Pregnancy, High RiskNCT05946252
Motor Imagery in High-Risk Pregnants
A study testing Motor imagery and Diaphragmatic breathing in people with Pregnancy, High Risk, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the acute effects of motor imagery exercises on fetal heart rate, uterine contractions, maternal heart rate, blood pressure, oxygen saturation and well-being in high-risk pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy, High Risk
- What is being tested?
- Motor imagery and Diaphragmatic breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 5 Jan 2024
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Risky pregnant women who have completed the 12th week of pregnancy, received inpatient treatment and have any of the following risk factors will be included in the study:
- Pregnant women who are at risk for obstetric outcomes such as cervical insufficiency, multiple pregnancy and uncontrolled gestational diabetes, and physical activity restriction is recommended due to these conditions, and exercise is contraindicated,
- Pregnant women with a maternal body mass index above 30, which causes them to be physically inactive
Who cannot join
- Pregnant women who are at risk for obstetric outcomes such as gestational diabetes mellitus and pregnancy-induced hypertension, but physical activity is recommended
- Pregnant women with severe cardiovascular, pulmonary and systemic disorders
- Pregnant women with psychological seizure disorders
- Pregnant women who do not have any mental problems that prevent cooperation and understanding
- Pregnant women with any medical condition that prevents the safe and effective implementation of interventions.
- Pregnant women in other high-risk groups (such as early membrane rupture, placenta previa, preeclampsia) that may have early intervention in terms of obstetric outcomes.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University İzmir Tepecik Education and Research Hospital Gynecology and Obstetrics Clinic
Izmir
About this study
Official title: Acute Effect of Motor Imagery in High-Risk Pregnants: A Randomized Controlled Pilot Study
The aim of this study is to determine the acute effects of motor imagery exercises on fetal heart rate, uterine contractions, maternal heart rate, blood pressure, oxygen saturation and well-being in high-risk pregnant women.
Read the detailed description
Bed rest is often recommended in high-risk pregnant women to prevent complications from reaching dangerous levels.
Pregnant women recommended bed rest can benefit from exercise in order to overcome this process more easily, to reduce the negative consequences of inactivity and to prevent possible risks.
However, there may be differences between the view of high-risk pregnant women and the view of healthy pregnant women. Motor imagery refers to a mental process in which an individual mentally imagines that movement without actually eliciting an active movement. Studies have shown that similar brain regions are activated during movement performance and movement imagery. It has been reported in the literature that progressive relaxation exercises performed under mental/motor imagery guidance in healthy pregnant women and pregnant women lead to an improvement in maternal anxiety, stress and fetal attachment scales and a decrease in maternal systolic/diastolic blood pressure. However, as far as the investigators know, there is no study that applies the exercise protocol that can be given to healthy pregnant women to high-risk pregnant women with motor imagery and examines acute responses on fetal and maternal parameters.
- Conditions
- Pregnancy, High Risk
- Being tested
- Motor imagery, Diaphragmatic breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imageryOther
Motor imagery will be performed according to the PETTLEP (Physical,Environment,Task,Time,Learn,Emotion,Perspective) model for 15 minutes.
- To imagine walking activity in different environments (seaside, beach, walking path).
- The rest activity will be imagined by sitting on a bench.
- Upper extremity strengthening exercises with dumbbells, lower extremity strengthening exercises with elastic band and trunk-oriented bridging, posterior pelvic tilt and table top stabilization exercises will be visualized.
- The rest activity will be imagined by sitting on a bench.
- Imagination will end with homecoming and domestic activities.
Diaphragmatic breathingOther
Diaphragmatic breathing will be shown to pregnant women in the supine position, eyes closed, with one hand on the chest and the other hand on the abdomen. This practice will last for five minutes.
| Study group | Role | What they receive |
|---|---|---|
| Motor Imagery Group | Experimental | Risky pregnant women who have completed the 12th week of pregnancy, received inpatient treatment and have any of the following risk factors will be included in the study:
* Pregnant women who are at risk for obstetric outcomes such as cervical insufficiency, multiple pregnancy and uncontrolled gestational diabetes, and physical activity restriction is recommended due to these conditions, and exercise is contraindicated,
* Pregnant women with a maternal body mass index above 30, which causes them to be physically inactive Receives: Other: Motor imagery; Other: Diaphragmatic breathing |
| Control Group | Active comparator | Risky pregnant women who have completed the 12th week of pregnancy, received inpatient treatment and have any of the following risk factors will be included in the study:
* Pregnant women who are at risk for obstetric outcomes such as cervical insufficiency, multiple pregnancy and uncontrolled gestational diabetes, and physical activity restriction is recommended due to these conditions, and exercise is contraindicated,
* Pregnant women with a maternal body mass index above 30, which causes them to be physically inactive Receives: Other: Diaphragmatic breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal self well-being
Well-being will be assessed on a numbered classification scale-11. '0' indicates worse self well-being, '10' indicates excellent self well-being.
Measured: at baseline
Secondary outcomes (19)
Maternal self well-being
Well-being will be assessed on a numbered classification scale-11. '0' indicates worse self well-being, '10' indicates excellent self well-being.
Measured: immediately after intervention
Maternal heart rate
Heart rate measurements will be made with an arm type digital sphygmomanometer.
Measured: at baseline
Maternal heart rate
Heart rate measurements will be made with an arm type digital sphygmomanometer.
Measured: in the 7th minutes of the intervention
Maternal heart rate
Heart rate measurements will be made with an arm type digital sphygmomanometer.
Measured: immediately after intervention
Maternal blood pressure (systolic pressure)
Blood pressure measurements will be made with an arm type digital sphygmomanometer.
Systolic blood pressure and diastolic blood pressure will be assessed.
Measured: at baseline
Maternal blood pressure (systolic pressure)
Blood pressure measurements will be made with an arm type digital sphygmomanometer.
Systolic blood pressure and diastolic blood pressure will be assessed.
Measured: in the 7th minutes of the intervention
Maternal blood pressure (systolic pressure)
Blood pressure measurements will be made with an arm type digital sphygmomanometer.
Systolic blood pressure and diastolic blood pressure will be assessed.
Measured: immediately after intervention
Maternal blood pressure (diastolic pressure)
Blood pressure measurements will be made with an arm type digital sphygmomanometer.
Systolic blood pressure and diastolic blood pressure will be assessed.
Measured: at baseline
Maternal blood pressure (diastolic pressure)
Blood pressure measurements will be made with an arm type digital sphygmomanometer.
Systolic blood pressure and diastolic blood pressure will be assessed.
Measured: in the 7th minutes of the intervention
Maternal blood pressure (diastolic pressure)
Blood pressure measurements will be made with an arm type digital sphygmomanometer.
Systolic blood pressure and diastolic blood pressure will be assessed.
Measured: immediately after intervention
oxygen saturation
Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.
Measured: at baseline
oxygen saturation
Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.
Measured: in the 7th minutes of the intervention
oxygen saturation
Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.
Measured: immediately after intervention
Fetal Heart Rate
Fetal heart rate will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).
Measured: at baseline
Fetal Heart Rate
Fetal heart rate will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).
Measured: in the 7th minutes of the intervention
Fetal Heart Rate
Fetal heart rate will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).
Measured: immediately after intervention
Uterine contractions severity
Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).
Measured: at baseline
Uterine contractions severity
Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).
Measured: in the 7th minutes of the intervention
Uterine contractions severity
Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Aug 2023
- Primary completion2 Oct 2023
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, High RiskStudies 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
- Model description
- This is a prospective randomized controlled study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Yakit Yesilyurt, Izmir University of Economics
- Investigators
- Seda Yakıt Yeşilyurt, PT, PhD, Principal investigator, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946252
- Sponsor's protocol ID
- İEU_SYY_1
- Status last verified
- Jan 2024
- First submitted
- 14 Jun 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Motor Imagery in High-Risk Pregnants: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05946252
- Acronym / sponsor ID
- İEU_SYY_1
- Conditions
- Pregnancy, High Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 14 Jul 2023 (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.
The aim of this study is to determine the acute effects of motor imagery exercises on fetal heart rate, uterine contractions, maternal heart rate, blood pressure, oxygen saturation and well-being in high-risk pregnant women.
Detailed description
Bed rest is often recommended in high-risk pregnant women to prevent complications from reaching dangerous levels.
Pregnant women recommended bed rest can benefit from exercise in order to overcome this process more easily, to reduce the negative consequences of inactivity and to prevent possible risks.
However, there may be differences between the view of high-risk pregnant women and the view of healthy pregnant women. Motor imagery refers to a mental process in which an individual mentally imagines that movement without actually eliciting an active movement. Studies have shown that similar brain regions are activated during movement performance and movement imagery. It has been reported in the literature that progressive relaxation exercises performed under mental/motor imagery guidance in healthy pregnant women and pregnant women lead to an improvement in maternal anxiety, stress and fetal attachment scales and a decrease in maternal systolic/diastolic blood pressure. However, as far as the investigators know, there is no study that applies the exercise protocol that can be given to healthy pregnant women to high-risk pregnant women with motor imagery and examines acute responses on fetal and maternal parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Motor Imagery Group | Experimental | Other: Motor imagery, Other: Diaphragmatic breathingRisky pregnant women who have completed the 12th week of pregnancy, received inpatient treatment and have any of the following risk factors will be included in the study: * Pregnant women who are at risk for obstetric outcomes such as cervical insufficiency, multiple pregnancy and uncontrolled gestational diabetes, and physical activity restriction is recommended due to these conditions, and exercise is contraindicated, * Pregnant women with a maternal body mass index above 30, which causes them to be physically inactive |
| Control Group | Active comparator | Other: Diaphragmatic breathingRisky pregnant women who have completed the 12th week of pregnancy, received inpatient treatment and have any of the following risk factors will be included in the study: * Pregnant women who are at risk for obstetric outcomes such as cervical insufficiency, multiple pregnancy and uncontrolled gestational diabetes, and physical activity restriction is recommended due to these conditions, and exercise is contraindicated, * Pregnant women with a maternal body mass index above 30, which causes them to be physically inactive |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Risky pregnant women who have completed the 12th week of pregnancy, received inpatient treatment and have any of the following risk factors will be included in the study:
- Pregnant women who are at risk for obstetric outcomes such as cervical insufficiency, multiple pregnancy and uncontrolled gestational diabetes, and physical activity restriction is recommended due to these conditions, and exercise is contraindicated,
- Pregnant women with a maternal body mass index above 30, which causes them to be physically inactive
Key exclusion criteria (6 listed)
- Pregnant women who are at risk for obstetric outcomes such as gestational diabetes mellitus and pregnancy-induced hypertension, but physical activity is recommended
- Pregnant women with severe cardiovascular, pulmonary and systemic disorders
- Pregnant women with psychological seizure disorders
- Pregnant women who do not have any mental problems that prevent cooperation and understanding
- Pregnant women with any medical condition that prevents the safe and effective implementation of interventions.
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 |
|---|---|---|
| Motor imageryMotor imagery will be performed according to the PETTLEP (Physical,Environment,Task,Time,Learn,Emotion,Perspective) model for 15 minutes. 1. To imagine walking activity in different environments (seaside, beach, walking path). 2. The rest activity will be imagined by sitting on a bench. 3. Upper extremity strengthening exercises with dumbbells, lower extremity strengthening exercises with elastic band and trunk-oriented bridging, posterior pelvic tilt and table top stabilization exercises will be visualized. 4. The rest activity will be imagined by sitting on a bench. 5. Imagination will end with homecoming and domestic activities. | Other | Motor Imagery Group |
| Diaphragmatic breathingDiaphragmatic breathing will be shown to pregnant women in the supine position, eyes closed, with one hand on the chest and the other hand on the abdomen. This practice will last for five minutes. | Other | Control Group, Motor Imagery Group |
Primary outcome
Maternal self well-being
Time frame: at baseline
Well-being will be assessed on a numbered classification scale-11. '0' indicates worse self well-being, '10' indicates excellent self well-being.
19 secondary outcomes
Maternal self well-being
Time frame: immediately after intervention
Maternal heart rate
Time frame: at baseline
Maternal heart rate
Time frame: in the 7th minutes of the intervention
Maternal heart rate
Time frame: immediately after intervention
Maternal blood pressure (systolic pressure)
Time frame: at baseline
Maternal blood pressure (systolic pressure)
Time frame: in the 7th minutes of the intervention
Maternal blood pressure (systolic pressure)
Time frame: immediately after intervention
Maternal blood pressure (diastolic pressure)
Time frame: at baseline
Maternal blood pressure (diastolic pressure)
Time frame: in the 7th minutes of the intervention
Maternal blood pressure (diastolic pressure)
Time frame: immediately after intervention
oxygen saturation
Time frame: at baseline
oxygen saturation
Time frame: in the 7th minutes of the intervention
oxygen saturation
Time frame: immediately after intervention
Fetal Heart Rate
Time frame: at baseline
Fetal Heart Rate
Time frame: in the 7th minutes of the intervention
Fetal Heart Rate
Time frame: immediately after intervention
Uterine contractions severity
Time frame: at baseline
Uterine contractions severity
Time frame: in the 7th minutes of the intervention
Uterine contractions severity
Time frame: immediately after intervention
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 Jan 2024.
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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.
Seda Yakıt Yeşilyurt, PT, PhD principal investigator
Izmir University of Economics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor imagery and Diaphragmatic breathing in people with Pregnancy, High Risk, run by Izmir University of Economics 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 3 inclusion and 6 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 Jan 2024. 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?
Maternal self well-being (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2024; AzTrials last refreshed its copy on 2 Nov 2026.