Clinical trial NCT05946252: Motor Imagery in High-Risk Pregnants
Official title: Acute Effect of Motor Imagery in High-Risk Pregnants: A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy, High Risk
Lead sponsor: Izmir University of Economics
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized controlled study.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maternal self well-being
timeFrame: at baseline
Secondary outcomes:
measure: Maternal self well-being
timeFrame: immediately after intervention
measure: Maternal heart rate
timeFrame: at baseline
measure: Maternal heart rate
timeFrame: in the 7th minutes of the intervention
measure: Maternal heart rate
timeFrame: immediately after intervention
measure: Maternal blood pressure (systolic pressure)
timeFrame: at baseline
measure: Maternal blood pressure (systolic pressure)
timeFrame: in the 7th minutes of the intervention
measure: Maternal blood pressure (systolic pressure)
timeFrame: immediately after intervention
measure: Maternal blood pressure (diastolic pressure)
timeFrame: at baseline
measure: Maternal blood pressure (diastolic pressure)
timeFrame: in the 7th minutes of the intervention
measure: Maternal blood pressure (diastolic pressure)
timeFrame: immediately after intervention
measure: oxygen saturation
timeFrame: at baseline
measure: oxygen saturation
timeFrame: in the 7th minutes of the intervention
measure: oxygen saturation
timeFrame: immediately after intervention
measure: Fetal Heart Rate
timeFrame: at baseline
measure: Fetal Heart Rate
timeFrame: in the 7th minutes of the intervention
measure: Fetal Heart Rate
timeFrame: immediately after intervention
measure: Uterine contractions severity
timeFrame: at baseline
measure: Uterine contractions severity
timeFrame: in the 7th minutes of the intervention
measure: Uterine contractions severity
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Health Sciences University İzmir Tepecik Education and Research Hospital Gynecology and Obstetrics Clinic
Study officials:
affiliation: Izmir University of Economics
name: Seda Yakıt Yeşilyurt, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: