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Mindfulness Breath Awareness Meditation and Preeclampsia

The Effect of Mindfulness Breath Awareness Meditation on Health Profile, Vital Signs, and Fetal Heart Rate in Pregnant Women Diagnosed With Preeclampsia

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06065709
Enrollment
66
Registered
2023-10-04
Start date
2023-10-01
Completion date
2024-04-01
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mindfulness Breath Awareness Meditation, Preeclampsia

Keywords

Mindfulness breath awareness meditation, Preeclampsia, Pregnant women, Health profile, Vital signs, Fetal heart rate

Brief summary

The effect of mindfulness breath awareness meditation on health profile, vital signs, and fetal heart rate in pregnant women with preeclampsia

Detailed description

The aim of this study is to determine the effect of mindfulness breath awareness meditation (MBAM) on health profile, vital signs, and fetal heart rate in pregnant women with preeclampsia. Sample size: * There will be two groups in the study. * Experiment group is breath awareness meditation group. * The sample size of the study is 66 women. * The sample size will be divided into two and 33 women will be randomly assigned to each group. Application time: * The application will be started after the pregnant women diagnosed with pre-eclampsia is admitted to the Perinatology service. * It will be applied total nine times in once every eight hours during the 72 hours that the pregnant women diagnosed with 20 minutes. * Only mindfulness breath awareness meditation (MBAM) will not be applied to the control group. Care and follow-up will be performed in parallel with the individuals in the experimental group. Data Collection Tools: * Descriptive Information Form * Nottingham Health Profile Scale Measurement time: * Pregnant women will fill in the Introductory Information Form before the first application. * Each session of mindfulness breath awareness meditation practice will 20 minutes. * Pregnant women will fill the Nottingham Health Profile Scale before the first application. It will then be refilled at the same time every 24 hours for 72 hours. The Nottingham Health Profile will be completed a total of four times. * Vital signs (systolic and diastolic blood pressure, body temperature, pulse, respiration, oxygen saturation) will be measured immediately before the first application. They will then be refilled at the same time every 24 hours for 72 hours. Vital signs will be completed a total of four times. * Fetal heart rate and fetal movement count will be measured immediately before the first application. They will then be refilled at the same time every 24 hours for 72 hours. Fetal heart rate and fetal movement count will be assessed by Non-stress Testing (NST). The pregnant woman will undergo NST for 20 minutes.

Interventions

BEHAVIORALMindfulness breath awareness meditation

Mindfulness breath awareness meditation

Sponsors

Aysegul Kilicli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

randomised controlled trial

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* pregnant women who is admitted to the Perinatology Service of the hospital with the diagnosis of preeclampsia, * who is 19 to 49 years old, * who is 20 and over weeks of gestation, * who followes by at least three days of hospitalization in the ward.

Exclusion criteria

* Pregnant women who do not meet the inclusion criteria and who voluntarily withdraw at any stage after inclusion will be excluded from the study.

Design outcomes

Primary

MeasureTime frameDescription
Oxygen saturationIt will be evaluated before the first application and then every 24 hours for a total of 4 timesOxygen saturation
Diastolic blood pressureIt will be evaluated before the first application and then every 24 hours for a total of 4 timesDiastolic blood pressure
Respiratory rateIt will be evaluated before the first application and then every 24 hours for a total of 4 timesRespiratory rate
Nottingham Health ProfileIt will be evaluated before the first application and then every 24 hours for a total of 4 timesNottingham Health Profile The scale consists of 38 questions and 6 sub-dimensions. The scale consists of 8 questions on physical activity (PA), 8 questions on pain (P), 5 questions on sleep (S), 3 questions on energy level (EL), 9 questions on emotional reactions (ER), 5 questions on social isolation (SI). Questions are answered as 'yes' or 'no', item score calculations in each sub-dimension differ, the best score that can be obtained from each sub-dimension is '0' and the worst score is '100'. The minimum score that can be obtained from the whole scale is 0 and the maximum score is 600. Quality of life improves as the score decreases.
Fetal heart rateIt will be evaluated before the first application and then every 24 hours for a total of 4 timesFetal heart rate
Body temperatureIt will be evaluated before the first application and then every 24 hours for a total of 4 timesBody temperature
PulseIt will be evaluated before the first application and then every 24 hours for a total of 4 timesPulse
Systolic blood pressureIt will be evaluated before the first application and then every 24 hours for a total of 4 timesSystolic blood pressure

Secondary

MeasureTime frameDescription
Nottingham Health Profile subdimensionsIt will be evaluated before the first application and then every 24 hours for a total of 4 timesNottingham Health Profile subdimensions physical activity, pain, sleep, energy, emotional reactions, and social isolation
fetal movement countIt will be evaluated before the first application and then every 24 hours for a total of 4 timesfetal movement count

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026