NCT05946252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

June 14, 2023

Last Update Submit

January 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (19)

  • Maternal self well-being

    immediately after intervention

  • Maternal heart rate

    at baseline

  • Maternal heart rate

    in the 7th minutes of the intervention

  • Maternal heart rate

    immediately after intervention

  • Maternal blood pressure (systolic pressure)

    at baseline

  • +14 more secondary outcomes

Study Arms (2)

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

Other: Motor imageryOther: 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

Other: Diaphragmatic breathing

Interventions

Motor 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.

Motor Imagery Group

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.

Control GroupMotor Imagery Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences University İzmir Tepecik Education and Research Hospital Gynecology and Obstetrics Clinic

Izmir, Turkey (Türkiye)

Location

Study Officials

  • Seda Yakıt Yeşilyurt, PT, PhD

    Izmir University of Economics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a prospective randomized controlled study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Dr

Study Record Dates

First Submitted

June 14, 2023

First Posted

July 14, 2023

Study Start

August 1, 2023

Primary Completion

October 2, 2023

Study Completion

January 5, 2024

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations