- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04043533
The Effect of an Exercise Program in Reducing the Severity of Postpartum Depression in Women
The Effect of an Exercise Program in Reducing the Severity of Postpartum Depression in Women: A Randomized Control Trial
Aim: This study aims to identify the effectiveness of an exercise program in reducing the severity of postnatal depression in women who had a spontaneous vaginal delivery.
Methods: This randomized control trial was conducted with 65 postpartum women residing in a city located in the south-eastern Turkey. In the first postpartum month, following random assignment of subjects, the experimental group (n=40) performed exercises for four weeks, and the control group (n=40) received standard cares. The participating women were administered the Edinburgh Postpartum Depression Scale.
Study Overview
Detailed Description
Postpartum depression is characterized by irritability, guilt, burnout, anxiety, sleep disorders, and somatic symptoms that could have negative effects on the mother, baby, and family.
In a meta-analysis study including 219 prevalence studies from 56 countries that investigated different phases of postpartum using various data collection tools, Hahn-Holbrook et al. (2018) found the depression prevalence at the global level as 17.7% (Hahn-Holbrook, 2018). In Turkey, 23.8% of women in the postpartum period were reported to be suffering from postpartum depression, which underlines the need for health professionals to be concerned about the health of the women in the postpartum period.
Exercises done in the postpartum period are reported to enable psychosocial well-being, less anxiety and depression, better cardiovascular adaptation, body fat/weight control, less bone loss caused by lactation, and less stress incontinence. Studies have generally indicated the importance of regular exercise in the postpartum period. Studies have generally indicated the importance of regular exercise in the postpartum period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Adi̇yaman, Turkey, 02100
- Didem Şimşek Küçükkelepçe
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- must be score of 13 and over in the Edinburgh Postpartum Depression Scale (EPDS),
- must being between 19 and 40 years old,
- must had a spontaneous vaginal delivery between the 38th and 42nd weeks of pregnancy,
- must had a healthy newborn baby with 2500 gr and over
Exclusion Criteria:
- postpartum obstetric complications
- psychiatric disease history before or during pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
|
|
Experimental: Exercises Group
|
The women in the experimental group were given information about the benefits of exercises done in the postpartum period, the time to start these exercises, and the exercises to be conducted in three different phases (mild, medium, severe).
The first physical exercise practice was done in the FHC together.
In line with the recommendations by ACOG (2015), the women were told to do mild and medium level exercises in the first two weeks, at least five days in a week and at least half an hour daily (ACOG, 2015).
They were also told that they should do medium and severe level exercises in the following two weeks.
They were asked to mark on the form what time, how long, and at what level they did the exercises every day.
The education booklet that included this information and the visuals of the exercises were given to the women in the experimental group.
In addition, the women were called once a week in order to check whether the training was applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of exercise
Time Frame: 4 week
|
questionnaire and scale, Edinburgh Postpartum Depression Scale (EPDS) The screening scale, developed by Cox et al. (1987), aimed to identify depression risk in women in the postpartum period.
It's a self-report scale that is composed of 10 items aiming to measure the individual's psychological state within the past 7 days.
Each item is rated on a four-point Likert scale between 0 and 3 ("Yes, all the time", "Yes, most of the time", "No, not very often", and "No, not at all".
Total score ranges between 0 and 30.
Higher scores indicate the severity of depression.
Aydin et al. (2004) performed the reliability and validity of the scale and identified the cut-off point for Turkish women as 12.5
|
4 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- AdıyamanUniversty
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Depression, Postpartum
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
-
University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
-
University of MinnesotaNational Institute of Mental Health (NIMH)Completed
-
Sage TherapeuticsCompletedSevere Postpartum DepressionUnited States
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
Gazi UniversityCompletedPostpartum Depression | Postpartum AdaptationTurkey
-
British Columbia Children's HospitalActive, not recruiting
-
University of RochesterMae Stone Goode FoundationCompletedPostpartum Depression | Postpartum AnxietyUnited States
-
Hacettepe UniversityCompletedQuality of Life | Postpartum Depression | Nursing Caries | Nurse's Role | Postpartum Disorder | Postpartum AnxietyTurkey
Clinical Trials on Exercises
-
Derya AzimCompletedStroke | Physiotherapy and RehabilitationTurkey
-
Inonu UniversityBurcu TaluEnrolling by invitation
-
Riphah International UniversityRecruiting
-
National Institute of Rehabilitation, MexicoCompletedChronic Low Back Pain | Degenerative SpondylolisthesisMexico
-
Delta University for Science and TechnologyCompletedChronic Mechanical Low Back PainEgypt
-
Firat UniversityRecruiting
-
Riphah International UniversityRecruitingPrimary DysmenorrheaPakistan
-
Cumhuriyet UniversityActive, not recruiting
-
Riphah International UniversityCompletedFrozen ShoulderPakistan