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General information
2020-05-28, 1399/03/08
2020-06-24, 1399/04/04
2020-0506-2824 00:00:00
empty
The sampling date is before the confirmation date
The sampling date is before the confirmation date
empty
تاریخ نمونه گیری قبل تاریخ تایید است
تاریخ نمونه گیری قبل تاریخ تایید است
Recruitment centers
#1
Name of recruitment center - English: Abhar County Health Centers - Clinic No. 5 - Shahrivar 17 Clinic - Hossein Abad Clinic - Shenat Clin
Name of recruitment center - Persian: مراکز بهداشتی درمانی شهرستان ابهر- درمانگاه شماره 5- درمانگاه 17 شهریور- درمانگاه حسین آباد- درمانگا
Full name of responsible person - English: Nahid Moradi
Full name of responsible person - Persian: ناهید مرادی
Street address - English: Zanjan - Abhar Qaleh Tappeh Abhar Health Center
Street address - Persian: زنجان- ابهر قلعه تپه مرکز بهداشت شهرستان ابهر
City - English: Zanjan
City - Persian: زنجان
Province: Zanjan
Country: Iran (Islamic Republic of)
Postal code: 4515613191
Phone: +98 24 3524 2075
Fax:
Email: midwifmoradi@gmail.com
Web page address:
Name of recruitment center - English: Health Centers Of Abhar City,Zanjan, Iran
Name of recruitment center - Persian: مراکز بهداشتی شهرستان ابهر، زنجان، ایران
Full name of responsible person - English: Nahid Moradi
Full name of responsible person - Persian: ناهید مرادی
Street address - English: Zanjan - Abhar Qaleh Tappeh Abhar Health Center
Street address - Persian: زنجان- ابهر قلعه تپه مرکز بهداشت شهرستان ابهر
City - English: Zanjan
City - Persian: زنجان
Province: Zanjan
Country: Iran (Islamic Republic of)
Postal code: 4515613191
Phone: +98 24 3524 2075
Fax:
Email: midwifmoradi@gmail.com
Web page address:
Name of recruitment center - English: Abhar County Health Centers - Clinic No. 5 - Shahrivar 17 Clinic - Hossein Abad Clinic - Shenat ClinOf Abhar City,Zanjan, Iran Name of recruitment center - Persian: مراکز بهداشتی درمانی شهرستان ابهر- درمانگاه شماره 5- درمانگاه 17 شهریور- درمانگاه حسین آباد- درمانگا، زنجان، ایران Full name of responsible person - English: Nahid Moradi Full name of responsible person - Persian: ناهید مرادی Street address - English: Zanjan - Abhar Qaleh Tappeh Abhar Health Center Street address - Persian: زنجان- ابهر قلعه تپه مرکز بهداشت شهرستان ابهر City - English: Zanjan City - Persian: زنجان Province: Zanjan Country: Iran (Islamic Republic of) Postal code: 4515613191 Phone: +98 24 3524 2075 Fax: Email: midwifmoradi@gmail.com Web page address:
Protocol summary
Study aim
To Determine The Effect Of Midwifery Counseling With Spiritual Approach In Improving Sleep Quality Among Pregnant Women
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Sleep Quality
General information
Reason for update
The sampling date is before the confirmation date
Acronym
IRCT registration information
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
Registration date
2020-06-24, 1399/04/04
Registrant information
Name
Azam Maleki
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3345 4264
Email address
malekia@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-24, 1399/04/04
Expected recruitment end date
2020-09-29, 1399/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Midwifery Counseling With spiritual approach In Improving The Sleep Quality Of Pregnant Women
Public title
The Effect Of Midwifery Counseling With Spiritual Approach In Improving The Sleep Quality Of Pregnant Women
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Zanjan University of Medical Sciences
Street address
Zanjan, Azadi Blvd., Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.ZUMS.REC.1398.153
Health conditions studied
1
Description of health condition studied
Sleep Quality
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Severity Of Insomnia
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Spiritual Sxperience
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep Quality
Timepoint
Before The Intervention, 28 And 36 Weeks Of Gestation
Method of measurement
Pittsburgh Sleep Quality questionnaire
2
Description
The Severity Of Insomnia
Timepoint
Before The Intervention, 28 And 36 Weeks Of Gestation
Method of measurement
Insomnia Severity Questionnaire
3
Description
Spiritual Experience
Timepoint
Before The Intervention, 28 And 36 Weeks Of Gestation
Method of measurement
The Daily Spiritual Experience Scale
Secondary outcomes
1
Description
The severity of insomnia
Timepoint
Before the intervention, week 28 and week 36 of pregnancy
Method of measurement
ISI Sleep Disorders Index Questionnaire
2
Description
Daily spiritual experiences
Timepoint
Before the intervention, week 28 and week 36 of pregnancy
Method of measurement
The scale of daily spiritual experiences (DSES)
Intervention groups
1
Description
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.
Category
Prevention
2
Description
Control group: They Will Receive Routine Prenatal care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers Of Abhar City,Zanjan, Iran
Full name of responsible person
Nahid Moradi
Street address
Zanjan - Abhar Qaleh Tappeh Abhar Health Center
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3524 2075
Email
midwifmoradi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
Zanjan
City
Abhar
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3534 2075
Email
midwifmoradi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nahid Moradi
Position
Msc Student in Midwifery Counseling
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University Of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3345 7707
Email
midwifmoradi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Maleki Azam
Position
PhD in Maternal & Child Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University Of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24334206519
Email
Makekia@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Maleki Azam
Position
PhD in Maternal & Child Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University Of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24334206519
Email
Malekia@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD