Objectives: The Postpartum period is a critical time for a woman, as well as for her newborn and family. Women in this period need help and support. This study will be undertaken to determine whether the education based on continuous care model affect on quality of life and sleep? Design: This interventional study, conducted on 86 mothers who admitted in Tehran Baharloo hospital. Women are divided in two groups of 43 as the intervention group and the control group. To avoid data transfer, sampling will be done for the control or intervention group within every other day. Participants: 86 Iranian mothers with vaginal delivery; without complications after delivery; willingness to breast feeding. Exclusion criteria including the mothers unwillingness to continue participation in the trial; maternal and infant hospitalization during the study; neonatal or infant death during the study; lack of breast feeding. Intervention: In the experimental group, intervention is applying based on continuous care model. The continuous care was performed in four stages: orientation; sensitization; control; evaluation. The intervention group will be received 30-60 minutes face to face education and one educational researcher made booklet at the time of discharge and will receive telephone follow up or home visit for the next 3 months. The control group will receive usual care after giving birth. Main outcome variables: Quality of life and Quality of Sleep. The day before discharge, will be completed Edinburgh Postnatal Depression questionnaire, Pittsburgh Sleep Quality Index (PSQI) and Specific Postnatal quality of Life questionnaire will be completed. After the end of intervention, Pittsburgh Sleep Quality Index and Specific Postnatal quality of Life questionnaire will be re-completed in both intervention group and the control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403152324N14
Registration date:2014-07-20, 1393/04/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-20, 1393/04/29
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1813
Email address
keshavarz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2014-04-13, 1393/01/24
Expected recruitment end date
2014-08-21, 1393/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Training Based on Continuous Care Model on Quality of Life and Quality of Sleep in the Postpartum Period
Public title
Quality of Life in Postpartum
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Live, healthy and term infant; No history of Physical and mental illness in the mother; Lack of postpartum complication such as postpartum hemorrhage, preeclampsia, infection; No incidence of adverse events, including death and … in the last 3 months; Willingness to breast feeding; Demands of pregnancy; Ability to read and write Exclusion criteria: Mother or infant hospitalization during the study; Baby and infant deaths during the study; Psychological problems after childbirth; The incidence of adverse events during the study, including the death of relatives; Lack of exclusive breastfeeding
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
86
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
1
Registry name
No
Secondary trial Id
No
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commitment of Tehran University of Medical Sciences
Street address
Sixth floor, Central office, Ghods St, Keshavarz Blvd- Tehran, Iran
City
Tehran
Postal code
Approval date
2014-02-17, 1392/11/28
Ethics committee reference number
2716/ 130/ د/ 92
Health conditions studied
1
Description of health condition studied
Quality of Life after childbirth
ICD-10 code
Z39.2
ICD-10 code description
Routine postpartum follow up
2
Description of health condition studied
Quality of Sleep after Childbirth
ICD-10 code
O94,O99
ICD-10 code description
Other Obstetric Conditions, Not elsewhere classified
Primary outcomes
1
Description
Quality of Life
Timepoint
Before the intervention, and 3 months after intervention
Method of measurement
Specific Postnatal Quality of Life
2
Description
Quality of sleep
Timepoint
Before the intervention, and 3 months after intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
1
Description
No
Timepoint
No
Method of measurement
No
Intervention groups
1
Description
In addition to routine care, continuous care model program has been running for 3 months . Before hospital discharge, demographic questionnaire, postpartum depression, postpartum QOL questionnaire and the Pittsburgh Sleep Quality Index has been aggregated and then a meeting for 30 to 60 minutes training manual for mothers has been explained and it is given to mothers, then follow-up (weekly phone calls and in person at home if necessary) will be conducted in the first 12 weeks postpartum. The average of phone calls will be 20 minutes and based on client needs it may be changed. There is possibility for maternal subjects to have 24 hour calls with the researcher. 12 weeks later the same questionnaire to be completed.
Category
Lifestyle
2
Description
Control group:The control group will receive usual care after giving birth
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharloo hospital
Full name of responsible person
Maryam keshavarz
Street address
Behdari St, Rah Ahan Sq, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotohi
Street address
Sixth floor, Central office, Ghods St, Keshavarz Blvd,Tehran, Iran
City
Tehran
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, Tehran 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
Tehran University of Medical Science
Full name of responsible person
Masome Asghari
Position
MA
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat ST, Tohid Sq, Tehran
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
masome.asghari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Assistant Professor in Midwifery education
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Rashid Yasami Av, Upper Vanak Sq, Vali-e-Asr St,Tehran
City
Tehran
Postal code
Phone
+98 21 6105 4219
Fax
Email
Keshavarz.m@iums.ac.ir ; m_keshir@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing Midwifery, Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Assistant Professor in Midwifery education
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Rashid Yasami Av, Upper Vanak Sq, Vali-e-Asr St,Tehran
City
Tehran
Postal code
Phone
+98 21 6105 4219
Fax
Email
Keshavarz.m@iums.ac.ir ; m_keshir@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)