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

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

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia; Mindfulness Breath Awareness Meditation
• Intervention / Treatment: Behavioral: Mindfulness breath awareness meditation

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Eyalet/Yerleşke
    • Şanlıurfa, Eyalet/Yerleşke, Turkey, 63000
      • Recruiting
      • Sanlıurfa Training and Research Hospital
      • Contact: AYŞEGÜL KILIÇLI, Dr.; Phone Number: (0414) 317 17 17; Email: aysegul_ay_9@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness breath awareness meditation group; 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; Mindfulness breath awareness meditation
No Intervention: control group; only mindfulness breath awareness meditation will not be applied to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
Respiratory rate	Respiratory rate	It will be evaluated before the first application and then every 24 hours for a total of 4 times
Oxygen saturation	Oxygen saturation	It will be evaluated before the first application and then every 24 hours for a total of 4 times

Secondary Outcome Measures

Outcome Measure	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	It will be evaluated before the first application and then every 24 hours for a total of 4 times

Collaborators and Investigators

• Sponsor: Aysegul Kilicli

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 30, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Preeclampsia; Pregnant women; Vital signs; Fetal heart rate; Health profile; Mindfulness breath awareness meditation
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pre-Eclampsia
• Other Study ID Numbers: MEDITATION AND PREECLAMPSİA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No