AnxietyNCT05447000
The Effect of Mindfulness-Based Practices and Deep Relaxation Exercises in Pregnant Women
A study testing Mindfullness Based Stress Reduction (MBSR) intervention and Deep Relaxation Exercises intervention in people with Anxiety and Pregnancy Related, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
Pregnancy is a transitional period during which important physical, biological and psychological changes are experienced for women, and the probability of encountering factors that may cause stress, anxiety and low quality of life is high. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women only
- Conditions the study is for
- Anxiety, Pregnancy Related
- What is being tested?
- Mindfullness Based Stress Reduction (MBSR) intervention and Deep Relaxation Exercises intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 24 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- Having internet access,
- Without any diagnosed psychiatric health problem,
- At 12-24 weeks of gestation,
- There is no risk factor in pregnancy,
- Literate,
- Using smart phone,
- Having a headset accessory for phone calls,
- Pregnant women who voluntarily agreed to participate in the study
Who cannot join
- -Mental disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness-Based Practices and Deep Relaxation Exercises on Pregnancy-Related Anxiety Level
Pregnancy is a transitional period during which important physical, biological and psychological changes are experienced for women, and the probability of encountering factors that may cause stress, anxiety and low quality of life is high. Maternal stress in pregnancy is associated with negative birth outcomes and can be reduced with relaxation exercises. However, mindfulness-based approaches affect pregnancy outcomes positively. Data collected with the "Personal Description Form", and "The Pregnancy-related Anxiety Questionnaire-Revised 2".
Read the detailed description
Pregnancy is a transitional period during which important physical, biological and psychological changes are experienced for women, and the probability of encountering factors that may cause stress, anxiety and low quality of life is high. Maternal stress in pregnancy is associated with negative birth outcomes and can be reduced with relaxation exercises. However, mindfulness-based approaches affect pregnancy outcomes positively. The aim of this study, which was conducted to determine the effects of mindfulness practices and deep relaxation exercises on the level of pregnancy-related anxiety, is to create intervention programs compatible with the prenatal period and to contribute to the improvement of pregnancy outcomes. First of all, a total of 111 pregnant women (37 mindfulness based stress reduction program, 37 deep relaxation exercises and 37 control) are planned to be included in the study. However, we recalculated the power analysis with a reference study after obtaining approval and before starting the study. With the calculation we made with the reference study, we determined our final sample number as 102 pregnant women (34 individuals for the mindfulness meditation group, 34 individuals for the deep relaxation exercises group, and 34 individuals for the control group). Data collected with the "Personal Description Form", and "The Pregnancy-related Anxiety Questionnaire-Revised 2". Mindfulness and deep relaxation practices was applied by midwives who are experts in their fields who are certified in these fields.
- Conditions
- Anxiety, Pregnancy Related
- Being tested
- Mindfullness Based Stress Reduction (MBSR) intervention, Deep Relaxation Exercises intervention, No Intervention
- 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 anxiety levels with mindfulness program
Deep Relaxation Exercises interventionBehavioural
Deep Relaxation Exercises intervention: Monitoring anxiety levels with deep Relaxation Exercises intervention
No InterventionOther
No Intervention
| 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 |
| Deep Relaxation Exercises | Experimental | Deep Relaxation Exercises therapy Receives: Behavioral: Deep Relaxation Exercises intervention |
| Control | Other | Control Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Aug 2022
- Primary completion15 Oct 2022
- Study completion24 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
- 95 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
- NCT05447000
- Sponsor's protocol ID
- Amasya University
- Status last verified
- Feb 2023
- First submitted
- 1 Jul 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gokbulut N, Cengizhan SO, Akca EI, Ceran E. The effects of a mindfulness-based stress reduction program and deep relaxation exercises on pregnancy-related anxiety levels: A randomized controlled trial. Int J Nurs Pract. 2024 Oct;30(5):e13238. doi: 10.1111/ijn.13238. Epub 2024 Jan 26.
PubMed 38279199
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Practices and Deep Relaxation Exercises on Pregnancy-Related Anxiety Level
- ClinicalTrials.gov ID
- NCT05447000
- Acronym / sponsor ID
- Amasya University
- Conditions
- Anxiety, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 24 Nov 2022 (actual)
- First posted
- 7 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 transitional period during which important physical, biological and psychological changes are experienced for women, and the probability of encountering factors that may cause stress, anxiety and low quality of life is high. Maternal stress in pregnancy is associated with negative birth outcomes and can be reduced with relaxation exercises. However, mindfulness-based approaches affect pregnancy outcomes positively. Data collected with the "Personal Description Form", and "The Pregnancy-related Anxiety Questionnaire-Revised 2".
Detailed description
Pregnancy is a transitional period during which important physical, biological and psychological changes are experienced for women, and the probability of encountering factors that may cause stress, anxiety and low quality of life is high. Maternal stress in pregnancy is associated with negative birth outcomes and can be reduced with relaxation exercises. However, mindfulness-based approaches affect pregnancy outcomes positively. The aim of this study, which was conducted to determine the effects of mindfulness practices and deep relaxation exercises on the level of pregnancy-related anxiety, is to create intervention programs compatible with the prenatal period and to contribute to the improvement of pregnancy outcomes. First of all, a total of 111 pregnant women (37 mindfulness based stress reduction program, 37 deep relaxation exercises and 37 control) are planned to be included in the study. However, we recalculated the power analysis with a reference study after obtaining approval and before starting the study. With the calculation we made with the reference study, we determined our final sample number as 102 pregnant women (34 individuals for the mindfulness meditation group, 34 individuals for the deep relaxation exercises group, and 34 individuals for the control group). Data collected with the "Personal Description Form", and "The Pregnancy-related Anxiety Questionnaire-Revised 2". Mindfulness and deep relaxation practices was applied by midwives who are experts in their fields who are certified in these fields.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfullness Based Stress Reduction | Experimental | Behavioral: Mindfullness Based Stress Reduction (MBSR) interventionMindfullness Based Stress Reduction (MBSR) therapy |
| Deep Relaxation Exercises | Experimental | Behavioral: Deep Relaxation Exercises interventionDeep Relaxation Exercises therapy |
| Control | Other | Other: No InterventionControl |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Having internet access,
- Without any diagnosed psychiatric health problem,
- At 12-24 weeks of gestation,
- There is no risk factor in pregnancy,
- Literate,
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 anxiety levels with mindfulness program | Behavioural | Mindfullness Based Stress Reduction |
| Deep Relaxation Exercises interventionDeep Relaxation Exercises intervention: Monitoring anxiety levels with deep Relaxation Exercises intervention | Behavioural | Deep Relaxation Exercises |
| No InterventionNo Intervention | Other | Control |
Primary outcome
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.
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 2 Mar 2023.
- Derived from this study: PubMed 38279199Gokbulut N, Cengizhan SO, Akca EI, Ceran E. The effects of a mindfulness-based stress reduction program and deep relaxation exercises on pregnancy-related anxiety levels: A randomized controlled trial. Int J Nurs Pract. 2024 Oct;30(5):e13238. doi: 10.1111/ijn.13238. Epub 2024 Jan 26.
- 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 and Deep Relaxation Exercises 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 8 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 2 Mar 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?
Pregnancy-Related Anxiety Scale (time frame: At the end of the 1 months). 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 NCT05447000, 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 2 Mar 2023.