Effect of the Mindfulness-Based Stress Reduction Program on Prenatal Attachment, Distress and Anxiety Levels in Pregnant Women With Gestational Diabetes

NCT06960109 | Completed

• 1 other identifier: AEŞH-EK1-2023-267
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus (GDM); Mindfulness; Prenatal Attachment; Distress; Anxiety

Keywords

Gestational Diabetes Mellitus; Mindfulness; Prenatal attachment; Prenatal Distress; Anxiety; Midwifery

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  From pre-test (baseline) to 4 weeks post-intervention

Study Arms (2)

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.

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.

Interventions

A Mindfulness-Based Stress Reduction Program for Pregnant Women with Gestational Diabetes BEHAVIORAL

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

Intervention group: Mindfulness-Based Stress Reduction Program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Ankara Etlik Şehir Kadın Doğum Hastanesi

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, Gestational; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: May 7, 2025
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)