Protocol summary
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Study aim
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To Determine The Effect Of Midwifery Counseling With Spiritual Approach In Improving Sleep Quality Among Pregnant Women
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Design
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The Present Study Is Phase 3 Of A Randomized Clinical Trial, Has A Control Group With Parallel Groups. That Will Be Performed On 40 Patients (20 Interventions And 20 Control Interventions). We Do Not Have Blinding. Eligible Women Will Be Selected By Convenience Sampling Method And Will Be Assigned To Two Intervention And Control Groups Using 4 Random Blocks.
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Settings and conduct
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The Research Setting Includes Health Centers Of Abhar City. For The Intervention Group, 8 Sessions Counseling With Spiritual Approach Will Be Held. The Control Group Will Be Received Routine Prenatal Care.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Gestational Age 16-20 weeks; Getting More Than 5 Point Based On The Pittsburgh Sleep Quality Index; Getting Score Less Than 22 Based On The 28-Items General Health Questionnaire
Exclusion Criteria: Having A Medical And Obstetric Complication; Taking Sleeping Pills; Having A Known Mental Disease
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Intervention groups
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The Intervention Group Will Be Received Counseling With Spiritual Approach At 20 Week Of Gestation. Spiritual Group Counseling Will Be Held In 8 Sessions, Twice Per A Week, Each Session For 45 To 60 Minutes.To Compile The Content Of The Sessions Bualehri's Book Has Been Used, which includes: Talking About The Concept Of Sleep, Sleep Quality, Changes In Sleep Patterns During Pregnancy.The Causes And Problems Of Insomnia. One's Attitude Towards Spiritual Issues, The Role Of God And Religion In Her Life. Sleep Health Education. Relaxation, Breathing Exercises With Focusing On Mentioning Allah and repeating it 10 to 15 times In a day.To Emphasis on Faith In God, Trust, Forgiveness, And Repentance In Relaxation And Controlling Of Insomnia Stimuli.
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Main outcome variables
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Sleep Quality
General information
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Reason for update
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The sampling date is before the confirmation date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150731023423N15
Registration date:
2020-06-24, 1399/04/04
Registration timing:
registered_while_recruiting
Last update:
2020-08-03, 1399/05/13
Update count:
1
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Registration date
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2020-06-24, 1399/04/04
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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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2020-06-24, 1399/04/04
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Expected recruitment end date
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2020-09-29, 1399/07/08
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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 Midwifery Counseling With spiritual approach In Improving The Sleep Quality Of Pregnant Women
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Public title
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The Effect Of Midwifery Counseling With Spiritual Approach In Improving The Sleep Quality Of Pregnant Women
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Gestational Age 20-16 weeks
The Desire To Participate In The Study
Getting More Than 5 Point Based On The Pittsburgh Sleep Quality Index
Getting Score Less Than 22 Based On The 28-Item General Health Questionnaire
Normal Pregnancy
Wanted Pregnancy
Exclusion criteria:
Having A Medical And Obstetric Complication
Taking Sleeping Pills
Having A Known Mental Disease
Participate In A Spiritual-Oriented Training Program
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Age
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From 18 years old to 35 years old
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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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Convenience Sampling Method will Be Employed to Select The Eligible Mothers.They Will Be Allocated Into The Two Groups (Intervention and Control) Based On The Four Block Design. In This Way, Six Possible Blocks Will Be Assigned To Group A (Intervention) And Group B (Control). Then, The Number Of Blocks Will Be Selected From The Random Number Table Until The Study Sample Size Will Be Reached. To Ensure The Concealment of The Sequence of Enrollment, We Will Be Used The Sequentially Numbered, Opaque Sealed Envelopes.
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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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2019-06-25, 1398/04/04
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Ethics committee reference number
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IR.ZUMS.REC.1398.153
Health conditions studied
1
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Description of health condition studied
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Sleep Quality
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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Severity Of Insomnia
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ICD-10 code
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ICD-10 code description
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3
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Description of health condition studied
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Spiritual Sxperience
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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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Sleep Quality
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Timepoint
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Before The Intervention, 28 And 36 Weeks Of Gestation
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Method of measurement
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Pittsburgh Sleep Quality questionnaire
2
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Description
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The Severity Of Insomnia
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Timepoint
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Before The Intervention, 28 And 36 Weeks Of Gestation
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Method of measurement
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Insomnia Severity Questionnaire
3
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Description
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Spiritual Experience
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Timepoint
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Before The Intervention, 28 And 36 Weeks Of Gestation
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Method of measurement
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The Daily Spiritual Experience Scale
Secondary outcomes
1
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Description
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The severity of insomnia
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Timepoint
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Before the intervention, week 28 and week 36 of pregnancy
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Method of measurement
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ISI Sleep Disorders Index Questionnaire
2
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Description
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Daily spiritual experiences
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Timepoint
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Before the intervention, week 28 and week 36 of pregnancy
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Method of measurement
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The scale of daily spiritual experiences (DSES)
Intervention groups
1
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Description
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Intervention group:The Intervention Group Will Be Received Counseling With Spiritual Approach At 20 Week Of Gestation. Spiritual Group Counseling Will Be Held In 8 Sessions, Twice Per A Week, Each Session For 45 To 60 Minutes.To Compile The Content Of The Sessions Bouleri's Book Has Been Used, Which Includes: Talking About The Concept Of Sleep, Sleep Quality, Changes In Sleep Patterns During Pregnancy.The Causes And Problems Of Insomnia. One's Attitude Towards Spiritual Issues, The Role Of God And Religion In Her Life. Sleep Health Education. Relaxation, Breathing Exercises With Focusing On Mentioning Allah And Repeating It 10 To 15 Times In A Day.To Emphasis On Faith In God, Trust, Forgiveness, And Repentance In Relaxation And Controlling Of Insomnia Stimuli.
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Category
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Prevention
2
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Description
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Control group: They Will Receive 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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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