Mindfulness Breath Awareness Meditation and Preeclampsia | NCT06065709

NCT06065709

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mindfulness breath awareness meditation group	Experimental	Mindfulness breath awareness meditation will be performed nine times in total, once every eight hours within 72 hours, to the pregnant woman who is hospitalised in the perinatology service of the hospital with the diagnosis of preeclampsia. Each session will last 30 minutes. A 4-stage mindfulness breath awareness meditation includes the following stages: Stage 1 - Body Harmony. Stage 2 - Counting as you Exhale Stage 3 - Counting while Breathing Stage 4 - Sit Still and Witness.	Behavioral: Mindfulness breath awareness meditation
control group	No Intervention	only mindfulness breath awareness meditation will not be applied to the control group.

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness breath awareness meditation	Behavioral	Mindfulness breath awareness meditation	Mindfulness breath awareness meditation group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nottingham Health Profile	Nottingham 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.	It will be evaluated before the first application and then every 24 hours for a total of 4 times
Fetal heart rate	Fetal heart rate	It will be evaluated before the first application and then every 24 hours for a total of 4 times
Body temperature	Body temperature	It will be evaluated before the first application and then every 24 hours for a total of 4 times
Pulse	Pulse	It will be evaluated before the first application and then every 24 hours for a total of 4 times
Systolic blood pressure	Systolic blood pressure	It will be evaluated before the first application and then every 24 hours for a total of 4 times
Diastolic blood pressure	Diastolic blood pressure	It will be evaluated before the first application and then every 24 hours for a total of 4 times

Secondary Outcomes

Measure	Description	Time Frame
fetal movement count	fetal movement count	It will be evaluated before the first application and then every 24 hours for a total of 4 times
Nottingham Health Profile subdimensions	Nottingham Health Profile subdimensions physical activity, pain, sleep, energy, emotional reactions, and social isolation

Eligibility Module

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases