Objective: Determining and comparing the impact of face to face training and E- learning on the fatigue and sleep quality of the mother and baby in the postpartum period
Design: sampling method is convenience and the samples were randomly placed in groups.
Method: Providing training in the intervention group about sleeping of mother and her baby, health, nutrition, rest, relaxation techniques. Filling out the questionnaire without providing any training in the control group.
The population: mothers and infants from the tenth to the sixtieth day after birth.
Inclusion criteria: not having postpartum depression and underlying disease in the mother.
Exclusion criteria: postpartum depression.
The sample size: 120 subjects.
Intervention: Training in the field of sleep disorders in the mother and her infant during postpartum by face-to-face and E- learning methods like providing CD and sending Bluetooth on the phone.
The intervention time: 10 days after delivery.
The outcome: reduced fatigue and sleep disorders in the mother and infant in the postpartum period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062722939N1
Registration date:2015-08-31, 1394/06/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-31, 1394/06/09
Registrant information
Name
Zahra Gholami
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7514
Email address
zahra.gholami@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan university of medical science
Expected recruitment start date
2015-07-11, 1394/04/20
Expected recruitment end date
2015-09-21, 1394/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of face to face training and E-learning on the fatigue and maternal and baby’s quality of sleep in the postpartum period
Public title
The impact of education on the fatigue and sleep disorders in the mother and infant in the postpartum period
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: People giving birth to live, singleton healthy, people who are breastfeeding (exclusive breastfeeding or with milk), No risk of bleeding during and after delivery (with the question of the mother), After delivery of the highest hospitalization was 3 days, having an underlying medical condition (asthma, kidney disease, congestive heart failure, gastroesophageal reflux disease, rheumatic disorders, joint pain and other musculoskeletal, diabetes) who are sleep disorders, Lack of depression during the study period (with the use of the Edinburgh Postnatal Depression Scale short-be determined (according to the Edinburgh questionnaire, people who score less than 13 get-out, depressed and those with scores equal to or greater than 13 acquire, they will be considered depressed), Married Women and Iranian nationality, no drug addiction and no Hypnotic drugs addiction (for example benzodiazepines), no repeated spontaneous abortions, no neonatal death, Non-working mother";" Exclusion criteria: Unwillingness to continue cooperation during the study, not completing the questionnaire completely and correctly, people who suffer from postpartum depression during the study (diagnosed with the information given to mothers at the beginning of the study), providing any disease or disorder that it effects on the sleep of the mother and infant during the study such as long-term cold (more than three days), infectious diseases that cause fever, prolonged fever, hospitalization of the mother and infant, factors such as postpartum bleeding after the sampling.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For randomization, among all cases in health centers, 10 cases of postpartum mothers on the basis of inclusion criteria will be selected randomly. Random selection of cases will be on the basis of weekdays. Meaning that Saturday and Tuesday will be assigned to face-to-face training group, Sunday and Wednesday will be assigned to E-learning group, Monday and Thursday will be dedicated to the control group. Then every day, with convenient sampling method, qualified individuals are selected for inclusion.
Secondary Ids
1
Registry name
---
Secondary trial Id
---
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comitte of Isfahan university of Medical Sciences
Street address
Hezar jarib street, Isfahan university of medical science, Isfahan.
City
Isfahan
Postal code
8174673461
Approval date
2015-07-07, 1394/04/16
Ethics committee reference number
IR.MUI.REC.1394.3.301
Health conditions studied
1
Description of health condition studied
Fatigue and sleep disorder
ICD-10 code
F53
ICD-10 code description
Other mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
The mother fatigue
Timepoint
Before and one and two months after the intervention
Method of measurement
Intensity of fatigue Questionnaire
2
Description
The sleep quality of the mother
Timepoint
Before and one and two months after the intervention
Method of measurement
The Pittsburgh Sleep Quality questionnaire
3
Description
The sleep quality of infant
Timepoint
Before and one and two months after the intervention
Method of measurement
The record form of mean duration of infant’s sleep
Secondary outcomes
1
Description
-----
Timepoint
------
Method of measurement
-----
Intervention groups
1
Description
Intervention group 1: Face to face training on the tenth day after birth for 45-30 minutes and then send the hygienic SMS until the sixtieth day after birth
Category
Behavior
2
Description
Intervention group 2: Giving an educational CD on the tenth day after birth and then sending the hygienic SMSs until the sixtieth day after birth.
Category
Behavior
3
Description
Control group: No intervention
Just fill out the questionnaire.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Hamzeh Health Center
Full name of responsible person
zahra gholami
Street address
Amir Hamzeh Health Center, Ghaemie, Isfahan.
City
Isfahan
2
Recruitment center
Name of recruitment center
Nawab Safavi Health Centre
Full name of responsible person
zahra gholami
Street address
Ahmadabad square, Isfahan
City
Isfahan
3
Recruitment center
Name of recruitment center
Ibn Sina Health Center
Full name of responsible person
zahra gholami
Street address
Ibn Sina street, Shohada square, Isfahan
City
Isfahan
4
Recruitment center
Name of recruitment center
25-dastgerd Health center
Full name of responsible person
zahra gholami
Street address
Ghaemie, 25dastgerd Health Center, Isfahan.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan university of medical science
Full name of responsible person
Mehdi Nemat bakhsh
Street address
Vice chancellor for research, Isfahan university of medical science, Faculty of Nursing and Midwifery
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan university of medical science