Mindfulness Breath Awareness Meditation and Preeclampsia

NCT ID: NCT06065709

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-04-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Mindfulness Breath Awareness Meditation Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomised controlled trial
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness breath awareness meditation

Intervention Type BEHAVIORAL

Mindfulness breath awareness meditation

control group

only mindfulness breath awareness meditation will not be applied to the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness breath awareness meditation

Mindfulness breath awareness meditation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aysegul Kilicli

OTHER

Sponsor Role lead

Responsible Party

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Aysegul Kilicli

gaziantep university health sciences enstitute nursing department PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Şanlıurfa training and research hospital

Sanliurfa, Eyalet/Yerleşke, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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AYŞEGÜL KILIÇLI, Dr.

Role: primary

(0414) 317 17 17

Other Identifiers

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MEDITATION AND PREECLAMPSİA

Identifier Type: -

Identifier Source: org_study_id

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