The effect of participation in the oral-pharyngeal administration of colostrum on anxiety of mothers of preterm infants admitted to neonatal intensive care unit
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Protocol summary
Randomized clinical trial, sample size=148
Randomized clinical trial, The sample size is 148 people, The random list of people is prepared through the website http://randomisation.ir.
Randomized clinical trial, The sample size= is 148 people, The random list of people is prepared through the website http://randomisation.ir.
کارآزمایی بالینی تصادفی ، حجم نمونه=148
کارآزمایی بالینی تصادفی، حجم نمونه 148 نفر، لیست تصادفی افراد از طریق سایت http://randomisation.ir تهیه می شود.
کارآزمایی بالینی تصادفی، حجم نمونه=148 نفر، لیست تصادفی افراد از طریق سایت http://randomisation.ir تهیه می شود.
anxiety in mothers of preterm infants
Anxiety in mothers of preterm infants
anxietyAnxiety in mothers of preterm infants
General information
ابتلای مادر به اختلالات روانشناختی نیازمند مصرف دارو براساس خودگزارشی مادر
سابقه سوء استفاده از مواد مخدر و روان گردان
جراحی یا مشکلات پستانی نظیر آبسه، نیپل وارونه، ماستیت یا سرطان
دارا بودن بیماری هایی مغایر با شیردهی مثل ایدز، سل ریوی فعال
بروز حوادث استرس زا در طول مطالعه
بستری شدن مادر پس از زایمان در بخش هایی غیر از پست پارتوم
نداشتن خونریزی داخل بطنی درجه 3 و4
عدم وجود PH کمتر از 6 در دقیقه پنجم بعد از تولد
نبود ناهنجاری در نوزاد براساس مدارک پزشکی
ابتلای مادر به اختلالات روانشناختی نیازمند مصرف دارو براساس خودگزارشی مادر
سابقه سوء استفاده از مواد مخدر و روان گردان
جراحی یا مشکلات پستانی نظیر آبسه، نیپل وارونه، ماستیت یا سرطان
دارا بودن بیماری هایی مغایر با شیردهی مثل ایدز، سل ریوی فعال
بروز حوادث استرس زا در طول مطالعه
بستری شدن مادر پس از زایمان در بخش هایی غیر از پست پارتوم
نداشتن خونریزی داخل بطنی درجه 3 و 4
عدم وجود PH کمتر از 6 در دقیقه پنجم بعد از تولد
نبود ناهنجاری در نوزاد براساس مدارک پزشکی
ابتلای مادر به اختلالات روانشناختی نیازمند مصرف دارو براساس خودگزارشی مادر سابقه سوء استفاده از مواد مخدر و روان گردان جراحی یا مشکلات پستانی نظیر آبسه، نیپل وارونه، ماستیت یا سرطان دارا بودن بیماری هایی مغایر با شیردهی مثل ایدز، سل ریوی فعال بروز حوادث استرس زا در طول مطالعه بستری شدن مادر پس از زایمان در بخش هایی غیر از پست پارتوم نداشتن خونریزی داخل بطنی درجه 3 و4و 4 عدم وجود PH کمتر از 6 در دقیقه پنجم بعد از تولد نبود ناهنجاری در نوزاد براساس مدارک پزشکی
Eligible samples will be continuously included in the study, then the allocation will be done in two groups of test and control randomly using the 4 block method with placement. The random list of people is prepared through the website http://randimisation.ir
Eligible samples will be continuously included in the study, then the allocation will be done in two groups of test and control randomly using the 4-block method with placement. The random list of people is prepared through the website http://randomisation.ir.
Eligible samples will be continuously included in the study, then the allocation will be done in two groups of test and control randomly using the 4-block method with placement. The random list of people is prepared through the website http://randimisation.irrandomisation.ir.
نمونه های واجد شرایط به صورت مستمر وارد مطالعه خواهند شد، سپس تخصیص در دو گروه آزمون و کنترل به شكل تصادفی با استفاده از روش بلوک 4 تایی همراه با جای گذاری انجام خواهد شد. لیست تصادفی افراد از طریق سایت http://randimisation.ir تهیه می شود.
نمونه های واجد شرایط به صورت مستمر وارد مطالعه خواهند شد، سپس تخصیص در دو گروه آزمون و کنترل به شكل تصادفی با استفاده از روش بلوک 4 تایی همراه با جای گذاری انجام خواهد شد. لیست تصادفی افراد از طریق سایت http://randomisation.ir تهیه می شود.
نمونه های واجد شرایط به صورت مستمر وارد مطالعه خواهند شد، سپس تخصیص در دو گروه آزمون و کنترل به شكل تصادفی با استفاده از روش بلوک 4 تایی همراه با جای گذاری انجام خواهد شد. لیست تصادفی افراد از طریق سایت http://randimisation.irrandomisation.ir تهیه می شود.
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyedeh saeedeh Mousavi
Full name of responsible person - Persian: سیده سعیده موسوی
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 53
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
Street address - Persian: تهران -خیابان ولیعصر- بالاتر از میدان ونک- خیابان رشید یاسمی- گروه مامایی دانشکده پرستاری و مامایی علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1996713883
Phone: +98 21 4365 1807
Mobile: +98 912 413 3442
Fax:
Email: mousavi.ss@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyedeh saeedeh Mousavi
Full name of responsible person - Persian: سیده سعیده موسوی
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 53
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
Street address - Persian: تهران، خیابان ولیعصر، بالاتر از میدان ونک، خیابان رشید یاسمی، گروه مامایی دانشکده پرستاری و مامایی علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1996713883
Phone: +98 21 4365 1807
Mobile: +98 912 413 3442
Fax:
Email: mousavi.ss@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Seyedeh saeedeh Mousavi Full name of responsible person - Persian: سیده سعیده موسوی Position - English: Associate professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 53 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street Street address - Persian: تهران -، خیابان ولیعصر-، بالاتر از میدان ونک-، خیابان رشید یاسمی-، گروه مامایی دانشکده پرستاری و مامایی علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1996713883 Phone: +98 21 4365 1807 Mobile: +98 912 413 3442 Fax: Email: mousavi.ss@iums.ac.ir Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyedeh saeedeh Mousavi
Full name of responsible person - Persian: سیده سعیده موسوی
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 53
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
Street address - Persian: خیابان ولی عصر، بالاتر از میدان ونک، خیابان رشید یاسمی دانشکده پرستاری و مامایی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1996713883
Phone: +98 21 4365 1807
Mobile: +98 912 413 3442
Fax:
Email: mousavi.ss@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyedeh saeedeh Mousavi
Full name of responsible person - Persian: سیده سعیده موسوی
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 53
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
Street address - Persian: خیابان ولی عصر، بالاتر از میدان ونک، خیابان رشید یاسمی، دانشکده پرستاری و مامایی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1996713883
Phone: +98 21 4365 1807
Mobile: +98 912 413 3442
Fax:
Email: mousavi.ss@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Seyedeh saeedeh Mousavi Full name of responsible person - Persian: سیده سعیده موسوی Position - English: Associate professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 53 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street Street address - Persian: خیابان ولی عصر، بالاتر از میدان ونک، خیابان رشید یاسمی، دانشکده پرستاری و مامایی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1996713883 Phone: +98 21 4365 1807 Mobile: +98 912 413 3442 Fax: Email: mousavi.ss@iums.ac.ir Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyedeh saeedeh Mousavi
Full name of responsible person - Persian: سیده سعیده موسوی
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 53
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
Street address - Persian: خیابان ولی عصر، بالاتر از میدان ونک، خیابان رشید یاسمی دانشکده پرستاری و مامایی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1996713883
Phone: +98 21 4365 1807
Mobile: +98 912 413 3442
Fax:
Email: mousavi.ss@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyedeh saeedeh Mousavi
Full name of responsible person - Persian: سیده سعیده موسوی
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 53
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
Street address - Persian: خیابان ولی عصر، بالاتر از میدان ونک، خیابان رشید یاسمی، دانشکده پرستاری و مامایی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1996713883
Phone: +98 21 4365 1807
Mobile: +98 912 413 3442
Fax:
Email: mousavi.ss@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Seyedeh saeedeh Mousavi Full name of responsible person - Persian: سیده سعیده موسوی Position - English: Associate professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 53 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street Street address - Persian: خیابان ولی عصر، بالاتر از میدان ونک، خیابان رشید یاسمی، دانشکده پرستاری و مامایی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1996713883 Phone: +98 21 4365 1807 Mobile: +98 912 413 3442 Fax: Email: mousavi.ss@iums.ac.ir Web page address:
Protocol summary
Study aim
Determining the effect of participation in the oral-pharyngeal administration of colostrum on the anxiety of mothers of premature babies hospitalized in the neonatal intensive care unit
Design
Randomized clinical trial, The sample size is 148 people, The random list of people is prepared through the website http://randomisation.ir.
Settings and conduct
This research is a clinical trial that is conducted in Shahid Akbarabadi State Hospital in Tehran. At the beginning, the researcher invites eligible research units to cooperate in the study. If the research units are willing to participate in this study, they will be randomly divided into two intervention and control groups. Before and 24 hours after the intervention, the situational trait anxiety questionnaire is completed by the mothers of both groups.
Participants/Inclusion and exclusion criteria
Mothers of premature babies and their babies
Intervention groups
During the first 24 hours after giving birth, the mothers of the intervention group deliver their expressed milk to the researcher three times a day every 4 hours during the prescribed time in the morning and evening shifts for 48 hours, and the researcher injects the milk with a 1 ml syringe without a needle. It is given to the baby three times a day, in the presence of the mother and under the supervision of a neonatologist. In this way, the tip of the syringe is placed in the baby's mouth along the right buccal mucosa towards the oropharynx and the volume of 0.1 ml is prescribed, and without removing the syringe from the baby's mouth, 0.1 ml is also administered in the left buccal. The mentioned is repeated. A total of 0.2 ml is prescribed in each session. Mothers in the control group are not given milk to feed their babies, and according to the department's routine, when the doctor orders them to start breastfeeding, they express their milk and deliver it to the neonatal intensive care unit.
Main outcome variables
Anxiety in mothers of preterm infants
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200120046200N3
Registration date:2022-11-14, 1401/08/23
Registration timing:registered_while_recruiting
Last update:2023-02-07, 1401/11/18
Update count:2
Registration date
2022-11-14, 1401/08/23
Registrant information
Name
Seyedeh saeedeh Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1807
Email address
mousavi.ss@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of participation in the oral-pharyngeal administration of colostrum on anxiety of mothers of preterm infants admitted to neonatal intensive care unit
Public title
The effect of participation in the oral-pharyngeal administration of colostrum on anxiety of mothers of preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 18 years and above
Willingness to breastfeed
Understanding and speaking ability in Persian language
Willing to manually express milk or use of a manual or electric breast pump in the first 24 hours after delivery
mother's presence in the hospital during the study period
Gestational age less than 32 weeks or birth weight less than 1500 grams
Being NPO for infant
Stable vital signs for infant
Exclusion criteria:
Mother's suffering from psychological disorders requiring medication based on mother's self-report
History of drug and psychoactive abuse
Surgery or breast problems such as abscess, inverted nipple, mastitis or cancer
Having diseases contrary to breastfeeding such as AIDS, active pulmonary tuberculosis
Occurrence of stressful events during the study period
Hospitalization of the mother after delivery in departments other than postpartum
No grade 3 and 4 intraventricular hemorrhage
Absence of pH less than 6 in the fifth minute after birth
Absence of abnormalities in the infant based on medical records
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
148
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible samples will be continuously included in the study, then the allocation will be done in two groups of test and control randomly using the 4-block method with placement. The random list of people is prepared through the website http://randomisation.ir.
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 Iran University of Medical Sciences
Street address
Fifth floor, Headquarters., Iran University of Medical Sciences., Hemmat Highway between Chamran and Sheikh Fazlullah
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-10-04, 1401/07/12
Ethics committee reference number
IR.IUMS.REC.1401.555
Health conditions studied
1
Description of health condition studied
The effect of participation in the oral-pharyngeal administration of colostrum on the anxiety of mothers of premature babies hospitalized in the neonatal intensive care unit
ICD-10 code
Z63.7
ICD-10 code description
Other stressful life events affecting family and household
Primary outcomes
1
Description
Maternal anxiety
Timepoint
Before the intervention, 24 hours after the intervention
Method of measurement
State Trait Anxiety Inventory(STAI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: During the first 24 hours after giving birth, the mothers of the test group deliver their expressed milk to the researcher three times a day every 4 hours during the prescribed time in the morning and evening shifts for 48 hours, and the researcher injects the expressed colostrum with a 1 ml syringe, without The head of the needle is given to the baby three times a day, in the presence of the mother and under the supervision of a newborn doctor. In this way, the tip of the syringe is placed in the baby's mouth along the right buccal mucosa and is directed to the oropharynx, and the volume of 0.1 ml is prescribed, and without removing the syringe from inside the baby's mouth, the left buccal is also 0.1 ml. ml is repeated in the mentioned method. A total of 0.2 ml is prescribed in each session. Mothers in the control group do not receive milk to feed the baby, and they express their milk and deliver it to the neonatal intensive care unit according to the department's routine when the doctor orders to start breastfeeding and feeding the baby.
Category
N/A
2
Description
Control group: Mothers in the control group are not given milk to feed the baby, and according to the department's routine, when the doctor orders to start breastfeeding and feeding the baby, they express their milk and deliver it to the neonatal intensive care unit.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbarabadi Hospital
Full name of responsible person
Elham Rohani
Street address
Ferdous Garden Station, Molvi Street
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem mousavizade
Street address
Area Two, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 9024 6650
Email
mousavizadeh.k@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Seyedeh saeedeh Mousavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1807
Email
mousavi.ss@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh saeedeh Mousavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1807
Email
mousavi.ss@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh saeedeh Mousavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1807
Email
mousavi.ss@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document