- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06505733
Postnatal Companion Support The Effect of Education on Maternal Depression and Fatigue
Postnatal Companion Support The Effect of Education on Maternal Depression and Fatigue: A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
One of the most important turning points in a woman's life is the pregnancy and birth process. In some cases, these milestones can turn into a crisis and lead to mental problems. In addition, for parents, preparing for and caring for a new baby is inherently a period of change and transition. With the addition of the responsibility of caring for the baby, more negative health problems may occur in the postpartum period. It is a risky period in terms of fatigue, emotional disorders, and postpartum depression during the transition to motherhood in the postpartum period. In the first three postnatal days, more than 50% of mothers experience maternal sadness, which is the mildest psychological disorder with symptoms of crying, sadness and unstable emotions. When this situation cannot be managed, postnatal depression occurs. According to previous research, 15% of mothers experience postnatal depression. The main symptoms of postnatal depression include lack of interest, low self-confidence, fatigue, sadness, sleep disturbance, loss of appetite, hostile attitude towards babies, self-blame and feelings of humiliation, and symptoms last for at least two weeks. Postnatal fatigue (PFF) is generally known to cause both a decrease in energy that prevents mothers from engaging in physical and mental activities after birth and impaired concentration and distraction that cannot be easily eliminated by rest or sleep. Edinburgh Postnatal Depression Scale is the gold standard for screening. The Turkish version has been used in Turkey since 1996 and the cut-off score is accepted as 13. In Turkey, the sensitivity of the scale is estimated to be 0.84 with a specificity of 0.88, indicating that 16% of women are overlooked for postnatal depression. It should be underlined that the scale is not routinely used in postnatal care and follow-up. In addition, it is difficult for women to diagnose themselves in terms of postnatal depression. Moreover, many mothers believe that they should not complain about the mental difficulties brought by the postnatal period. Therefore, self-assessment as well as the assessment of others is important.
In developed countries, almost all women and their babies receive labour and postnatal care. However, the quality and frequency of this care vary significantly. In developing countries, the need for care and support after birth remains unmet. Despite all its importance, this period is often the most neglected period. In the study conducted to evaluate the postnatal care services provided in family medicine units in terms of quantity and quality in our country, it is stated that although it is seen that postnatal care is provided at the level of developed countries in terms of quantity, the services provided in terms of content are insufficient, and the services provided should be evaluated not only in terms of quantity but also in terms of quality. PPF should provide physical relaxation by deliberately preventing and alleviating fatigue in the postpartum period with effective approaches. Postnatal care is defined as the most neglected aspect of maternity services and it is generally stated that less resources are allocated to it than antenatal care or delivery. Many developing countries with limited resources have difficulty in developing and implementing policies to prevent the treatment gap from increasing. Prevention or early detection and intervention programmes have been developed to reduce the burden of these two disorders. Effective community-based programmes have been shown to reduce depression. However, due to the lack of home visits in postnatal care services and inadequate quality, companion support is important in the postnatal period. Especially considering the quality of postnatal care in our country and the lack of home visits, the importance of companion support in this period comes to the fore. In a study examining the effect of companion support on acute stress reactions and postnatal depressive symptoms in the first three weeks after birth, it was reported that companion support reduced acute stress reactions and postnatal depressive symptoms. In a study, it is stated that companion support has a positive effect on the mother's mood and self-efficacy. In another study, it was stated that early and appropriate interventions to reduce PPF may increase the mitigation of negative effects on physical activity and therefore improve postnatal maternal health. In this period, the importance of the evaluation of the woman's own condition as well as the evaluation of health professionals and companions is emphasised. It is stated that observation of postnatal women by a close third person, especially by spouses and parents, will be beneficial.
Postnatal depression and fatigue are common problems in our country. However, postnatal care services are inadequate and unqualified. For this reason, studies should be carried out on alternative supports in postnatal care. In this context, "Postpartum Depression Parent Rating Scale for Postpartum Depression" was developed to increase the quality of early postnatal diagnosis and care: The Turkish validity and reliability study of the "Postpartum Depression Parent Rating Scale: Mother Monitoring Scale by Parents" and proving the effect of companion training on postpartum depression and fatigue constitute the original value of the project and our main motivation. The project has a unique value for a sustainable future in terms of its effects on the social level in terms of positive postnatal period and qualified support for puerperas and babies in general. In the project, ensuring that puerperas receive evidence and science-based postnatal support and care in line with our culture and traditions is also of unique value. It will also provide data for the comparison of innovative care models with traditional methods. Thus, it will help to improve, organise or develop capacity for future initiatives.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: HURİYE M.Sc. ALTINKAYNAK, degree
- Phone Number: 05511485563
- Email: asaltinkaynak@hotmail.com
Study Contact Backup
- Name: Hediye Ass.Prof. Karakoç, assistant professor
- Phone Number: 05412291726
- Email: hediye.bekmezci@karatay.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Knowing how to read and write Turkish,
- Volunteer to participate in the research,
- She gave birth by cesarean section,
- Primiparous,
- Pregnant women who are open to communication (able to understand and answer questions) will be included in the sample.
Exclusion Criteria:
- Those who do not have the skills of reading, listening, writing, speaking and understanding Turkish,
- Those who have a hearing or visual impairment,
- Having postpartum complications,
- giving birth to stillbirth,
- People who wanted to withdraw from the study were not included.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: attendants in the postnatal period
In the guide, the needs of the postpartum mother and baby, postpartum depression (definition, symptoms, risk factors, complications, care), the role and responsibilities of the companion in supporting the postpartum mother are included.
|
Intervention Group: Training and counselling will be provided to the puerperant and companions before discharge in a quiet and stimulus-free environment using the "Companion Training Guide".
Research data will be collected three times: pre-test data, after the training and on the tenth day.
Other Names:
|
|
No Intervention: non-intervention group
the group will not be trained
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in the depression level of the companion on the 10th day of the postnatal period compared to the baseline value
Time Frame: 0-10 day
|
The EPDS is a self-report scale consisting of 10 items in a 4-point Likert format.
The responses consisting of four options are scored between 0-3, the lowest score that can be obtained from the scale is 0 and the highest score is 30.
As the score increases, the level of depression increases.
" Parent Rating Scale for Postpartum Depression: Maternity Monitoring Scale by Parents" , approval was received from the author after the translation of the scale questions.
|
0-10 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in the fatigue level of the attendant on the 10th day of the postnatal period compared to the baseline value
Time Frame: 0-10 day
|
ÇBYDS is a four-point Likert type scale consisting of 16 questions.
As the score increases, his fatigue increases.
|
0-10 day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hediye Ass. Prof. Karakoç, assistant professor, KTO Karatay Univeristy
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KaratayU-EBE-HA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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