COVID-19 Clinical Trial
Official title:
Effects of Online Pilates Training on Pregnant Women During the COVID-19 Pandemic: A Randomized Controlled Trial
NCT number | NCT05305716 |
Other study ID # | 1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 3, 2021 |
Est. completion date | March 15, 2022 |
Verified date | March 2022 |
Source | Ankara Medipol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Studies show that pregnant women reduce their physical activity levels during pregnancy. The pandemic process causes the physical activities of pregnant women to decrease even more and causes a number of problems. This study aims to reveal effect of online Pilates exercises with a physiotherapist during the pandemic conducted on depression, anxiety and fear of childbirth levels of pregnant women. A total of 50 volunteer pregnant women, 26 online pilates group (OPG) and 24 control group (CG), who met the inclusion criteria of the study, were included in our study randomly. The OPG was given online Pilates exercises by the physiotherapist in groups 2 days a week for 8 weeks, 1 h a day. The CG was given a home program consisting of relaxation and breathing exercises. Depression levels; with the Edinburgh Postpartum Depression Scale, anxiety; with the State-Trait Anxiety Inventory, fear of childbirth; with the Wijma Birth Expectation/Experience Scale version B were evaluated before and after the study by using the online questionnaire form filling method. As a result of the online pilates training, there was an improvement in the all test scores (p<0.05), while no change was observed in the control group (p>0.05). In the light of these results, 8-week online pilates training applied to gain a healthy habit during the pandemic process and increase physical activity levels of the pregnant women has been concluded to be effective in reducing the levels of depression, anxiety and fear of childbirth.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 15, 2022 |
Est. primary completion date | March 10, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 35 Years |
Eligibility | Inclusion Criteria: - 20-35 years of age - Voluntarily participate in research to accept - 12-28 weeks of pregnancy - Singleton pregnancy Exclusion Criteria: - Any cardiovascular, orthopedic, visual, hearing, and perception problems that may affect the results of the research. - Participating in other exercises or physiotherapy programs during the past 6 months. - Multiple pregnancies |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara Medipol University | Altindag | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara Medipol University |
Turkey,
Arundell L, Salmon J, Timperio A, Sahlqvist S, Uddin R, Veitch J, Ridgers ND, Brown H, Parker K. Physical activity and active recreation before and during COVID-19: The Our Life at Home study. J Sci Med Sport. 2022 Mar;25(3):235-241. doi: 10.1016/j.jsams.2021.10.004. Epub 2021 Oct 14. — View Citation
Bunevicius A, Kusminskas L, Pop VJ, Pedersen CA, Bunevicius R. Screening for antenatal depression with the Edinburgh Depression Scale. J Psychosom Obstet Gynaecol. 2009 Dec;30(4):238-43. doi: 10.3109/01674820903230708. — View Citation
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. — View Citation
Suner-Keklik S, Numanoglu-Akbas A, Cobanoglu G, Kafa N, Guzel NA. An online pilates exercise program is effective on proprioception and core muscle endurance in a randomized controlled trial. Ir J Med Sci. 2021 Oct 30. doi: 10.1007/s11845-021-02840-8. [Ep — View Citation
Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998 Jun;19(2):84-97. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depression- Baseline | Edinburgh Postpartum Depression Scale (EPDS) is a self-report scale consisting of 10 items, in a 4-point Likert format. The lowest score that can be obtained from the scale is 0, and the highest score is 30. The cut-off point for EPDS is 13 points. Accordingly, 13 points and above indicate the risk of depression. | Assessment will be conducted before the intervention | |
Primary | Depression-Post intervention | Edinburgh Postpartum Depression Scale (EPDS) is a self-report scale consisting of 10 items, in a 4-point Likert format. The lowest score that can be obtained from the scale is 0, and the highest score is 30. The cut-off point for EPDS is 13 points. Accordingly, 13 points and above indicate the risk of depression. | Assessment will be conducted immediately after the intervention | |
Primary | Anxiety- Baseline | State-Trait Anxiety Inventory is a Likert-type scale consisting of 20 questions that measures state and trait anxiety levels separately. There are two kinds of expressions in the scales. These are called direct and reverse expressions. Direct expressions, negative emotions; reversed expressions express positive emotions. The scores obtained from both scales separately vary between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety. | Assessment will be conducted before the intervention | |
Primary | Anxiety-Post intervention | State-Trait Anxiety Inventory is a Likert-type scale consisting of 20 questions that measures state and trait anxiety levels separately. There are two kinds of expressions in the scales. These are called direct and reverse expressions. Direct expressions, negative emotions; reversed expressions express positive emotions. The scores obtained from both scales separately vary between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety. | Assessment will be conducted immediately after the intervention | |
Primary | Fear of Childbirth- Baseline | The Wijma Birth Expectation/Experience Scale version B was developed to measure the nature of the fear of childbirth during and after labor by asking women questions about their experiences after birth. The minimum score on the scale is 33, the maximum score is 198. | Assessment will be conducted before the intervention | |
Primary | Fear of Childbirth-Post intervention | The Wijma Birth Expectation/Experience Scale version B was developed to measure the nature of the fear of childbirth during and after labor by asking women questions about their experiences after birth. The minimum score on the scale is 33, the maximum score is 198 | Assessment will be conducted immediately after the intervention |
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