Mindfulness Breath Awareness Meditation and Preeclampsia

NCT06065709 | Recruiting

• 1 other identifier: MEDITATION AND PREECLAMPSİA
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mindfulness Breath Awareness Meditation; Preeclampsia

Keywords

Mindfulness breath awareness meditation; Preeclampsia; Pregnant women; Health profile; Vital signs; Fetal heart rate

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• 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

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

Study Arms (2)

Mindfulness breath awareness meditation group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

Mindfulness breath awareness meditation BEHAVIORAL

Mindfulness breath awareness meditation

Mindfulness breath awareness meditation group

Eligibility Criteria

• Age: 19 Years - 49 Years
• Gender Eligibility Details: pregnant women diagnosed with preeclampsia
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Aysegul Kilicli: lead

Study Sites (1)

Şanlıurfa training and research hospital

Sanliurfa, Eyalet/Yerleşke, 63000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: gaziantep university health sciences enstitute nursing department PhD

Model Details: randomised controlled trial

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 4, 2023
• Study Start: October 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)