Viewing Study NCT06505733



Ignite Creation Date: 2024-10-26 @ 3:35 PM
Last Modification Date: 2024-10-26 @ 3:35 PM
Study NCT ID: NCT06505733
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-07-11

Brief Title: Postnatal Companion Support The Effect of Education on Maternal Depression and Fatigue
Sponsor: None
Organization: None

Study Overview

Official Title: Postnatal Companion Support The Effect of Education on Maternal Depression and Fatigue A Randomised Controlled Trial
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In this study it is aimed to investigate the effect of the trainings included in the content of the practical guide for postpartum supporter training companions which will be given to the companions of women in the postpartum period on depression and fatigue on mothers The research will be conducted in methodological and single blind randomised control design The study will be conducted at Necmettin Erbakan University Faculty of Medicine Hospital A total of 70 puerperants will be included in the study as intervention n 35 and control n 35 groups Introductory Information Form Postpartum depression rating scale as data collection tools in the study Motherhood Monitoring Scale by Parents MMSP Edinburgh Postnatal Depression Scale EDDS Multidimensional Fatigue Rating Scale will be used The research data will be collected three times as pre-test data fourth day and tenth day Number percentage mean and standard deviation will be used in the evaluation of descriptive data Chi-square test will be used for the similarity of the descriptive characteristics of the experimental and control groups Kolmogrow-Smirnov and Shapiro-Wilk will be used in the normality analysis of dependent variables t test in independent groups student t test will be used to compare the post-test scores of the experimental and control groups and ANOVA in dependent groups will be used to compare the pre-test-post-test mean scores of the experimental group and eta square will be used to calculate effect sizes The results obtained will be tested at p005 significance level and bidirectionally When the literature is examined there is not enough data on the depression and fatigue of the companion caring for the woman in the postpartum period This study aims to fill the gaps in the literature and to reduce depression and fatigue in mothers
Detailed Description: One of the most important turning points in a womans 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 084 with a specificity of 088 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 mothers 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 womans 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None