- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05946252
Motor Imagery in High-Risk Pregnants
Acute Effect of Motor Imagery in High-Risk Pregnants: A Randomized Controlled Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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İzmir, Turkey
- Health Sciences University İzmir Tepecik Education and Research Hospital Gynecology and Obstetrics Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motor Imagery Group
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:
|
Motor imagery will be performed according to the PETTLEP (Physical,Environment,Task,Time,Learn,Emotion,Perspective) model for 15 minutes.
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.
|
|
Active Comparator: Control Group
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:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
at baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal self well-being
Time Frame: immediately after intervention
|
Well-being will be assessed on a numbered classification scale-11.
'0' indicates worse self well-being, '10' indicates excellent self well-being.
|
immediately after intervention
|
|
Maternal heart rate
Time Frame: at baseline
|
Heart rate measurements will be made with an arm type digital sphygmomanometer.
|
at baseline
|
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Maternal heart rate
Time Frame: immediately after intervention
|
Heart rate measurements will be made with an arm type digital sphygmomanometer.
|
immediately after intervention
|
|
Maternal blood pressure (systolic pressure)
Time Frame: at baseline
|
Blood pressure measurements will be made with an arm type digital sphygmomanometer. Systolic blood pressure and diastolic blood pressure will be assessed. |
at baseline
|
|
Maternal blood pressure (systolic pressure)
Time Frame: immediately after intervention
|
Blood pressure measurements will be made with an arm type digital sphygmomanometer. Systolic blood pressure and diastolic blood pressure will be assessed. |
immediately after intervention
|
|
Maternal blood pressure (diastolic pressure)
Time Frame: at baseline
|
Blood pressure measurements will be made with an arm type digital sphygmomanometer. Systolic blood pressure and diastolic blood pressure will be assessed. |
at baseline
|
|
Maternal blood pressure (diastolic pressure)
Time Frame: immediately after intervention
|
Blood pressure measurements will be made with an arm type digital sphygmomanometer. Systolic blood pressure and diastolic blood pressure will be assessed. |
immediately after intervention
|
|
oxygen saturation
Time Frame: at baseline
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Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.
|
at baseline
|
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oxygen saturation
Time Frame: immediately after intervention
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Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.
|
immediately after intervention
|
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Fetal Heart Rate
Time Frame: at baseline
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Fetal heart rate will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).
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at baseline
|
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Fetal Heart Rate
Time Frame: immediately after intervention
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Fetal heart rate will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).
|
immediately after intervention
|
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Uterine contractions severity
Time Frame: at baseline
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Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).
|
at baseline
|
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Uterine contractions severity
Time Frame: immediately after intervention
|
Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).
|
immediately after intervention
|
|
Maternal heart rate
Time Frame: in the 7th minutes of the intervention
|
Heart rate measurements will be made with an arm type digital sphygmomanometer.
|
in the 7th minutes of the intervention
|
|
Maternal blood pressure (systolic pressure)
Time Frame: in the 7th minutes of the intervention
|
Blood pressure measurements will be made with an arm type digital sphygmomanometer. Systolic blood pressure and diastolic blood pressure will be assessed. |
in the 7th minutes of the intervention
|
|
Maternal blood pressure (diastolic pressure)
Time Frame: in the 7th minutes of the intervention
|
Blood pressure measurements will be made with an arm type digital sphygmomanometer. Systolic blood pressure and diastolic blood pressure will be assessed. |
in the 7th minutes of the intervention
|
|
oxygen saturation
Time Frame: in the 7th minutes of the intervention
|
Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.
|
in the 7th minutes of the intervention
|
|
Fetal Heart Rate
Time Frame: in the 7th minutes of the intervention
|
Fetal heart rate will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).
|
in the 7th minutes of the intervention
|
|
Uterine contractions severity
Time Frame: in the 7th minutes of the intervention
|
Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).
|
in the 7th minutes of the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seda Yakıt Yeşilyurt, PT, PhD, Izmir University of Economics
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- İEU_SYY_1
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.
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