Clinical trial NCT06065709: Mindfulness Breath Awareness Meditation and Preeclampsia
Official title: The Effect of Mindfulness Breath Awareness Meditation on Health Profile, Vital Signs, and Fetal Heart Rate in Pregnant Women Diagnosed With Preeclampsia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mindfulness Breath Awareness Meditation
Preeclampsia
Keywords: Mindfulness breath awareness meditation
Preeclampsia
Pregnant women
Health profile
Vital signs
Fetal heart rate
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 66
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised controlled trial
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nottingham Health Profile
timeFrame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
measure: Fetal heart rate
timeFrame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
measure: Body temperature
timeFrame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
measure: Pulse
timeFrame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
measure: Systolic blood pressure
timeFrame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
measure: Diastolic blood pressure
timeFrame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
measure: Respiratory rate
timeFrame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
measure: Oxygen saturation
timeFrame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Secondary outcomes:
measure: fetal movement count
timeFrame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
measure: Nottingham Health Profile subdimensions
timeFrame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Şanlıurfa training and research hospital
state: Eyalet/Yerleşke
Study officials:
References: