StressNCT05317065
The Effect of Mindfulness-Based Stress Reduction Program (MBSR) in Risky Pregnants
A study testing Mindfullness Based Stress Reduction (MBSR) intervention in people with Stress and Pregnancy, High Risk, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
Risky pregnant women need various physical and mental health needs, they need to be informed and supported by health personnel. Mindfulness is a non-judgmental and accepting focus of one's attention on what is happening right now. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women only
- Conditions the study is for
- Stress, Pregnancy, High Risk
- What is being tested?
- Mindfullness Based Stress Reduction (MBSR) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 31 Aug 2022
- 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 15 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- risky pregnant women
Who cannot join
- mental disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness-Based Stress Reduction Program (MBSR) on Stress, Anxiety and Prenatal Attachment in Risky Pregnants
Risky pregnant women need various physical and mental health needs, they need to be informed and supported by health personnel. Mindfulness is a non-judgmental and accepting focus of one's attention on what is happening right now. A total of 100 pregnant women (50 experimental, 50 control) are planned to be included in the study. Data will be collected with "Descriptive Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Pregnancy-Related Anxiety Scale-Revision 2" and "Prenatal Attachment Inventory". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the experimental group.
Read the detailed description
Risky pregnancies are a situation that can negatively affect the health of the mother and the fetus, result in the loss of the baby, and bring about physical, social and mental changes. Mindfulness-based approaches have been used in solving both physical and mental problems in pregnant women and very positive results have been obtained. The aim of this study, which was carried out to determine the effect of mindfulness-based stress reduction program (MBSR) on stress, anxiety and prenatal attachment in high-risk pregnant women, is aimed at creating appropriate intervention programs for high-risk pregnancies and contributing to the improvement of pregnancy outcomes. A total of 100 pregnant women (50 experimental, 50 control) are planned to be included in the study. Data will be collected with "Descriptive Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Pregnancy-Related Anxiety Scale-Revision 2" and "Prenatal Attachment Inventory". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the experimental group.
- Conditions
- Stress, Pregnancy, High Risk
- Being tested
- Mindfullness Based Stress Reduction (MBSR) intervention
- Keywords
- prenatal attachment, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfullness Based Stress Reduction (MBSR) interventionBehavioural
Mindfullness Based Stress Reduction (MBSR) intervention: Monitoring stress and anxiety levels with mindfulness program
| Study group | Role | What they receive |
|---|---|---|
| Mindfullness Based Stress Reduction | Experimental | Mindfullness Based Stress Reduction (MBSR) therapy Receives: Behavioral: Mindfullness Based Stress Reduction (MBSR) intervention |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal Distress Scale
The minimum score that can be obtained from the scale is "0", the maximum score is "34", and as the score obtained from the scale increases, prenatal distress levels also increase.
Measured: At the end of the 1 months
Pregnancy-Related Anxiety Scale
For primiparas, a minimum of 11 points and a maximum of 55 points is obtained, and for multipars, a minimum of 10 and a maximum of 50 points are obtained. As the score obtained from the scale increases, it is accepted that the level of anxiety in pregnancy is higher.
Measured: At the end of the 1 months
Secondary outcomes (1)
The Prenatal Attachment Inventory
A minimum of 21 and a maximum of 84 points can be obtained from the scale. The increase in the score obtained by the pregnant indicates that the level of attachment also increases.
Measured: At the end of the 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Jun 2022
- Primary completion30 Jul 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Akca, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317065
- Sponsor's protocol ID
- Amasya Univesity
- Status last verified
- Feb 2023
- First submitted
- 30 Mar 2022
- Last updated
- 24 Feb 2023
- 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 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Stress Reduction Program (MBSR) on Stress, Anxiety and Prenatal Attachment in Risky Pregnants
- ClinicalTrials.gov ID
- NCT05317065
- Acronym / sponsor ID
- Amasya Univesity
- Conditions
- Stress, Pregnancy, High Risk
- Keywords
- prenatal attachment, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 7 Apr 2022 (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.
Risky pregnant women need various physical and mental health needs, they need to be informed and supported by health personnel. Mindfulness is a non-judgmental and accepting focus of one's attention on what is happening right now. A total of 100 pregnant women (50 experimental, 50 control) are planned to be included in the study. Data will be collected with "Descriptive Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Pregnancy-Related Anxiety Scale-Revision 2" and "Prenatal Attachment Inventory". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the experimental group.
Detailed description
Risky pregnancies are a situation that can negatively affect the health of the mother and the fetus, result in the loss of the baby, and bring about physical, social and mental changes. Mindfulness-based approaches have been used in solving both physical and mental problems in pregnant women and very positive results have been obtained. The aim of this study, which was carried out to determine the effect of mindfulness-based stress reduction program (MBSR) on stress, anxiety and prenatal attachment in high-risk pregnant women, is aimed at creating appropriate intervention programs for high-risk pregnancies and contributing to the improvement of pregnancy outcomes. A total of 100 pregnant women (50 experimental, 50 control) are planned to be included in the study. Data will be collected with "Descriptive Information Form", "Prenatal Distress Scale (PBL)-Revised Version", "Pregnancy-Related Anxiety Scale-Revision 2" and "Prenatal Attachment Inventory". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the experimental group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfullness Based Stress Reduction | Experimental | Behavioral: Mindfullness Based Stress Reduction (MBSR) interventionMindfullness Based Stress Reduction (MBSR) therapy |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- risky pregnant women
Key exclusion criteria (1 listed)
- mental disabilities
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 |
|---|---|---|
| Mindfullness Based Stress Reduction (MBSR) interventionMindfullness Based Stress Reduction (MBSR) intervention: Monitoring stress and anxiety levels with mindfulness program | Behavioural | Mindfullness Based Stress Reduction |
Primary outcome
Prenatal Distress Scale
Time frame: At the end of the 1 months
The minimum score that can be obtained from the scale is "0", the maximum score is "34", and as the score obtained from the scale increases, prenatal distress levels also increase.
Pregnancy-Related Anxiety Scale
Time frame: At the end of the 1 months
For primiparas, a minimum of 11 points and a maximum of 55 points is obtained, and for multipars, a minimum of 10 and a maximum of 50 points are obtained. As the score obtained from the scale increases, it is accepted that the level of anxiety in pregnancy is higher.
1 secondary outcome
The Prenatal Attachment Inventory
Time frame: At the end of the 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfullness Based Stress Reduction (MBSR) intervention in people with Stress and Pregnancy, High Risk, run by Amasya University 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 1 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: finished, as of the sponsor's last update on 24 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prenatal Distress Scale (time frame: At the end of the 1 months). The study lists 2 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 24 Feb 2023.