Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
80 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-05-01
Study Completion Date
2025-03-30
Brief Summary
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Postpartum depression is a global mental health problem affecting 13 million women worldwide each year. It is defined as minor or major depression that occurs up to one year after birth and is estimated to affect 5 to 25% of mothers who have just given birth . Postpartum depression can cause negative consequences not only on the mother but also on the newborn and the whole family. The main goal in the postpartum period is to maintain the well-being of mother and baby. However, if a depression is experienced during this period, the main goal is to take action to reduce its severity. Exercise is a potentially promising method to prevent postpartum depression. However, more studies are needed to determine the effects of exercise on women who live in rural Türkiye and have limited access to health services. Therefore, this study aims to determine the effect of a mobile-based exercise program applied to women giving birth in rural areas on postpartum depression, mother-baby attachment and baby crying behavior.
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Detailed Description
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Postpartum depression is a global mental health problem affecting 13 million women worldwide each year . It is defined as minor or major depression that occurs up to one year after birth and is estimated to affect 5 to 25% of mothers who have just given birth . Postpartum depression, often associated with periodic depressive episodes, is characterized by emotional lability, guilt, dysphoria, disorientation, and suicidal thoughts and can persist for a long time. Postpartum depression is recognized as an official diagnosis by the World Health Organization's International Classification of Disorders, 10th revision (ICD-10) and the Diagnostic and Statistical Manual of Mental Disorders. While ICD-10 reports that the most critical period for diagnosing postpartum depression is within six weeks after birth, the American Psychiatric Association reported that episodes of postpartum depression can begin within four weeks after birth. Postpartum depression can also turn into permanent and long-term depression, which can increase the likelihood of recurrent episodes of depression in subsequent pregnancies. This is supported by evidence that women with a history of depressive illness are more likely to develop postpartum depression. Postpartum depression can cause negative consequences not only on the mother but also on the newborn and the whole family. Postpartum depression, in particular, has significant effects on mother-infant attachment; It also has negative effects on the mother learning how to care for her baby and transitioning into the parenting role. Postpartum depression can lead to early cessation of breastfeeding or breastfeeding problems; It may also cause the use of preventive health services and vaccination rates in children to be low. Impairments in social participation and emotional regulation, increased negative emotionality, and high cortisol reactivity may be observed in babies of mothers with depression.
During the postpartum period, not only mothers but also their babies may show some behavioral reactions. One of these is crying. There are many possible causes of crying problems in babies, but none of them are certain. It has generally focused on conditions that cause excessive crying in the baby, such as immaturity of the intestinal flora, cow's milk allergy and intestinal microbiota composition. Many studies have raised the question of whether the cause may lie in maternal factors. Crying problems in babies have been associated with low maternal age and education level. Some researchers agree that crying problems arise from the complex mother-infant dyad, and it is well known that maternal postpartum depression and infant crying influence each other . Systematic reviews on this topic have generally found associations between the mother's mental problems (stress, anxiety, or depression) during pregnancy and the baby's regulatory problems, including crying.
The main goal in the postpartum period is to maintain the well-being of mother and baby. However, if a depression is experienced during this period, the main goal is to take action to reduce its severity. Postpartum depression is a specific psychological disorder for which preventive interventions can provide dramatic benefits. In their meta-analysis study by It has been stated that practices such as cognitive behavioral therapies, social support groups, psycho-educational training, physical exercises, yoga, and lack of nutritional supplements are interventions that can be used to reduce the severity of postpartum depression..
Exercise is a potentially promising method to prevent postpartum depression. Since the aim of exercise is to improve or maintain one or more aspects of physical fitness, it is defined as a planned, systematic, repeated and purposeful action.Previous studies have provided compelling evidence regarding exercise in the postpartum period. It has been reported that exercises performed in the postpartum period provide psychosocial well-being, less anxiety and depression, better cardiovascular adaptation, body fat/weight control, less bone loss due to breastfeeding and less stress incontinence, and strengthen the bonding between mother and baby.
Studies generally point to the importance of regular exercise in the postpartum period. However, the number of women exercising in the postpartum period is limited, and lack of access to affordable and appropriate activities is a perceived barrier to exercise. The increasing number of mobile-based applications in recent years offers affordable and accessible exercise applications. These apps use a variety of features, from tracking exercise activity to providing motivational messages. However, what is known about whether exercise practices improve health outcomes and, if so, the mechanisms of these effects is limited. Therefore, there is a need for more studies in this important area to determine the effects of exercise using new technologies as an alternative to face-to-face exercise programs, especially for women living in rural Türkiye and with limited access to health services.
Women who give birth in Türkiye are followed up in the hospital for 24 hours and then followed up three times during the postpartum period at home or in Family Health Centers (FHC) within the scope of health services. Health professionals have a unique duty to follow up women in the postpartum period, identify women at risk for depression, and encourage mothers to use preventive practices such as exercise. It is very important for midwives and nurses to explain mobile-based exercise programs to prevent the development of depression, especially to women living in rural areas, in the postpartum period, to persuade women to participate in these programs, and to perform exercises regularly under the supervision of doctors and physiotherapists in terms of protecting the health of women and their families. Therefore, the aim of this study is to determine the effect of a mobile-based exercise program applied to women giving birth in rural areas on reducing the severity of postpartum depression, mother-baby bonding, and baby crying behavior.
During the postpartum period, not only mothers but also their babies may show some behavioral reactions. One of these is crying. There are many possible causes of crying problems in babies, but none of them are certain. It has generally focused on conditions that cause excessive crying in the baby, such as immaturity of the intestinal flora, cow's milk allergy and intestinal microbiota composition. Many studies have raised the question of whether the cause may lie in maternal factors. Crying problems in babies have been associated with low maternal age and education level. Some researchers agree that crying problems arise from the complex mother-infant dyad, and it is well known that maternal postpartum depression and infant crying influence each other . Systematic reviews on this topic have generally found associations between the mother's mental problems (stress, anxiety, or depression) during pregnancy and the baby's regulatory problems, including crying.
The main goal in the postpartum period is to maintain the well-being of mother and baby. However, if a depression is experienced during this period, the main goal is to take action to reduce its severity. Postpartum depression is a specific psychological disorder for which preventive interventions can provide dramatic benefits. In their meta-analysis study by It has been stated that practices such as cognitive behavioral therapies, social support groups, psycho-educational training, physical exercises, yoga, and lack of nutritional supplements are interventions that can be used to reduce the severity of postpartum depression..
Exercise is a potentially promising method to prevent postpartum depression. Since the aim of exercise is to improve or maintain one or more aspects of physical fitness, it is defined as a planned, systematic, repeated and purposeful action.Previous studies have provided compelling evidence regarding exercise in the postpartum period. It has been reported that exercises performed in the postpartum period provide psychosocial well-being, less anxiety and depression, better cardiovascular adaptation, body fat/weight control, less bone loss due to breastfeeding and less stress incontinence, and strengthen the bonding between mother and baby.
Studies generally point to the importance of regular exercise in the postpartum period. However, the number of women exercising in the postpartum period is limited, and lack of access to affordable and appropriate activities is a perceived barrier to exercise. The increasing number of mobile-based applications in recent years offers affordable and accessible exercise applications. These apps use a variety of features, from tracking exercise activity to providing motivational messages. However, what is known about whether exercise practices improve health outcomes and, if so, the mechanisms of these effects is limited. Therefore, there is a need for more studies in this important area to determine the effects of exercise using new technologies as an alternative to face-to-face exercise programs, especially for women living in rural Türkiye and with limited access to health services.
Women who give birth in Türkiye are followed up in the hospital for 24 hours and then followed up three times during the postpartum period at home or in Family Health Centers (FHC) within the scope of health services. Health professionals have a unique duty to follow up women in the postpartum period, identify women at risk for depression, and encourage mothers to use preventive practices such as exercise. It is very important for midwives and nurses to explain mobile-based exercise programs to prevent the development of depression, especially to women living in rural areas, in the postpartum period, to persuade women to participate in these programs, and to perform exercises regularly under the supervision of doctors and physiotherapists in terms of protecting the health of women and their families. Therefore, the aim of this study is to determine the effect of a mobile-based exercise program applied to women giving birth in rural areas on reducing the severity of postpartum depression, mother-baby bonding, and baby crying behavior.
Conditions
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Postpartum Depression
Mother-Infant Interaction
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This research will be conducted in accordance with the pre-test-post-test experimental research model in two groups in order to determine the effect of a mobile-based breathing and relaxation exercise program applied to postpartum women on postpartum depression, mother-infant attachment and baby crying behavior.
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Participants
In the PASS 11 program, when the number of groups is calculated as 2, 5% margin of error and 90% power, it has been determined that at least 54 people should be included in the sample, with each group consisting of at least 27 people. Considering that the women taking part in the study may want to leave the study while it is ongoing and may encounter unexpected medical conditions and may be lost; It was decided to include a total of 80 women, 40 in the intervention group and 40 in the control group. In this single-blind randomized controlled study, the group in which women will be included will be determined and randomized via computer. "Random Allocation Software Program" will be used to randomize women to groups. The randomization process will be generated by the computer into random blocks of permuted length. Women will be assigned to one of the intervention and control groups by the researchers according to the order in the randomization list.
Study Groups
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Exercise Group
In the study, women will perform breathing and relaxation exercises for 8 weeks.
In the first phase of the intervention, women will be given home exercise program training. The training will be held face to face at the Family Health Center. The day and time will be determined according to the women's preference. Afterwards, women will be informed about the exercise program and the exercise program will be shared in writing.
In the second phase of the intervention, a total of four exercise videos will be sent to women every two weeks on Sunday.Exercise videos will be sent to women through social networks such as WhatsApp, Instagram, Facebook and Twitter.
Women's exercise routines will be recorded by researchers by calling the women and monitoring whether they do the exercises through self-report.
Group Type
EXPERIMENTAL
Exercise
Intervention Type
OTHER
During the training, verbal information will be given about the importance of exercise, exercise barriers, and the potential benefits of exercise on the mother and baby in the postpartum period. In the training, the points that the mother should pay attention to before exercise will also be discussed. In the following process, videos containing deep breathing and relaxation exercises will be sent to women. The videos will be recorded by the researchers at Ankara University Physiotherapy application laboratory. Recording videos will be delivered to women through social networks. Women will be allowed to do these exercises for a total of 8 weeks.
Control Group
No intervention will be made to women in the control group. When necessary, women's questions will be answered via phone. At the end of the study, breathing and relaxation exercise training will be given to the control group. Trainings will be held face to face at the Family Health Center. The training program will be planned taking into account the demands of women.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Exercise
During the training, verbal information will be given about the importance of exercise, exercise barriers, and the potential benefits of exercise on the mother and baby in the postpartum period. In the training, the points that the mother should pay attention to before exercise will also be discussed. In the following process, videos containing deep breathing and relaxation exercises will be sent to women. The videos will be recorded by the researchers at Ankara University Physiotherapy application laboratory. Recording videos will be delivered to women through social networks. Women will be allowed to do these exercises for a total of 8 weeks.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
1. Having had a singleton pregnancy,
2. Not having a history of serious illness/chronic disease,
3. Not being restricted from exercising by the physician,
4. Having given birth at term (37-42 weeks of pregnancy),
5. Being within the first 6 months after birth,
6. Having a healthy baby,
7. Knowing how to read and write Turkish and understanding it,
8. Having the skills to use phones, tablets, computers and mobile applications,
9. Not having any problems that would prevent communication,
10. Agreeing to participate in the research. -
2. Not having a history of serious illness/chronic disease,
3. Not being restricted from exercising by the physician,
4. Having given birth at term (37-42 weeks of pregnancy),
5. Being within the first 6 months after birth,
6. Having a healthy baby,
7. Knowing how to read and write Turkish and understanding it,
8. Having the skills to use phones, tablets, computers and mobile applications,
9. Not having any problems that would prevent communication,
10. Agreeing to participate in the research. -
Exclusion Criteria
1. Having a history of multiple pregnancy,
2. Being taking medication for the treatment of illness or chronic disease,
3. Exercising regularly,
4. Having a premature baby (\<37 weeks of gestation),
5. Having a history of illness in the baby,
6. Not having a phone, tablet or computer,
7. Not agreeing to participate in the research. -
2. Being taking medication for the treatment of illness or chronic disease,
3. Exercising regularly,
4. Having a premature baby (\<37 weeks of gestation),
5. Having a history of illness in the baby,
6. Not having a phone, tablet or computer,
7. Not agreeing to participate in the research. -
Minimum Eligible Age
18 Years
Maximum Eligible Age
45 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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republic of turkey ministry of health
UNKNOWN
Sponsor Role
collaborator
Ankara University
OTHER
Sponsor Role
lead
Responsible Party
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Serap Canli
Public Health Nurse Lecturer
Responsibility Role
PRINCIPAL_INVESTIGATOR
Central Contacts
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References
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Related Links
Access external resources that provide additional context or updates about the study.
http://www.ncss.com/wp-content/uploads/2012/09/PASS11UG1.pdf
NCSS. User's Guide I Quick Start, Proportions, and Diagnostic Tests PASS Power Analysis and Sample Size System
http://www.haymana.gov.tr/ilcemiz-nufusu
T.C. Haymana Kaymakamlığı
Other Identifiers
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ANKARA-UNALS-001
Identifier Type: -
Identifier Source: org_study_id
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