This research will be random clinical trial in two groups on 60 mothers having premature neonate (gestational age between 32–36 week) bed ridden in the NICU Mashhad University of Medical Sciences Research and Training centers. Sampling will be done based inclusion criteria. Sampling will be based on inclusion criteria using two-month time block method. The control group receives the ward's regular treatment. The experimental group includes mothers with premature infants admitted in NICU that are selected during the first 24-72 hours after delivery and undergo relaxation training. Progressive muscular relaxation training for mothers is done by the researcher using Jacobson's method in the form of sixteen fold contractions and stretching of body, practically and individually, for thirty to forty five minutes. Mothers are required to do the method at least once a day. Self-efficacy variable of breastfeeding and quality of sleep is measured with breastfeeding self-efficacy questionnaire (Denis 2003) and Petersburg's Sleep Quality Index (PSQI). The questionnaire is initially evaluated during the first 24-72 hours of delivery and then four weeks after delivery and eventually during the eighth week after delivery. Mother inclusion criteria: The mother should be willing to take part in the research, Should be over 18 and under 35 years old, drug abuse is not. Mother exclusion criteria: When the mother hasn't done the relaxation exercise more than three times in a row.
General information
Acronym
Relaxation training
IRCT registration information
IRCT registration number:IRCT2013082914516N1
Registration date:2013-12-28, 1392/10/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-28, 1392/10/07
Registrant information
Name
Sayedeh Maryam Hoseini
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 2257 2959
Email address
hoseinig901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Mashhad University of Medical Sciences
Expected recruitment start date
2013-10-24, 1392/08/02
Expected recruitment end date
2014-01-30, 1392/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of relaxation training on breastfeeding self-efficacy and quality of sleep in mothers with premature infants
Public title
Effects of relaxation training on breastfeeding self-efficacy and quality of sleep in mothers with premature infants
Purpose
Supportive
Inclusion/Exclusion criteria
Mother inclusion criteria: the mother should be willing to take part in the research; should be over 18 and under 35 years old; should have finished at least fifth grade of elementary school; shouldn't have skeletal and muscular problems; should have poor quality sleep (Petersburg's Sleep Quality Index score being 5 or above); should be physically fit; should not have temperamental and emotional disorders that hinder effective communication; should have access to audiovisual equipments at home; there may be a phone call; drug abuse is not. Neonate inclusion criteria: age between 32 - 36 weeks; no IUGR; the infant shouldn't be congenitally abnormal; enteral feeding for the infant should have been started in the form of po or pg. Neonate exclusion criteria: the infant should be put on a ventilator; the infant's digestive system should undergo surgery; after feeding has been started, the infant should undergo NPO for more than two days; neonate dies.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery Mashhad, Four ways PhD
City
Mashhad
Postal code
Approval date
2013-10-23, 1392/08/01
Ethics committee reference number
research/920827/1/296
Health conditions studied
1
Description of health condition studied
Breastfeeding self-efficacy and quality of sleep
ICD-10 code
O94-O99
ICD-10 code description
Other obstetric conditions, not elsewhere classified
Primary outcomes
1
Description
Breast feeding self-efficacy
Timepoint
Two months after the start of the intervention
Method of measurement
Dennis questionnaire
Secondary outcomes
1
Description
Quality of sleep
Timepoint
Two months after the start of the intervention
Method of measurement
Pittsburgh sleep quality index (PSQI)
Intervention groups
1
Description
The experimental group includes mothers with premature infants admitted in NICU that are selected during the first 24-72 hours after delivery and undergo relaxation training. Progressive muscular relaxation training for mothers is done by the researcher using Jacobson's method in the form of sixteen fold contractions and stretching of body, practically and individually, for thirty to forty five minutes. Mothers are required to do the method at least once a day.
Category
Other
2
Description
The control group receives the ward's regular treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU, Educational and Research Center Mashhad University of Medical Sciences
Full name of responsible person
Soheyla Karnadi
Street address
Mashhad School of Nursing and Midwifery
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Building Qureshi
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sayedeh Maryam Hoseini
Position
MSc in Nursing,neonatal intensive care
Other areas of specialty/work
Street address
School of Nursing and Midwifery Mashhad, Four way Phd
City
Mashhad
Postal code
Phone
+98 38 1222 3435
Fax
Email
hoseinig901@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Mashhad
Full name of responsible person
Soheyla Karbandi
Position
MSc Nursing,Faculty member of School of Nursing and Midwifery, Mashhad
Other areas of specialty/work
Street address
School of Nursing and Midwifery Mashhad, Four way Phd
City
Mashhad
Postal code
Phone
+98 51 1768 5137
Fax
Email
karbandis@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sayedeh Maryam Hoseini
Position
MSc in Nursing,neonatal intensive care
Other areas of specialty/work
Street address
School of Nursing and Midwifery Mashhad, Four way Phd
City
Mashhad
Postal code
Phone
+98 38 1222 3435
Fax
Email
hoseinig901@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)