Protocol summary
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Study aim
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The effect of counseling with spirituality-oriented approach on quality of life after childbirth in women with preeclampsia
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Design
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Phase 3 is a randomized controlled clinical trial with parallel groups that will be performed on 40 patients (20 intervention patients, 20 control patients). We do not have blindness. Eligible women will be selected by the available method and will be assigned to the intervention and control groups by the 4-item random block method using a random number table.
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Settings and conduct
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The research environment includes the postpartum ward of Ayatollah Mousavi Hospital in Zanjan and the study population including postpartum women with preeclampsia admitted to the ward by simple sampling method and then randomly assigned to the control and intervention groups in a block of 4.
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Participants/Inclusion and exclusion criteria
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Preeclampsia- Hospitalization less than 5 days-No other chronic diseases (diabetes - kidney disease - cancer)
Not having a known mental illness- Willingness to participate in the study-Having a delivery with a singleton pregnancy, without known neonatal abnormalities - Intrauterine death of the baby
Literacy for reading and writing-Score less than 22 based on the -GHQ-28 General Health Questionnaire
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Intervention groups
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The individual counseling intervention group with a spirituality-based approach based on Richards and Bergin's pattern protocol, will be held in 5 sessions. Three face-to-face counseling sessions for 45-60 minutes during hospital stay and two sessions of postpartum telephone counseling weekly after discharge. . The control group will receive routine care.
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Main outcome variables
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Quality of life, preeclampsia
General information
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Reason for update
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Updating sampling start date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150731023423N16
Registration date:
2020-10-01, 1399/07/10
Registration timing:
registered_while_recruiting
Last update:
2020-10-05, 1399/07/14
Update count:
1
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Registration date
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2020-10-01, 1399/07/10
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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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2020-10-01, 1399/07/10
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Expected recruitment end date
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2021-03-18, 1399/12/28
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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 counseling with spirituality-oriented approach on quality of life after childbirth in women with preeclampsia
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Public title
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The effect of spirituality counseling on the quality of life of preeclamptic 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:
- Preeclampsia - Hospitalization less than 5 days - No other concomitant chronic diseases (diabetes - Kidney disease - Cancer) - No known mental illness - Willingness to participate in the study - Having a delivery with a singleton pregnancy, withoabnormalities Known Infant - Intrauterine Infant Death -Literacy for reading and writing - Score less than 22 based on GHQ-28 General Health Questionnaire
- Hospitalization less than 5 days
- No other concomitant chronic diseases (diabetes - Kidney disease - Cancer)
- No known mental illness
- Willingness to participate in the study
- Having a delivery with a singleton pregnancy, withoabnormalities Known Infant - Intrauterine Infant Death
-Literacy for reading and writing
- Score less than 22 based on GHQ-28 General Health Questionnaire
Exclusion criteria:
Having postpartum complications (bleeding, infection, etc.)
Infant death
Reluctance to continue cooperation in the study
Changing the treatment process (eg transfer to the intensive care unit)
Failure to answer a phone call during the follow-up period
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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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3
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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:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Eligible samples will be selected by convenience sampling method and then randomly assigned to 4 control and intervention groups of 4 blocks. For the intervention group, one-on-one counseling with a spirituality-based approach based on the Richards and Bergin's pattern protocol will be held in 5 sessions. Three face-to-face counseling sessions for 45-60 minutes during hospital stay and two sessions of postpartum telephone counseling weekly after discharge. (39, 43). The control group will receive routine care. Data collection tools include demographic characteristics questionnaire, postpartum quality of life questionnaire, general health questionnaire: GHQ and DSES questionnaire (daily spiritual experiences) which in two stages before the intervention and 6 weeks after the end of counseling sessions by research units. Complete and will be analyzed using SPSS statistical software version 20 and statistical methods of chi-square, independent t-test and paired t-test, MANCOVA statistical methods and multivariate analysis of variance MANOVA in case of abnormal distribution of non-parametric tests The equivalent will be used.
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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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2019-12-10, 1398/09/19
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Ethics committee reference number
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IR.ZUMS.REC.1398.376
Health conditions studied
1
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Description of health condition studied
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Quality of life after childbirth in women with preeclampsia
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ICD-10 code
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ICD-10 code description
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Primary outcomes
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Description
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The effect of spirituality-oriented counseling on quality of life after childbirth in women with preeclampsia
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Timepoint
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Three sessions of spiritual counseling modeled on Richards and Bergin, in person for 45-60 minutes during hospital stay and two sessions of telephone counseling weekly after discharge
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Method of measurement
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, Postpartum Quality of Life Questionnaire, General Health Questionnaire: GHQ, DSES Questionnaire (Daily Spiritual Experiences)
2
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Description
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Quality of life after childbirth in women with preeclampsia
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Timepoint
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Three sessions of spiritual counseling modeled on Richards and Bergin, in person for 45-60 minutes during hospital stay and two sessions of telephone counseling weekly after discharge
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Method of measurement
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Postpartum Quality of Life Questionnaire, General Health Questionnaire: GHQ, DSES Questionnaire (Daily Spiritual Experiences)
Secondary outcomes
1
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Description
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Quality of Life
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Timepoint
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In two stages before the intervention and 6 weeks after the end of the consultation sessions by the research units
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Method of measurement
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General Health Questionnaire: GHQ, DSES Questionnaire (Daily Spiritual Experiences)
2
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Description
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Quality of life after childbirth in women with preeclampsia
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Timepoint
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In two stages before the intervention and 6 weeks after the end of the consultation sessions by the research units
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Method of measurement
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Postpartum Quality of Life Questionnaire
Intervention groups
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Description
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Intervention group: The intervention group will receive three face-to-face counseling sessions for 45-60 minutes during hospitalization and two sessions of telephone postpartum counseling weekly after discharge. The contents of the sessions include introducing oneself and getting to know the patient, expressing the goals of the project, creating empathy, talking about the disease, assessing the mental condition and physical condition, paying attention to the patient's attitude towards the disease, physical health, negative emotions, stress and worries and strategies to deal with them. About the concept of quality of life, dimensions of quality of life and the importance of self-awareness, belief, values in life. Talking about one's expectations of life, community, values, attitude towards spiritual issues, the role of God and religion in life Talk about Positive experiences of the patient about the use of spiritual issues in dealing with stressful situations in life Recalling the role of women in creation, spiritual aspects of pregnancy and childbirth, maternal role from the perspective of Islam, review of the previous session With breathing exercises and repeating it 10 to 15 times a day, it is recommended to listen to the music of nature, the sound of the Quran during the day, the role of charity, trust, recourse, patience, charity (kindness and forgiveness) and focusing on God's blessings in reducing stress. Pre-assessment sessions on a person's mood, attitude and beliefs The role of gratitude to God in enduring hardships, increasing hope and self-confidence in adjustment and accepting the position of the role of reading the Bible in patients' comfort, the story of religious people, encouraging patients to talk to people who make them feel positive, increasing intimacy with spouse Using their participation in life-centered counseling responsibilities in telephone follow-up sessions will include reviewing and recalling the content of face-to-face counseling sessions. Including trust, empathy and honesty between midwives and mothers to communicate properly during the sessions.
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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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No
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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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1
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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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Possibility of Dissatisfaction of 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