PregnancyNCT05305716
Online Pilates Training on Pregnant Women
A study testing Online Pilates Training in people with Pregnancy and COVID-19, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- What is being tested?
- Online Pilates Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Nov 2021to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-35 years of age
- Voluntarily participate in research to accept
- 12-28 weeks of pregnancy
- Singleton pregnancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Medipol University
Altındağ, Ankara, 06050
About this study
Official title: Effects of Online Pilates Training on Pregnant Women During the COVID-19 Pandemic: A Randomized Controlled Trial
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.
Read the detailed description
Although there are studies investigating the effectiveness of telerehabilitation in the literature, no online study has been found on pregnancy. The pandemic process reduces the rate of participation of pregnant women in face-to-face exercises, causing physical activity levels to decrease further. Therefore, there is a need for studies on the pregnancy process in the field of telerehabilitation. This study aims to understand how the depression, anxiety and fear of childbirth levels of pregnant women who do pilates online with a physiotherapist during the pandemic process and to bring a new approach to the field of tele-rehabilitation.
The investigators conducted the study at Ankara Medipol University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation. This study was conducted by the principles set out in the Declaration of Helsinki. Fifty-three pregnant women aged 20-35, who completed the first trimester and had a single baby pregnancy, were included in the study, conducted under a specialist obstetrician's guidance. The exclusion criteria for this study were: multiple pregnancies; history of cardiovascular diseases, medical complications (hemorrhage, preeclampsia, placenta previa etc.) and/or cognitive disorders; contraindication for physical exercise (eg: having severe other musculoskeletal disease, high risk pregnancies, balance deficiencies); and participating in other exercises or physiotherapy programs.
- Procedures The investigators assessed the participants by an experienced physiotherapist, who was blind to the randomization, at the start of the study and after the 8-week training. The group on which they depended was not disclosed to the participants until the end of the baseline evaluation. The investigators used a computer program for randomization and randomly placed individuals who completed the initial assessment into the online pilates group (OPG) or control group (CG). The investigators performed the Pilates exercises online, under the supervision of a certified physiotherapist with 10 years of experience. The investigators asked the individuals not to inform the evaluator of their involvement in the training during the last evaluation. Before the study, the investigators explained the purpose and content of the study to the participants and obtained written informed consent from all pregnant women to participate in the study.
- Intervention Online pilates training was done by an Australian Pilates and Physiotherapy Institute certified and experienced Ph.D. Physiotherapist Halil Ibrahim Bulguroglu lasted a total of 8 weeks, 2 days a week for 1 h. Microsoft Teams program was used to perform the exercises online. The investigators divided the individuals in the Pilates exercise group into seven smaller groups of 3 or 4 to verify whether they correctly did the exercises. In this study, the investigators organized a program to include 15 min of warm-up, 30 min of Pilates exercises, and 15 min of cooling and stretching exercises, and the exercises were done in 10 repetitions. The exercise program recommended by the Australian Pilates and Physiotherapy Institute during pregnancy was used in the training. During the Pilates exercises, investigators described the exercises with different visual simulation techniques, and exercises were done together with Pilates breathing. The intensity of the exercises was increased by using different positions and elastic bands. The resistance was increased by starting with the red Therabant and switching to the blue band after two weeks. If the new resistance amount was challenging for the patient, the exercises were continued with the same color band for one more week. Stretching exercises and posture exercises were used during the cooling period. The subjects in the online pilates group were informed about side effects such as shortness of breath, dizziness, headache, muscle pain, and weakness. They were asked to stop exercising when there were any side effects.
The control group was given breathing and relaxation exercises, which they would do two days a week for eight weeks, in the form of a home program. Diaphragmatic breathing and respiratory control were given as breathing exercises.
It was stated that after the study was completed, pregnant women in the control group could also participate in the online exercise program. 6 pregnant women in the control group participated in the online pilates program after the study.
- Outcome measurements The pregnant women included in the study were evaluated with data collection forms filled with an online questionnaire twice, before and after the training programs. The investigators recorded demographic information (age, body weight, height, body mass index) of the participants.
The investigators evaluated depression with the Edinburgh Postpartum Depression Scale (EPDS). In a study conducted in 2009, it was reported that EPDS is a reliable tool in the evaluation of depressive symptoms in pregnancy. 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.
The investigators assessed anxiety with the State-Trait Anxiety Inventory (STAI Form 1-2). The scale is a Likert-type scale consisting of 20 questions that measure 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.
The investigators evaluated Fear of Birth with the Wijma Birth expectation/Experience Questionnaire (W-DEQ). The W-DEQ was developed to measure the nature of the fear of childbirth during and after labor by asking women questions about their expectations before birth (version A) and their experiences after birth (version B).
Data availability The data associated with the paper are not publicly available but are available from the corresponding author on reasonable request.
- Statistical analysis The investigators performed statistical analysis by using SPSS software, version 21 (SPSS Inc. Chicago, IL, USA). The normal distribution of variables was determined using histograms, probability plots, and a Shapiro-Wilk test. Because of an abnormal distribution, median and interquartile range (IQR) were used for descriptive statistics. Numerical variables showing normal distribution were shown as mean±standard deviation. The investigators used a Mann-Whitney U test to compare baseline and change values between groups. The investigators used Wilcoxon Test for comparing baseline values within the group and values after 8 weeks. The level of significance was set at p < 0.05 for all analyses. The effect sizes were evaluated according to Cohen's d standards within the pre-post differences. Effect size results were interpreted as small (≥ 0.2), medium (≥ 0.5), or large (≥ 0.8) according to guidelines.
- Being tested
- Online Pilates Training, Control group
- Keywords
- Pilates exercises, Pregnant, Depression, Anxiety
- Medical subject headings
- COVID-19, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Pilates TrainingOther
The group that received telerehabilitation and telerehabilitation-based pilates training.
Control groupOther
The group who received breathing and relaxation exercises with a home program.
| Study group | Role | What they receive |
|---|---|---|
| online pilates group | Experimental | Online pilates training was done for a total of 8 weeks, 2 days a week for 1 hour. Microsoft Teams program was used to perform the exercises online. The investigators divided the individuals in the online pilates exercise group into seven smaller groups of 3 or 4 to verify whether they correctly did the exercises. A program including 15 minutes of warm-up, 30 minutes of Pilates exercises and 15 minutes of cooling and stretching exercises was arranged for the online pilates group and the exercises were performed as 10 repetitions. The exercise program recommended by the Australian Pilates and Physiotherapy Institute during pregnancy was used in the online training. Receives: Other: Online Pilates Training |
| control group | Active comparator | The control group was given breathing and relaxation exercises, which they would do two days a week for eight weeks, in the form of a home program. Diaphragmatic breathing and respiratory control were given as breathing exercises. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessment will be conducted before the intervention
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.
Measured: Assessment will be conducted immediately after the intervention
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.
Measured: Assessment will be conducted before the intervention
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.
Measured: Assessment will be conducted immediately after the intervention
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.
Measured: Assessment will be conducted before the intervention
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
Measured: Assessment will be conducted immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start3 Nov 2021
- Primary completion10 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ibrahim Bulguroglu, Ankara Medipol University
- Investigators
- HALIL IB BULGUROGLU, PHD PT, Principal investigator, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305716
- Sponsor's protocol ID
- 1
- Status last verified
- Mar 2022
- First submitted
- 22 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34742627Cox 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. doi: 10.1192/bjp.150.6.782.
PubMed 3651732Bunevicius 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.
PubMed 19845492Wijma 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. doi: 10.3109/01674829809048501.
PubMed 9638601Suner-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. 2022 Oct;191(5):2133-2139. doi: 10.1007/s11845-021-02840-8. Epub 2021 Oct 30.
PubMed 34716884Bulguroglu M, Bulguroglu HI. The effects of online pilates on the mood and fear of birth of pregnant women: a randomized controlled study. Sci Rep. 2024 Jul 12;14(1):16143. doi: 10.1038/s41598-024-67290-5.
PubMed 38997441
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Online Pilates Training on Pregnant Women During the COVID-19 Pandemic: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05305716
- Acronym / sponsor ID
- 1
- Keywords
- Pilates exercises, Pregnant, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Although there are studies investigating the effectiveness of telerehabilitation in the literature, no online study has been found on pregnancy. The pandemic process reduces the rate of participation of pregnant women in face-to-face exercises, causing physical activity levels to decrease further. Therefore, there is a need for studies on the pregnancy process in the field of telerehabilitation. This study aims to understand how the depression, anxiety and fear of childbirth levels of pregnant women who do pilates online with a physiotherapist during the pandemic process and to bring a new approach to the field of tele-rehabilitation.
The investigators conducted the study at Ankara Medipol University, Faculty of Health Sciences, Department of Physical Therapy and Rehabilitation. This study was conducted by the principles set out in the Declaration of Helsinki. Fifty-three pregnant women aged 20-35, who completed the first trimester and had a single baby pregnancy, were included in the study, conducted under a specialist obstetrician's guidance. The exclusion criteria for this study were: multiple pregnancies; history of cardiovascular diseases, medical complications (hemorrhage, preeclampsia, placenta previa etc.) and/or cognitive disorders; contraindication for physical exercise (eg: having severe other musculoskeletal disease, high risk pregnancies, balance deficiencies); and participating in other exercises or physiotherapy programs.
- Procedures The investigators assessed the participants by an experienced physiotherapist, who was blind to the randomization, at the start of the study and after the 8-week training. The group on which they depended was not disclosed to the participants until the end of the baseline evaluation. The investigators used a computer program for randomization and randomly placed individuals who completed the initial assessment into the online pilates group (OPG) or control group (CG). The investigators performed the Pilates exercises online, under the supervision of a certified physiotherapist with 10 years of experience. The investigators asked the individuals not to inform the evaluator of their involvement in the training during the last evaluation. Before the study, the investigators explained the purpose and content of the study to the participants and obtained written informed consent from all pregnant women to participate in the study.
- Intervention Online pilates training was done by an Australian Pilates and Physiotherapy Institute certified and experienced Ph.D. Physiotherapist Halil Ibrahim Bulguroglu lasted a total of 8 weeks, 2 days a week for 1 h. Microsoft Teams program was used to perform the exercises online. The investigators divided the individuals in the Pilates exercise group into seven smaller groups of 3 or 4 to verify whether they correctly did the exercises. In this study, the investigators organized a program to include 15 min of warm-up, 30 min of Pilates exercises, and 15 min of cooling and stretching exercises, and the exercises were done in 10 repetitions. The exercise program recommended by the Australian Pilates and Physiotherapy Institute during pregnancy was used in the training. During the Pilates exercises, investigators described the exercises with different visual simulation techniques, and exercises were done together with Pilates breathing. The intensity of the exercises was increased by using different positions and elastic bands. The resistance was increased by starting with the red Therabant and switching to the blue band after two weeks. If the new resistance amount was challenging for the patient, the exercises were continued with the same color band for one more week. Stretching exercises and posture exercises were used during the cooling period. The subjects in the online pilates group were informed about side effects such as shortness of breath, dizziness, headache, muscle pain, and weakness. They were asked to stop exercising when there were any side effects.
The control group was given breathing and relaxation exercises, which they would do two days a week for eight weeks, in the form of a home program. Diaphragmatic breathing and respiratory control were given as breathing exercises.
It was stated that after the study was completed, pregnant women in the control group could also participate in the online exercise program. 6 pregnant women in the control group participated in the online pilates program after the study.
- Outcome measurements The pregnant women included in the study were evaluated with data collection forms filled with an online questionnaire twice, before and after the training programs. The investigators recorded demographic information (age, body weight, height, body mass index) of the participants.
The investigators evaluated depression with the Edinburgh Postpartum Depression Scale (EPDS). In a study conducted in 2009, it was reported that EPDS is a reliable tool in the evaluation of depressive symptoms in pregnancy. 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.
The investigators assessed anxiety with the State-Trait Anxiety Inventory (STAI Form 1-2). The scale is a Likert-type scale consisting of 20 questions that measure 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.
The investigators evaluated Fear of Birth with the Wijma Birth expectation/Experience Questionnaire (W-DEQ). The W-DEQ was developed to measure the nature of the fear of childbirth during and after labor by asking women questions about their expectations before birth (version A) and their experiences after birth (version B).
Data availability The data associated with the paper are not publicly available but are available from the corresponding author on reasonable request.
- Statistical analysis The investigators performed statistical analysis by using SPSS software, version 21 (SPSS Inc. Chicago, IL, USA). The normal distribution of variables was determined using histograms, probability plots, and a Shapiro-Wilk test. Because of an abnormal distribution, median and interquartile range (IQR) were used for descriptive statistics. Numerical variables showing normal distribution were shown as mean±standard deviation. The investigators used a Mann-Whitney U test to compare baseline and change values between groups. The investigators used Wilcoxon Test for comparing baseline values within the group and values after 8 weeks. The level of significance was set at p < 0.05 for all analyses. The effect sizes were evaluated according to Cohen's d standards within the pre-post differences. Effect size results were interpreted as small (≥ 0.2), medium (≥ 0.5), or large (≥ 0.8) according to guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| online pilates group | Experimental | Other: Online Pilates TrainingOnline pilates training was done for a total of 8 weeks, 2 days a week for 1 hour. Microsoft Teams program was used to perform the exercises online. The investigators divided the individuals in the online pilates exercise group into seven smaller groups of 3 or 4 to verify whether they correctly did the exercises. A program including 15 minutes of warm-up, 30 minutes of Pilates exercises and 15 minutes of cooling and stretching exercises was arranged for the online pilates group and the exercises were performed as 10 repetitions. The exercise program recommended by the Australian Pilates and Physiotherapy Institute during pregnancy was used in the online training. |
| control group | Active comparator | Other: Control groupThe control group was given breathing and relaxation exercises, which they would do two days a week for eight weeks, in the form of a home program. Diaphragmatic breathing and respiratory control were given as breathing exercises. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 20-35 years of age
- Voluntarily participate in research to accept
- 12-28 weeks of pregnancy
- Singleton pregnancy
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Pilates TrainingThe group that received telerehabilitation and telerehabilitation-based pilates training. | Other | online pilates group |
| Control groupThe group who received breathing and relaxation exercises with a home program. | Other | control group |
Primary outcome
Depression- Baseline
Time frame: Assessment will be conducted before the 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.
Depression-Post intervention
Time frame: Assessment will be conducted immediately after the 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.
Anxiety- Baseline
Time frame: Assessment will be conducted before the 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.
Anxiety-Post intervention
Time frame: Assessment will be conducted immediately after the 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.
Fear of Childbirth- Baseline
Time frame: Assessment will be conducted before the 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.
Fear of Childbirth-Post intervention
Time frame: Assessment will be conducted immediately after the 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 34742627Arundell 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.
- Background: PubMed 3651732Cox 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. doi: 10.1192/bjp.150.6.782.
- Background: PubMed 19845492Bunevicius 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.
- Background: PubMed 9638601Wijma 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. doi: 10.3109/01674829809048501.
- Results publication: PubMed 34716884Suner-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. 2022 Oct;191(5):2133-2139. doi: 10.1007/s11845-021-02840-8. Epub 2021 Oct 30.
- Derived from this study: PubMed 38997441Bulguroglu M, Bulguroglu HI. The effects of online pilates on the mood and fear of birth of pregnant women: a randomized controlled study. Sci Rep. 2024 Jul 12;14(1):16143. doi: 10.1038/s41598-024-67290-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HALIL IB BULGUROGLU, PHD PT principal investigator
Ankara Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Pilates Training in people with Pregnancy and COVID-19, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression- Baseline (time frame: Assessment will be conducted before the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05305716, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.