The effect of planned home visits made to the mothers with premature babies after hospital-discharge upon their postpartum depression, adaptation to motherhood role and newborns health
| ISRCTN | ISRCTN24709858 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24709858 |
| Protocol serial number | N/A |
| Sponsor | Hitit University (Turkey) |
| Funder | Investigator initiated and funded (Turkey) |
- Submission date
- 01/07/2013
- Registration date
- 11/07/2013
- Last edited
- 12/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Birth before completing 37 weeks of pregnancy is called preterm labor and these babies are called as premature babies. Premature babies may have risk of many health problems and complications because their organs and systems are less developed than those of full term babies. Today, one out of ten births results in preterm labor and majority of these babies do not survive longer the initial days of live their life. Therefore, care of the premature babies that is performed during their early days at the hospital and at home after hospital-discharge, is very important. Besides, it is reported that mothers with premature babies experience such psychological problems and worry more compared to those mothers who give birth to full term babies. Therefore, those mothers with premature babies should be supported on baby care through home visits after hospital-discharge in order to prevent possible health problems to the baby, to maintain good mother-baby relationship during this period and to decrease psychological problems. Research reports that home visits paid during early days after hospital-discharge offer many advantages in terms of mother and baby health. But, research on home care after child birth is very scarce. This study was conducted in order to find out how well planned home visits paid to the mothers with premature babies after hospital-discharge works.
Who can participate?
Mothers who gave birth before the 37th week of the pregnancy at the Corum State Hospital between the January 2011 and the June 2011.
What does the study involve?
Participants were randomly allocated to either intervention group or to control group. Women belonging to the intervention group received training during their stay in the hospital and when they got discharged, they were given consultation based on a handbook. The researcher visited them at home 4 times during their early days after discharge where they were given training and consultation about baby care. The control group did not receive any training.
What are the possible benefits and risks of participating?
Benefits include training about the newborn health, mothers and the babies health problem could be identified early, participants are directed to a health institution for the treating these problems. There is no risk of participating in the study as the methods are not invasive.
Where is the study run from?
The study was performed at the intensive care unit of the newborn, Corum State Hospital, Turkey.
When is the study starting and how long is it expected to run for?
The study started in January 2011 and ended in May 2011.
Who is funding the study?
This study is funded by the investigator.
Who is the main contact?
Dr Nuriye Buyukkayaci Duman
nurfatihh@hotmail.com
Contact information
Scientific
Hitit University School of Health
Corum
19030
Türkiye
| nurfatihh@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Semi-experimental case-control study |
| Secondary study design | Case-control study |
| Study type | Participant information sheet |
| Scientific title | The effect of planned home visits made to the mothers with premature babies after hospital-discharge upon their postpartum depression, adaptation to motherhood role and newborns health: a semi-experimental case-control study |
| Study objectives | Hypothesis of the research H 1.Home visits paid to mothers with premature babies after hospital-discharge may have a decreasing effect upon mean postpartum depression scores. H 2.Home visits paid to mothers with premature babies after hospital-discharge may have a positive effect upon adaptation to motherhood role. H 3.Home visits paid to mothers with premature babies after hospital-discharge may have a decreasing effect upon health problems of the newborn. |
| Ethics approval(s) | Ethical Committee of Medical Faculty of Erciyes University with approval number of 2011/233 |
| Health condition(s) or problem(s) studied | Postpartum depression, adaptation to motherhood role and newborns health (nutritional problems, respiratory distress syndrome, anemia) |
| Intervention | Women in the intervention group and control group were at the Intensive Care Unit of Newborn of Corum State Hospital. After all patients were informed of the purpose the study and their oral consents were obtained; both groups were given Descriptive Data Collection Form about mothers and their babies characteristics. The researcher provided training for the women in the intervention group during the period when they were treated at the hospital and while they were being discharged from the hospital, they were given consultation about baby care according to the handbook The Care of the Newborn Baby. The researcher did not provide the women in the control group with nursing intervention of any kind. After hospital-discharge (on the 7th day, 14th day, 28th day and 42nd day after birth), women in the intervention group were seen at their homes by the researcher. They were telephoned before the home visits and appointments were made and visit-day and hours were fixed. During each home visit, the researcher provided women in the intervention group with training about baby care according to the handbook and gave them consultation related to mothers needs. During the final home visit on the 42nd day after birth, women were given the Form to determine the Newborns Problems, Form of Adaptation to Motherhood Role (in order to determine mothers adaptation to motherhood) and Beck Depression Inventory (BDI) (in order to determine mothers postpartum depression). |
| Intervention type | Other |
| Primary outcome measure(s) |
1. The Form to determine the Newborns Problems: |
| Key secondary outcome measure(s) |
Descriptive Data Collection Form about Mothers and their babies Characteristics |
| Completion date | 01/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 60 |
| Key inclusion criteria | Women who lived in the city center of Corum, gave birth before the 37th gestational week and accepted to participate in the research voluntarily were included in the research. |
| Key exclusion criteria | Those women and/or their babies who developed complications (mothers: postpartum hemorrhage, infection, etc.; babies: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, neonatal asphyxia, etc.) and the women who had chronic diseases (heart diseases, hypertension, diabetes, renal diseases) were excluded from the study due to the idea that they may be affecting the results of the study. |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 01/05/2011 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
19030
Türkiye
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
