AnxietyNCT05441124
The Effect of Web-based Mindfulness-based Stress Reduction Program on Pregnant Women
A study testing Mindfullness Based Stress Reduction (MBSR) intervention in people with Anxiety and Pregnancy Related, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
Pregnancy is a period in which physiological and psychological changes are experienced and discomforts related to these changes are observed, and comfort is affected for the pregnant. However, fetal health concern refers to the concern of the expectant mother about the health of her developing fetus. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Pregnancy Related
- 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
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 Nov 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Not having any diagnosed psychiatric disease,
- Literate,
- Using a smart phone,
- With internet access
- Having a headset accessory for phone calls,
- Pregnant women who voluntarily agreed to participate in the study
Who cannot join
- Filling in the questionnaire form incompletely,
- Pregnant women with communication barriers and mental disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Web-based Mindfulness-Based Stress Reduction Program on Prenatal Comfort and Fetal Anxiety Levels in Pregnants
Pregnancy is a period in which physiological and psychological changes are experienced and discomforts related to these changes are observed, and comfort is affected for the pregnant. However, fetal health concern refers to the concern of the expectant mother about the health of her developing fetus. Mindfulness is a non-judgmental and accepting focus of one's attention on what is happening right now. A total of 96 pregnant women (48 experimental, 48 control) are planned to be included in the study. Data will be collected with the "Personal Description Form", "Prenatal Comfort Scale (PCS)" and "Fetal Health Anxiety Inventory (FHAI)". 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
Women experience intense physiological, psychological and social changes during pregnancy and postpartum period. Pregnancy and postpartum period can be a difficult process for some women due to biological and environmental factors. 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 is carried out to determine the effect of mindfulness on prenatal comfort and fetal anxiety levels in pregnant women, is aimed at creating intervention programs compatible with the antenatal period and contributing to the improvement of pregnancy outcomes. A total of 96 pregnant women (48 experimental, 48 control) are planned to be included in the study. Data will be collected with the "Personal Description Form", "Prenatal Comfort Scale (PCS)" and "Fetal Health Anxiety Inventory (FHAI)". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the
- Conditions
- Anxiety, Pregnancy Related
- Being tested
- Mindfullness Based Stress Reduction (MBSR) intervention
- Keywords
- Prenatal Comfort, MBSR
- 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 Comfort Scale
The minimum score that can be obtained from the scale is "0", the maximum score is "75", and as the score obtained from the scale increases, prenatal comfort levels also increase.
Measured: At the end of the 2 months
Fetal Health Anxiety Inventory
The minimum score that can be obtained from the scale is "0", the maximum score is "42", and as the score obtained from the scale increases, fetal health anxiety levels also increase.
Measured: At the end of the 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Jul 2022
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- 89 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
- NCT05441124
- Sponsor's protocol ID
- Amasya Uni
- Status last verified
- Feb 2023
- First submitted
- 28 Jun 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
Publications
Ibici Akca E, Gokbulut N, Cengizhan SO. The Effects of MBSR Programme on Prenatal Comfort and Fetal Health Anxiety in Pregnant Women. J Reprod Infant Psychol. 2024 Jun;42(3):449-463. doi: 10.1080/02646838.2023.2227219. Epub 2023 Jun 21.
PubMed 37342975
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 Web-based Mindfulness-Based Stress Reduction Program on Prenatal Comfort and Fetal Anxiety Levels in Pregnants
- ClinicalTrials.gov ID
- NCT05441124
- Acronym / sponsor ID
- Amasya Uni
- Conditions
- Anxiety, Pregnancy Related
- Keywords
- Prenatal Comfort, MBSR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 1 Jul 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.
Pregnancy is a period in which physiological and psychological changes are experienced and discomforts related to these changes are observed, and comfort is affected for the pregnant. However, fetal health concern refers to the concern of the expectant mother about the health of her developing fetus. Mindfulness is a non-judgmental and accepting focus of one's attention on what is happening right now. A total of 96 pregnant women (48 experimental, 48 control) are planned to be included in the study. Data will be collected with the "Personal Description Form", "Prenatal Comfort Scale (PCS)" and "Fetal Health Anxiety Inventory (FHAI)". 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
Women experience intense physiological, psychological and social changes during pregnancy and postpartum period. Pregnancy and postpartum period can be a difficult process for some women due to biological and environmental factors. 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 is carried out to determine the effect of mindfulness on prenatal comfort and fetal anxiety levels in pregnant women, is aimed at creating intervention programs compatible with the antenatal period and contributing to the improvement of pregnancy outcomes. A total of 96 pregnant women (48 experimental, 48 control) are planned to be included in the study. Data will be collected with the "Personal Description Form", "Prenatal Comfort Scale (PCS)" and "Fetal Health Anxiety Inventory (FHAI)". In the study, a stress reduction program (MBSR) based on mindfulness will be applied by the researcher to the pregnant women in the
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
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Not having any diagnosed psychiatric disease,
- Literate,
- Using a smart phone,
- With internet access
- Having a headset accessory for phone calls,
Key exclusion criteria (2 listed)
- Filling in the questionnaire form incompletely,
- Pregnant women with communication barriers and 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 Comfort Scale
Time frame: At the end of the 2 months
The minimum score that can be obtained from the scale is "0", the maximum score is "75", and as the score obtained from the scale increases, prenatal comfort levels also increase.
Fetal Health Anxiety Inventory
Time frame: At the end of the 2 months
The minimum score that can be obtained from the scale is "0", the maximum score is "42", and as the score obtained from the scale increases, fetal health anxiety levels also increase.
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.
- Derived from this study: PubMed 37342975Ibici Akca E, Gokbulut N, Cengizhan SO. The Effects of MBSR Programme on Prenatal Comfort and Fetal Health Anxiety in Pregnant Women. J Reprod Infant Psychol. 2024 Jun;42(3):449-463. doi: 10.1080/02646838.2023.2227219. Epub 2023 Jun 21.
- 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 Anxiety and Pregnancy Related, 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 6 inclusion and 2 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 Comfort Scale (time frame: At the end of the 2 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?
On the ClinicalTrials.gov record for NCT05441124, which also lists 1 linked publication.
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.