Motor Imagery in High-Risk Pregnants

Pregnancy, High Risk Clinical Trial

Official title:

Acute Effect of Motor Imagery in High-Risk Pregnants: A Randomized Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05946252
• Other study ID #: IEU_SYY_1
• Status: Completed
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: January 5, 2024

Study information

• Verified date: January 2024
• Source: Izmir University of Economics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 5, 2024
• Est. primary completion date: October 2, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy, High Risk

Intervention

Other:
• Motor imagery
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 breathing
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.

Locations

Country	Name	City	State
Turkey	Health Sciences University Izmir Tepecik Education and Research Hospital Gynecology and Obstetrics Clinic	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Izmir University of Economics

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at baseline
Secondary	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.	immediately after intervention
Secondary	Maternal heart rate	Heart rate measurements will be made with an arm type digital sphygmomanometer.	at baseline
Secondary	Maternal heart rate	Heart rate measurements will be made with an arm type digital sphygmomanometer.	in the 7th minutes of the intervention
Secondary	Maternal heart rate	Heart rate measurements will be made with an arm type digital sphygmomanometer.	immediately after intervention
Secondary	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.	at baseline
Secondary	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.	in the 7th minutes of the intervention
Secondary	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.	immediately after intervention
Secondary	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.	at baseline
Secondary	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.	in the 7th minutes of the intervention
Secondary	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.	immediately after intervention
Secondary	oxygen saturation	Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.	at baseline
Secondary	oxygen saturation	Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.	in the 7th minutes of the intervention
Secondary	oxygen saturation	Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.	immediately after intervention
Secondary	Fetal Heart Rate	Fetal heart rate will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).	at baseline
Secondary	Fetal Heart Rate	Fetal heart rate will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).	in the 7th minutes of the intervention
Secondary	Fetal Heart Rate	Fetal heart rate will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).	immediately after intervention
Secondary	Uterine contractions severity	Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).	at baseline
Secondary	Uterine contractions severity	Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).	in the 7th minutes of the intervention
Secondary	Uterine contractions severity	Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).	immediately after intervention