Mindfulness Breath Awareness Meditation and Preeclampsia

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06065709
• Other study ID #: MEDITATION AND PREECLAMPSIA
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: March 2024
• Source: University of Gaziantep
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Behavioral:
• Mindfulness breath awareness meditation
Mindfulness breath awareness meditation

Locations

Country	Name	City	State
Turkey	Sanliurfa training and research hospital	Sanliurfa	Eyalet/Yerleske

Sponsors (1)

Lead Sponsor	Collaborator
Aysegul Kilicli

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Body temperature	Body temperature	It will be evaluated before the first application and then every 24 hours for a total of 4 times
Primary	Pulse	Pulse	It will be evaluated before the first application and then every 24 hours for a total of 4 times
Primary	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
Primary	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
Primary	Respiratory rate	Respiratory rate	It will be evaluated before the first application and then every 24 hours for a total of 4 times
Primary	Oxygen saturation	Oxygen saturation	It will be evaluated before the first application and then every 24 hours for a total of 4 times
Secondary	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
Secondary	Nottingham Health Profile subdimensions	Nottingham Health Profile subdimensions physical activity, pain, sleep, energy, emotional reactions, and social isolation	It will be evaluated before the first application and then every 24 hours for a total of 4 times