Breath Awareness Meditation and Preeclampsia

Sponsor
Aysegul Kilicli (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06065709
Collaborator
(none)
66
2
6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Breath awareness meditation
N/A

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.

Randomization:
  • The randomisation method will be done by envelope method.

  • 33 pieces of BAM, and 33 pieces of control papers will be placed in closed opaque envelopes and mixed in a bag.

  • Mothers will be asked to choose one envelope from the bag before the application.

  • The information in the envelope will not be told to the mothers. Assignment to groups will be determined in this way.

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomised controlled trialrandomised controlled trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
The Effect of Breath Awareness Meditation on Vital Signs, Health Profile, and Fetal Heart Rate in Pregnant Women Diagnosed With Preeclampsia
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Breath awareness meditation group

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.

Behavioral: Breath awareness meditation
Breath awareness meditation

No Intervention: control group

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

Outcome Measures

Primary Outcome Measures

  1. Nottingham Health Profile Scale [immediately before application]

    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.

  2. Nottingham Health Profile Scale [immediately after application]

    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.

  3. Fetal heart rate [immediately before application]

    Fetal heart rate

  4. Fetal heart rate [immediately after application]

    Fetal heart rate

  5. Body temperature [immediately before application]

    Body temperature

  6. Body temperature [immediately after application]

    Body temperature

  7. Pulse [immediately before application]

    Pulse

  8. Pulse [immediately after application]

    Pulse

  9. Systolic blood pressure [immediately before application]

    Systolic blood pressure

  10. Systolic blood pressure [immediately after application]

    Systolic blood pressure

  11. Diastolic blood pressure [immediately before application]

    Diastolic blood pressure

  12. Diastolic blood pressure [immediately after application]

    Diastolic blood pressure

  13. Respiratory rate [immediately before application]

    Respiratory rate

  14. Respiratory rate [immediately after application]

    Respiratory rate

  15. Oxygen saturation [immediately before application]

    Oxygen saturation

  16. Oxygen saturation [immediately after application]

    Oxygen saturation

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Aysegul Kilicli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aysegul Kilicli, gaziantep university health sciences enstitute nursing department PhD, University of Gaziantep
ClinicalTrials.gov Identifier:
NCT06065709
Other Study ID Numbers:
  • MEDITATION AND PREECLAMPSÄ°A
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aysegul Kilicli, gaziantep university health sciences enstitute nursing department PhD, University of Gaziantep
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2023