Clinical trial NCT06960109: Effect of the Mindfulness-Based Stress Reduction Program on Prenatal Attachment, Distress and Anxiety Levels in Pregnant Women With Gestational Diabetes
Official title: Effect of the Mindfulness-Based Stress Reduction Program on Prenatal Attachment, Distress and Anxiety Levels in Pregnant Women With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus (GDM)
Mindfulness
Prenatal Attachment
Distress
Anxiety
Keywords: Gestational Diabetes Mellitus
Mindfulness
Prenatal attachment
Prenatal Distress
Anxiety
Midwifery
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Those who could not complete the Mindfulness-Based Stress Reduction Program,
* Pregnant women who gave birth while the study was ongoing.

Primary outcomes:
measure: Change in Prenatal Attachment Inventory (PAI) scores
timeFrame: From pre-test (baseline) to 4 weeks post-intervention
measure: Change in Prenatal Distress Questionnaire (NuPDQ) scores
timeFrame: From pre-test (baseline) to 4 weeks post-intervention
measure: Change in State-Trait Anxiety Inventory (STAI-S-T) scores
timeFrame: From pre-test (baseline) to 4 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik Şehir Kadın Doğum Hastanesi
Study officials:
References: