Motor Imagery in High-Risk Pregnants

Sponsor
Izmir University of Economics (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05946252
Collaborator
(none)
70
1
2
8.9
7.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Motor imagery
  • Other: Diaphragmatic breathing
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a prospective randomized controlled study.This is a prospective randomized controlled study.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Acute Effect of Motor Imagery in High-Risk Pregnants: A Randomized Controlled Pilot Study
Anticipated Study Start Date :
Jul 15, 2023
Anticipated Primary Completion Date :
Dec 10, 2023
Anticipated Study Completion Date :
Apr 10, 2024

Arms and Interventions

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: 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

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.

Other: 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.

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: 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

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Maternal self well-being [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.

Secondary Outcome Measures

  1. Maternal self well-being [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.

  2. Maternal heart rate [at baseline]

    Heart rate measurements will be made with an arm type digital sphygmomanometer.

  3. Maternal heart rate [in the 5th minutes of the intervention]

    Heart rate measurements will be made with an arm type digital sphygmomanometer.

  4. Maternal heart rate [in the 10th minutes of the intervention]

    Heart rate measurements will be made with an arm type digital sphygmomanometer.

  5. Maternal heart rate [immediately after intervention]

    Heart rate measurements will be made with an arm type digital sphygmomanometer.

  6. Maternal blood pressure (systolic pressure) [at baseline]

    Blood pressure measurements will be made with an arm type digital sphygmomanometer. Systolic blood pressure and diastolic blood pressure will be assessed.

  7. Maternal blood pressure (systolic pressure) [in the 5th 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.

  8. Maternal blood pressure (systolic pressure) [in the 10th 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.

  9. Maternal blood pressure (systolic pressure) [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.

  10. Maternal blood pressure (diastolic pressure) [at baseline]

    Blood pressure measurements will be made with an arm type digital sphygmomanometer. Systolic blood pressure and diastolic blood pressure will be assessed.

  11. Maternal blood pressure (diastolic pressure) [in the 5th 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.

  12. Maternal blood pressure (diastolic pressure) [in the 10th 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.

  13. Maternal blood pressure (diastolic pressure) [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.

  14. oxygen saturation [at baseline]

    Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.

  15. oxygen saturation [in the 5th minutes of the intervention]

    Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.

  16. oxygen saturation [in the 10th minutes of the intervention]

    Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.

  17. oxygen saturation [immediately after intervention]

    Finger type pulse oximeter will be attached and peripheral oxygen saturation will be monitored.

  18. Fetal Heart Rate [at baseline]

    Fetal heart rate will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).

  19. Fetal Heart Rate [in the 5th minutes of the intervention]

    Fetal heart rate will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).

  20. Fetal Heart Rate [in the 10th minutes of the intervention]

    Fetal heart rate will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).

  21. Fetal Heart Rate [immediately after intervention]

    Fetal heart rate will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).

  22. Uterine contractions severity [at baseline]

    Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).

  23. Uterine contractions severity [in the 5th minutes of the intervention]

    Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).

  24. Uterine contractions severity [in the 10th minutes of the intervention]

    Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).

  25. Uterine contractions severity [immediately after intervention]

    Uterine contractions severity will be monitored with a cardiotachometer (Philips Avalon Fetal Monitor).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Health Sciences University İzmir Tepecik Education and Research Hospital Gynecology and Obstetrics Clinic İzmir Turkey

Sponsors and Collaborators

  • Izmir University of Economics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seda Yakit Yesilyurt, Lecturer Dr, Izmir University of Economics
ClinicalTrials.gov Identifier:
NCT05946252
Other Study ID Numbers:
  • İEU_SYY_1
First Posted:
Jul 14, 2023
Last Update Posted:
Jul 14, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 14, 2023