Gestational Diabetes Mellitus (GDM)NCT06960109
Effect of the Mindfulness-Based Stress Reduction Program on Prenatal Attachment, Distress and Anxiety Levels in Pregnant Women With Gestational Diabetes
A study testing A Mindfulness-Based Stress Reduction Program for Pregnant Women with Gestational Diabetes in people with Gestational Diabetes Mellitus (GDM) and Mindfulness, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to evaluate the potential effects of a mindfulness-based stress reduction (MBSR) program on prenatal attachment, distress, and anxiety levels among pregnant women diagnosed with gestational diabetes mellitus (GDM). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM), Mindfulness, Prenatal Attachment
- What is being tested?
- A Mindfulness-Based Stress Reduction Program for Pregnant Women with Gestational Diabetes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Oct 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those diagnosed with Gestational Diabetes Mellitus,
- Those whose pregnancy is between 24-34 weeks,
- Those who can read and write in Turkish, and those who do not have hearing or speech problems,
- Pregnant women who volunteered to participate in the study.
Who cannot join
- Those who could not complete the Mindfulness-Based Stress Reduction Program,
- Pregnant women who gave birth while the study was ongoing.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik Şehir Kadın Doğum Hastanesi
Ankara, 06010
About this study
This randomized controlled study aims to evaluate the potential effects of a mindfulness-based stress reduction (MBSR) program on prenatal attachment, distress, and anxiety levels among pregnant women diagnosed with gestational diabetes mellitus (GDM). The study was conducted at Ankara Etlik City Hospital between October 2023 and 2024, and included 50 pregnant women with GDM, randomly assigned to an intervention group (n=25) or a control group (n=25). The MBSR program was implemented online for the intervention group, delivered in 8 sessions over 4 weeks.
Read the detailed description
DATA COLLECTION Data were collected by the principal investigator from pregnant women who applied to the Perinatology Clinic and met the inclusion criteria. The study adhered to the principles of the Declaration of Helsinki. Written informed consent was obtained from each participant. After the purpose and importance of the study were explained to eligible and voluntarily participating individuals, pre-test questionnaire forms were administered face-to-face. The forms were completed using the self-report method. In shared rooms, participants were directed to a quiet room to ensure privacy. Any questions raised by the participants were answered before and during the data collection process. Completion of the forms took approximately 10-15 minutes per participant.
To collect post-test data, an online survey was created using Google Forms. The link was distributed via WhatsApp groups established in the fourth week after the training. Participants in these groups completed the forms using the shared link.
MINDFULNESS-BASED STRESS REDUCTION PROGRAM FOR PREGNANT WOMEN WITH GESTATIONAL DIABETES MELLITUS
Preliminary Preparation Prior to initiating the intervention, the principal investigator attended an eight-week Mindfulness-Based Stress Reduction (MBSR) Program organized by the Mindfulness Institute (14.02.2023-04.04.2023), led by Prof. Dr. Zümra Atalay.
Preparation of Training Content The training content of the MBSR program tailored for pregnant women with gestational diabetes was developed based on a literature review and the training received. Expert opinions were obtained from three professionals in obstetrics, gynecology, and midwifery to assess the content's relevance and applicability. Revisions were made according to their feedback, and the finalized version was completed.
Implementation of the Program Participants in the intervention group who completed the pre-test and agreed to join the program were included in WhatsApp groups created by the principal investigator. Three separate groups were formed, each comprising a maximum of 11 participants. Group-specific training schedules (e.g., Group 1: Tuesdays and Saturdays) were arranged according to participant availability. The MBSR program was conducted over four weeks, consisting of eight sessions (two sessions per week), each lasting approximately 45-60 minutes.
Sessions were conducted via Google Meet. The training incorporated PowerPoint presentations, verbal instruction, Q\&A, and mindfulness exercises (e.g., raisin exercise, mindful breathing, sitting meditation, sound and thought meditation). Homework assignments (e.g., mindful eating, mindful showering, breathing exercises, compassion meditation) were given at the end of each session, and audio recordings of the meditations were provided for practice. In each subsequent session, participants received verbal feedback on their homework.
- Being tested
- A Mindfulness-Based Stress Reduction Program for Pregnant Women with Gestational Diabetes
- Keywords
- Gestational Diabetes Mellitus, Mindfulness, Prenatal attachment, Prenatal Distress, Anxiety, Midwifery
- Medical subject headings
- Diabetes, Gestational, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Mindfulness-Based Stress Reduction Program for Pregnant Women with Gestational DiabetesBehavioural
The Gestational diabetes mellitus(GDM) pregnant women in the intervention group who agreed to participate in the study and completed the pre-test were invited to the WhatsApp group created by the researcher. 3 separate groups were created with a maximum of 11 participants in each group. The days (for example; Group 1: Tuesday, Saturday) on which the program, which will continue for 4 weeks, will be implemented were determined, considering the participants in each group and the times they were available. For each group, the conscious awareness-based stress reduction program for pregnant women with GDM; For 4 weeks, there were 8 sessions, 2 sessions per week, with each session varying in duration, for an average of 45-60 minutes. The program was carried out using the Google Meet application created online by the researcher, and the connection details were shared with the participants via WhatsApp groups. In the implementation of the mindfulness-based stress reduction program for pregnant
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: Mindfulness-Based Stress Reduction Program | Active comparator | A Mindfulness-Based Stress Reduction Program for Pregnant Women with Gestational Diabetes was applied to 25 pregnant women with gestational diabetes in the intervention group, 2 sessions per week for 4 weeks, for a total of 8 sessions. Receives: Behavioral: A Mindfulness-Based Stress Reduction Program for Pregnant Women with Gestational Diabetes |
| Routine Care (Control Group) | No intervention | 25 pregnant women with gestational diabetes in the control group received only routine prenatal care without any additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prenatal Attachment Inventory (PAI) scores
To evaluate the effect of the Mindfulness-Based Stress Reduction Program on prenatal attachment levels in pregnant women with gestational diabetes.
The four-point Likert-type scale, with each item scored between 1 and 4, consists of a total of 21 items. Participants were asked to select the option most appropriate for them in the inventory as Never (1), Sometimes (2), Often (3), Always (4). The total score that can be obtained from the scale is a minimum of 21 and a maximum of 84 points.
Measured: From pre-test (baseline) to 4 weeks post-intervention
Change in Prenatal Distress Questionnaire (NuPDQ) scores
To evaluate the effect of the Mindfulness-Based Stress Reduction Program on prenatal distress levels in pregnant women with gestational diabetes.
Participants are asked to mark one of the options listed as Not at all (0), A little (1) and A lot (2) that best suits them regarding whether they are distressed, sad or anxious. The distress score experienced during pregnancy is obtained by adding the scale item scores. The lowest score obtained from the scale is 0, the highest score is 34. As the total score obtained from the scale increases, the level of prenatal distress perceived by pregnant women also increases. The scale has 4 sub-dimensions. They are divided into physical and social changes related to pregnancy, concerns about the baby and birth (Items 1-3-4-6-7-8-10-11-12), concerns about the quality of health care and health status (Items 2-9-17), concerns about the baby's care and life after birth (Items 13-15-16), and financial concerns (Items 5-14).
Measured: From pre-test (baseline) to 4 weeks post-intervention
Change in State-Trait Anxiety Inventory (STAI-S-T) scores
To evaluate the effect of the Mindfulness-Based Stress Reduction Program on state anxiety levels in pregnant women with gestational diabetes.
STAI-S consists of 20 items; STAI-T, which answers general feelings, consists of 40 items. Both scales are four-point Likert type, and in STAI-S, it is requested to mark the most appropriate option from the options listed as Never (1), A Little (2), A Lot (3), Completely (4), in STAI- Almost Never (1), Sometimes (2), A Lot of Time (3), Almost Always (4). STAI scale shows negative feelings as direct expressions, and positive feelings as reverse expressions. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 in STAI-S Scale and items 26, 27, 30, 33, 36 and 39 in STAI-T Scale are reversed. Direct expressions indicate negative feelings in the individual, and reverse expressions indicate positive feelings in the individual. Scores from both scales vary between 20 and 80.
Measured: From pre-test (baseline) to 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Oct 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies 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
- Model description
- In a randomized controlled trial, pregnant women with gestational diabetes were divided into two groups: 25 intervention groups and 25 controls. The intervention group received the Mindfulness-Based Stress Reduction Program for Pregnant Women with Gestational Diabetes for 4 weeks.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960109
- Sponsor's protocol ID
- AEŞH-EK1-2023-267
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 7 May 2025
- 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 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Mindfulness-Based Stress Reduction Program on Prenatal Attachment, Distress and Anxiety Levels in Pregnant Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT06960109
- Acronym / sponsor ID
- AEŞH-EK1-2023-267
- Keywords
- Gestational Diabetes Mellitus, Mindfulness, Prenatal attachment, Prenatal Distress, Anxiety, Midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 7 May 2025 (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.
This randomized controlled study aims to evaluate the potential effects of a mindfulness-based stress reduction (MBSR) program on prenatal attachment, distress, and anxiety levels among pregnant women diagnosed with gestational diabetes mellitus (GDM). The study was conducted at Ankara Etlik City Hospital between October 2023 and 2024, and included 50 pregnant women with GDM, randomly assigned to an intervention group (n=25) or a control group (n=25). The MBSR program was implemented online for the intervention group, delivered in 8 sessions over 4 weeks.
Detailed description
DATA COLLECTION Data were collected by the principal investigator from pregnant women who applied to the Perinatology Clinic and met the inclusion criteria. The study adhered to the principles of the Declaration of Helsinki. Written informed consent was obtained from each participant. After the purpose and importance of the study were explained to eligible and voluntarily participating individuals, pre-test questionnaire forms were administered face-to-face. The forms were completed using the self-report method. In shared rooms, participants were directed to a quiet room to ensure privacy. Any questions raised by the participants were answered before and during the data collection process. Completion of the forms took approximately 10-15 minutes per participant.
To collect post-test data, an online survey was created using Google Forms. The link was distributed via WhatsApp groups established in the fourth week after the training. Participants in these groups completed the forms using the shared link.
MINDFULNESS-BASED STRESS REDUCTION PROGRAM FOR PREGNANT WOMEN WITH GESTATIONAL DIABETES MELLITUS
Preliminary Preparation Prior to initiating the intervention, the principal investigator attended an eight-week Mindfulness-Based Stress Reduction (MBSR) Program organized by the Mindfulness Institute (14.02.2023-04.04.2023), led by Prof. Dr. Zümra Atalay.
Preparation of Training Content The training content of the MBSR program tailored for pregnant women with gestational diabetes was developed based on a literature review and the training received. Expert opinions were obtained from three professionals in obstetrics, gynecology, and midwifery to assess the content's relevance and applicability. Revisions were made according to their feedback, and the finalized version was completed.
Implementation of the Program Participants in the intervention group who completed the pre-test and agreed to join the program were included in WhatsApp groups created by the principal investigator. Three separate groups were formed, each comprising a maximum of 11 participants. Group-specific training schedules (e.g., Group 1: Tuesdays and Saturdays) were arranged according to participant availability. The MBSR program was conducted over four weeks, consisting of eight sessions (two sessions per week), each lasting approximately 45-60 minutes.
Sessions were conducted via Google Meet. The training incorporated PowerPoint presentations, verbal instruction, Q\&A, and mindfulness exercises (e.g., raisin exercise, mindful breathing, sitting meditation, sound and thought meditation). Homework assignments (e.g., mindful eating, mindful showering, breathing exercises, compassion meditation) were given at the end of each session, and audio recordings of the meditations were provided for practice. In each subsequent session, participants received verbal feedback on their homework.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In a randomized controlled trial, pregnant women with gestational diabetes were divided into two groups: 25 intervention groups and 25 controls. The intervention group received the Mindfulness-Based Stress Reduction Program for Pregnant Women with Gestational Diabetes for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Mindfulness-Based Stress Reduction Program | Active comparator | Behavioral: A Mindfulness-Based Stress Reduction Program for Pregnant Women with Gestational DiabetesA Mindfulness-Based Stress Reduction Program for Pregnant Women with Gestational Diabetes was applied to 25 pregnant women with gestational diabetes in the intervention group, 2 sessions per week for 4 weeks, for a total of 8 sessions. |
| Routine Care (Control Group) | No intervention | –25 pregnant women with gestational diabetes in the control group received only routine prenatal care without any additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those diagnosed with Gestational Diabetes Mellitus,
- Those whose pregnancy is between 24-34 weeks,
- Those who can read and write in Turkish, and those who do not have hearing or speech problems,
- Pregnant women who volunteered to participate in the study.
Key exclusion criteria (2 listed)
- Those who could not complete the Mindfulness-Based Stress Reduction Program,
- Pregnant women who gave birth while the study was ongoing.
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 |
|---|---|---|
| A Mindfulness-Based Stress Reduction Program for Pregnant Women with Gestational DiabetesThe Gestational diabetes mellitus(GDM) pregnant women in the intervention group who agreed to participate in the study and completed the pre-test were invited to the WhatsApp group created by the researcher. 3 separate groups were created with a maximum of 11 participants in each group. The days (for example; Group 1: Tuesday, Saturday) on which the program, which will continue for 4 weeks, will be implemented were determined, considering the participants in each group and the times they were available. For each group, the conscious awareness-based stress reduction program for pregnant women with GDM; For 4 weeks, there were 8 sessions, 2 sessions per week, with each session varying in duration, for an average of 45-60 minutes. The program was carried out using the Google Meet application created online by the researcher, and the connection details were shared with the participants via WhatsApp groups. In the implementation of the mindfulness-based stress reduction program for pregnant | Behavioural | Intervention group: Mindfulness-Based Stress Reduction Program |
Primary outcome
Change in Prenatal Attachment Inventory (PAI) scores
Time frame: From pre-test (baseline) to 4 weeks post-intervention
To evaluate the effect of the Mindfulness-Based Stress Reduction Program on prenatal attachment levels in pregnant women with gestational diabetes. The four-point Likert-type scale, with each item scored between 1 and 4, consists of a total of 21 items. Participants were asked to select the option most appropriate for them in the inventory as Never (1), Sometimes (2), Often (3), Always (4). The total score that can be obtained from the scale is a minimum of 21 and a maximum of 84 points.
Change in Prenatal Distress Questionnaire (NuPDQ) scores
Time frame: From pre-test (baseline) to 4 weeks post-intervention
To evaluate the effect of the Mindfulness-Based Stress Reduction Program on prenatal distress levels in pregnant women with gestational diabetes. Participants are asked to mark one of the options listed as Not at all (0), A little (1) and A lot (2) that best suits them regarding whether they are distressed, sad or anxious. The distress score experienced during pregnancy is obtained by adding the scale item scores. The lowest score obtained from the scale is 0, the highest score is 34. As the total score obtained from the scale increases, the level of prenatal distress perceived by pregnant women also increases. The scale has 4 sub-dimensions. They are divided into physical and social changes related to pregnancy, concerns about the baby and birth (Items 1-3-4-6-7-8-10-11-12), concerns about the quality of health care and health status (Items 2-9-17), concerns about the baby's care and life after birth (Items 13-15-16), and financial concerns (Items 5-14).
Change in State-Trait Anxiety Inventory (STAI-S-T) scores
Time frame: From pre-test (baseline) to 4 weeks post-intervention
To evaluate the effect of the Mindfulness-Based Stress Reduction Program on state anxiety levels in pregnant women with gestational diabetes. STAI-S consists of 20 items; STAI-T, which answers general feelings, consists of 40 items. Both scales are four-point Likert type, and in STAI-S, it is requested to mark the most appropriate option from the options listed as Never (1), A Little (2), A Lot (3), Completely (4), in STAI- Almost Never (1), Sometimes (2), A Lot of Time (3), Almost Always (4). STAI scale shows negative feelings as direct expressions, and positive feelings as reverse expressions. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 in STAI-S Scale and items 26, 27, 30, 33, 36 and 39 in STAI-T Scale are reversed. Direct expressions indicate negative feelings in the individual, and reverse expressions indicate positive feelings in the individual. Scores from both scales vary between 20 and 80.
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 7 May 2025.
- 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 A Mindfulness-Based Stress Reduction Program for Pregnant Women with Gestational Diabetes in people with Gestational Diabetes Mellitus (GDM) and Mindfulness, run by Saglik Bilimleri Universitesi 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 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 7 May 2025. 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?
Change in Prenatal Attachment Inventory (PAI) scores (time frame: From pre-test (baseline) to 4 weeks post-intervention). The study lists 3 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 7 May 2025.