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Breath Awareness Meditation and Preeclampsia

Primary Purpose

Breath Awareness Meditation, Preeclampsia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Breath awareness meditation
Sponsored by
Aysegul Kilicli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breath Awareness Meditation focused on measuring Breath awareness meditation, Preeclampsia, Pregnant women, Health profile, Vital signs, Fetal heart rate

Eligibility Criteria

19 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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 were 28 and over weeks of gestation. 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.

Sites / Locations

  • Şanlıurfa training and research hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Breath awareness meditation group

control group

Arm Description

Breath awareness meditation will be performed three times in total, once every eight hours within 24 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 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.

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

Outcomes

Primary Outcome Measures

Nottingham Health Profile Scale
Nottingham Health Profile Scale; 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.
Nottingham Health Profile Scale
Nottingham Health Profile Scale; 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.
Fetal heart rate
Fetal heart rate
Fetal heart rate
Fetal heart rate
Body temperature
Body temperature
Body temperature
Body temperature
Pulse
Pulse
Pulse
Pulse
Systolic blood pressure
Systolic blood pressure
Systolic blood pressure
Systolic blood pressure
Diastolic blood pressure
Diastolic blood pressure
Diastolic blood pressure
Diastolic blood pressure
Respiratory rate
Respiratory rate
Respiratory rate
Respiratory rate
Oxygen saturation
Oxygen saturation
Oxygen saturation
Oxygen saturation

Secondary Outcome Measures

Full Information

First Posted
September 19, 2023
Last Updated
October 13, 2023
Sponsor
Aysegul Kilicli
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1. Study Identification

Unique Protocol Identification Number
NCT06065709
Brief Title
Breath Awareness Meditation and Preeclampsia
Official Title
The Effect of Breath Awareness Meditation on Vital Signs, Health Profile, and Fetal Heart Rate in Pregnant Women Diagnosed With Preeclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aysegul Kilicli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The effect of breath awareness meditation on vital signs, health profile and fetal heart rate in pregnant women with preeclampsia
Detailed Description
The aim of this study is to determine the effect of breath awareness meditation (BAM) on vital signs, health profile 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 woman diagnosed with pre-eclampsia is admitted to the Perinatology service. It will be applied three times in total, once every eight hours during the 24 hours that the pregnant woman is hospitalised in the ward. Each application session will last 30 minutes. Only breath awareness meditation (BAM) 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 breath awareness meditation practice will last 30 minutes. Pregnant women will fill the Nottingham Health Profile Scale immediately before and after each application. Vital signs and fetal heart rate will be measured immediately before and after each procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breath Awareness Meditation, Preeclampsia
Keywords
Breath awareness meditation, Preeclampsia, Pregnant women, Health profile, Vital signs, Fetal heart rate

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomised controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breath awareness meditation group
Arm Type
Experimental
Arm Description
Breath awareness meditation will be performed three times in total, once every eight hours within 24 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 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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
only breath awareness meditation will not be applied to the control group.
Intervention Type
Behavioral
Intervention Name(s)
Breath awareness meditation
Intervention Description
Breath awareness meditation
Primary Outcome Measure Information:
Title
Nottingham Health Profile Scale
Description
Nottingham Health Profile Scale; 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.
Time Frame
immediately before breath awareness meditation application
Title
Nottingham Health Profile Scale
Description
Nottingham Health Profile Scale; 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.
Time Frame
immediately after breath awareness meditation application
Title
Fetal heart rate
Description
Fetal heart rate
Time Frame
immediately before breath awareness meditation application
Title
Fetal heart rate
Description
Fetal heart rate
Time Frame
immediately after breath awareness meditation application
Title
Body temperature
Description
Body temperature
Time Frame
immediately before breath awareness meditation application
Title
Body temperature
Description
Body temperature
Time Frame
immediately after breath awareness meditation application
Title
Pulse
Description
Pulse
Time Frame
immediately before breath awareness meditation application
Title
Pulse
Description
Pulse
Time Frame
immediately after breath awareness meditation application
Title
Systolic blood pressure
Description
Systolic blood pressure
Time Frame
immediately before breath awareness meditation application
Title
Systolic blood pressure
Description
Systolic blood pressure
Time Frame
immediately after breath awareness meditation application
Title
Diastolic blood pressure
Description
Diastolic blood pressure
Time Frame
immediately before breath awareness meditation pplication
Title
Diastolic blood pressure
Description
Diastolic blood pressure
Time Frame
immediately after breath awareness meditation application
Title
Respiratory rate
Description
Respiratory rate
Time Frame
immediately before breath awareness meditation application
Title
Respiratory rate
Description
Respiratory rate
Time Frame
immediately after breath awareness meditation application
Title
Oxygen saturation
Description
Oxygen saturation
Time Frame
immediately before breath awareness meditation application
Title
Oxygen saturation
Description
Oxygen saturation
Time Frame
immediately after breath awareness meditation application

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women diagnosed with preeclampsia
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 were 28 and over weeks of gestation. 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.
Facility Information:
Facility Name
Şanlıurfa training and research hospital
City
Şanlıurfa
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
63000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AYŞEGÜL KILIÇLI, Dr.
Phone
(0414) 317 17 17
Email
aysegul_ay_9@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Breath Awareness Meditation and Preeclampsia

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