Mindfulness Breath Awareness MeditationNCT06065709
Mindfulness Breath Awareness Meditation and Preeclampsia
A study testing Mindfulness breath awareness meditation in people with Mindfulness Breath Awareness Meditation and Preeclampsia, run by Aysegul Kilicli at 1 site in Turkey (Türkiye).
Trial summary
The effect of mindfulness breath awareness meditation on health profile, vital signs, and fetal heart rate in pregnant women with preeclampsia Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mindfulness Breath Awareness Meditation, Preeclampsia
- What is being tested?
- Mindfulness breath awareness meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Pregnant women who do not meet the inclusion criteria and who voluntarily withdraw at any stage after inclusion will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Şanlıurfa training and research hospital
Sanliurfa, Eyalet/Yerleşke, 63000
AYŞEGÜL KILIÇLI, Dr., (0414) 317 17 17, aysegul_ay_9@hotmail.com
About this study
Official title: 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
Read the 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.
- Being tested
- Mindfulness breath awareness meditation
- Keywords
- Mindfulness breath awareness meditation, Preeclampsia, Pregnant women, Health profile, Vital signs, Fetal heart rate
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness breath awareness meditationBehavioural
Mindfulness breath awareness meditation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness breath awareness meditation |
| control group | No intervention | only mindfulness breath awareness meditation will not be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Body temperature
Body temperature
Measured: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Pulse
Pulse
Measured: 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
Measured: 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
Measured: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Respiratory rate
Respiratory rate
Measured: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Oxygen saturation
Oxygen saturation
Measured: 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
fetal movement count
Measured: 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
Measured: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Oct 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mindfulness Breath Awareness MeditationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aysegul Kilicli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aysegul Kilicli, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065709
- Sponsor's protocol ID
- MEDITATION AND PREECLAMPSİA
- Status last verified
- Mar 2024
- First submitted
- 19 Sep 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Breath Awareness Meditation on Health Profile, Vital Signs, and Fetal Heart Rate in Pregnant Women Diagnosed With Preeclampsia
- ClinicalTrials.gov ID
- NCT06065709
- Acronym / sponsor ID
- MEDITATION AND PREECLAMPSİA
- Keywords
- Mindfulness breath awareness meditation, Preeclampsia, Pregnant women, Health profile, Vital signs, Fetal heart rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Aysegul KilicliUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of mindfulness breath awareness meditation on health profile, vital signs, and fetal heart rate in pregnant women with preeclampsia
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Mindfulness breath awareness meditation group | Experimental | Behavioral: Mindfulness breath awareness meditationMindfulness 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. |
| control group | No intervention | –only mindfulness breath awareness meditation will not be applied to the control group. |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnant women who do not meet the inclusion criteria and who voluntarily withdraw at any stage after inclusion will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness breath awareness meditationMindfulness breath awareness meditation | Behavioural | Mindfulness breath awareness meditation group |
Primary outcome
Nottingham Health Profile
Time frame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
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.
Fetal heart rate
Time frame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Fetal heart rate
Body temperature
Time frame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Body temperature
Pulse
Time frame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Pulse
Systolic blood pressure
Time frame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Systolic blood pressure
Diastolic blood pressure
Time frame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Diastolic blood pressure
Respiratory rate
Time frame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Respiratory rate
Oxygen saturation
Time frame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Oxygen saturation
2 secondary outcomes
fetal movement count
Time frame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Nottingham Health Profile subdimensions
Time frame: It will be evaluated before the first application and then every 24 hours for a total of 4 times
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şanlıurfa training and research hospital
Sanliurfa, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness breath awareness meditation in people with Mindfulness Breath Awareness Meditation and Preeclampsia, run by Aysegul Kilicli at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nottingham Health Profile (time frame: It will be evaluated before the first application and then every 24 hours for a total of 4 times). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.