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The effect of mental relaxation technique on self –efficacy, breastfeeding sufficiency and performance of primiparous women

Protocol summary

Study aim
Determining the effect of mental relaxation technique on self-efficacy, adequacy and breastfeeding performance of primiparous women.
Design
A clinical trial with a control group, a blind strain, randomized, on 60 patients, rand function of Excel software was used for randomization.
Settings and conduct
The present study on sedation in lactating primiparous women in Talash city is a single-blind randomized clinical trial with blinding of the participants by block randomization method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being Iranian and living in Talesh city, having a pregnancy file in one of the comprehensive health centers in Talesh city health and treatment center, possessing elementary literacy, pregnancy age 30-32 weeks, being primiparous , no abuse of drugs, tobacco and alcohol, no disease or any disorder that prohibits breastfeeding, low-risk pregnancy and no chronic physical or mental debilitating diseases. Maternal and infant discharge criteria: The strong unwillingness of the mother to breastfeed, occurrence of mental or physical disorders that disrupt or prohibit the continuation of the breastfeeding, unwillingness to continue participating in the study or his simultaneous participation in another research, performing body relaxation exercises and mental imagery for less than 60 days, simultaneous and daily use of milk-increasing drugs, giving birth before 37 weeks of pregnancy, - hospitalization of the baby in the NICU, any abnormality of the jaw and A baby's face that interferes with the baby's natural breastfeeding, preterm birth.
Intervention groups
The intervention group: received trainings on relaxation and guided mental imagery, and the control group received only the usual breastfeeding trainings.
Main outcome variables
Breastfeeding self-efficacy; Breastfeeding performance; Adequacy of breastfeeding; Exclusive feeding

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231028059885N1
Registration date: 2024-01-27, 1402/11/07
Registration timing: registered_while_recruiting

Last update: 2024-01-27, 1402/11/07
Update count: 0
Registration date
2024-01-27, 1402/11/07
Registrant information
Name
Noosha Farzaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4423 8815
Email address
nooshafarzaie2023@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-16, 1402/09/25
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mental relaxation technique on self –efficacy, breastfeeding sufficiency and performance of primiparous women
Public title
The effect of mental relaxation technique on self –efficacy, breastfeeding sufficiency and performance of primiparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian and resident of Talesh city Having a pregnancy record in one of the comprehensive health centers or urban health centers covered by the health and treatment center of Talash city Elementary school Gestational age 30-32 weeks Nulliparous singleton pregnancy No abuse of drugs, tobacco and alcohol Not having diseases or any disorders that prohibit breastfeeding such as HIV/AIDS,Active Genital Herpes, Active untreated tuberculosis in the mother, or Breast abscess, Extensive breast burn or any abnormality that makes it difficult to breastfeed. Low-risk pregnancy and the mother's absence of chronic physical or mental debilitating diseases requiring medical treatment according to the doctor's opinion.
Exclusion criteria:
Mother's strong unwillingness to breastfeed after delivery Occurrence of mental or physical disorders diagnosed by the doctor during the implementation of the study, which requires referral and necessary medical/surgical interventions that disrupt or prohibit the continuation of the breastfeeding process. Unwillingness to continue participating in the study or her simultaneous participation in another research with similar educational interventions Performing relaxation exercises and mental imagery for less than 60 days Simultaneous and daily use of milk-enhancing drugs Delivery before the 37th week of pregnancy (in this case, it is reported as perinatal outcomes) Admission of the baby to the NICU Any abnormality of the baby's jaw and face that interferes with the baby's natural breastfeeding Preterm birthday Absence or development of gagging and sucking reflexes up to 3-5 days
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants do not know which group they belong to and this study is a blind strain
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commite of Shahid Beheshti University of Medical Sciences
Street address
Nursing and Midwifery Faculties of Shahid Beheshti University of Medical Sciences, In front of Shahid Rajaei Heart Hospital, Hashemi Rafsanjani Blv., Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2023-06-05, 1402/03/15
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.073

Health conditions studied

1

Description of health condition studied
Self-efficacy, adequacy and performance of breastfeeding
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Breastfeeding self-efficacy
Timepoint
The beginning of the study, the third, 15th and 60th day after delivery.
Method of measurement
Abbreviated Breastfeeding Self-Efficacy Questionnaire

2

Description
Lactation performance
Timepoint
The beginning of the study, the third, 15th and 60th day after delivery.
Method of measurement
Breastfeeding performance checklist

3

Description
Adequacy of breastfeeding
Timepoint
The beginning of the study, the third, 15th and 60th day after delivery.
Method of measurement
Breastfeeding adequacy questionnaire

Secondary outcomes

1

Description
Infant weight
Timepoint
3rd day, 10th day and 30th day after birth
Method of measurement
scales

2

Description
Around the infant's head
Timepoint
3rd day, 10th day and 30th day after birth
Method of measurement
tape measure

3

Description
Around the infant's chest
Timepoint
3rd day, 10th day and 30th day after birth
Method of measurement
meter reading

Intervention groups

1

Description
Intervention group:In the first session, the researcher holds a training session and teaches them about the definition, importance and types of Aramaic body through lectures and film screenings. The researcher teaches mental relaxation technique technique practically for women. Then the second session is held on another day and the women are asked to implement the training techniques for the researcher. The maximum duration of each training session is 60 minutes. Until the day of delivery, women perform mental relaxation techniques at home twice a day (in the morning and evening) and each time for 20 minutes. The mental relaxation technique continues until 60 days after delivery, and during this period, mothers follow up They can feed their baby exclusively with their own milk for 60 days after giving birth. After completing the intervention, women refer to the research environment on days 3, 10 and 30 after giving birth. In these sessions, the infant's weight, head circumference and chest circumference are measured.
Category
Treatment - Other

2

Description
Control group: The participants in the control group will only receive the usual breastfeeding training from the instructors of childbirth preparation classes that are taught to both groups during the seventh and eighth sessions, and no additional training will be provided by the researcher.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Noorani Talash Hospital
Full name of responsible person
Dr. Mohsen Sharqi
Street address
No.11, Next to the workers Stadium,Talesh-Rasht Road,Talesh Town
City
Talesh
Province
Guilan
Postal code
1466863986
Phone
+98 13 4422 1102
Fax
+98 13 4425 1109
Email
nooranih@gums.ac.ir
Web page address
https://noorani.gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences Building, Parvaneh Ave., Yemen Ave., Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
zarghi@sbmu.ac.ir
Web page address
https://sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Sepideh Hajian
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti School of Midwifery Nursing, Valiasr Ave., Niayesh Intersection, Opposite Shahid Rajaei Heart Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8856 5366
Fax
+98 21 8856 5368
Email
s.hajian@sbmu.ac.ir
Web page address
https://sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Sepideh Hajian
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti School of Midwifery Nursing, Valiasr Ave., Niayesh Intersection, Opposite Shahid Rajaei Heart Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8856 5366
Fax
+98 21 8856 5368
Email
s.hajian@sbmu.ac.ir
Web page address
https://sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Sepideh Hajian
Position
Counultant
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti School of Midwifery Nursing, Valiasr Ave., Niayesh Intersection, Opposite Shahid Rajaei Heart Hospital
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8856 5366
Fax
+98 21 8856 5368
Email
s.hajian@sbmu.ac.ir
Web page address
https://sbmu.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
Undecided - It is not yet known if there will be 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
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