC.1397.024
Health conditions studied
1
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Description of health condition studied
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Quality of Life, Coping With Pregnancy
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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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Quality of life
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Timepoint
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Before and Two Months After The Last Session of Consultation
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Method of measurement
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Quality of Life Questionnaire
Secondary outcomes
1
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Description
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Copy With Pregnancy
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Timepoint
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Before and Two Months After The Last Session of Consultation
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Method of measurement
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Coping With Pregnancy Questionnaire
Intervention groups
1
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Description
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Participants in the intervention group will receive 8 group counseling sessions based on bipartite duality and 45 minutes per session for routine nursing care. The length of a one-month period and the content of the sessions include titles of forgiveness, repentance, meditation, the effect of the Qur'an, and authority on the birth and the fetus.
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Category
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Prevention
2
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Description
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Control group: Control group: The control group is the first 30 pregnant women attending routine childbirth classes, and no intervention by the investigator is applied to this group.
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Category
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Prevention
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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Zanjan 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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Dissatisfaction participants
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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