The Effect of Mindfulness-Based Stress Reduction Programme on Stress, Anxiety, Self-Compassion and Prenatal Attachment

NCT06850701 | Completed DMC

• 1 other identifier: KahramanmaraşSIU8
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This research will be conducted to examine the effects of a mindfulness-based stress reduction (MBSR) programme on stress, anxiety, self-compassion and prenatal attachment in pregnant women with perinatal loss. This randomised controlled trial was conducted with 80 pregnant women with perinatal loss (40 participants in the experimental group and 40 participants in the control group). The experimental group will receive a total of eight sessions of MBSR in two sessions per week for four weeks. The data of the study will be collected by Personal Information Form, Tilburg Distress in Pregnancy Scale, Self-Compassion Scale Short Form, Subjective Discomfort Unit Scale and Prenatal Maternal Attachment Scale.

Conditions

28 Weeks of Gestation; 18 Years and Over

Keywords

perinatal loss; midwifery

Outcome Measures

Primary Outcomes (3)

• Tilburg Distress in Pregnancy Scale

  It was developed by Pop et al. in the Netherlands in 2011 for the diagnosis of distress in pregnancy. It was translated into Turkish by Çapık in 2013 after a Turkish validity and reliability study. The scale consists of a total of 16 items. It is 4-point Likert type. The lowest score that can be obtained from the total scale is 0 and the highest score is 48. The scale has two sub-dimensions as 'Negative affect' and 'Partner involvement'. The scale can be applied to pregnant women aged 12 weeks and above. Cronbach's alpha coefficient of the original scale was 0.78. The Cronbach's alpha coefficient of the Turkish form of the scale is 0.80 (Çapık et al. 2015).

  1 month

• Self-Compassion Scale Short Form (SCS-SS-S)

  The Turkish validity and reliability of the scale developed by Neff (2003) was conducted by Yıldırım and Sarı (2018). The scale was found to have 11 items, a single dimension and a structure with complementary positive and negative components (Yıldırım \& Sarı, 2018). Neff (2015) used the scale in parents of children with ASD and reported that self-compassion can play an important role in the well-being of parents of children with autism. A total score is used in the SCS-C scale. An increase in the scores obtained from the scale indicates a high level of self-compassion. The internal consistency coefficient of the scale is 0.75 (Yıldırım \& Sarı, 2018) (ANNEX-10). In this study, the Cronbach Alpha internal consistency coefficient of the scale was 0.65 in the pretest and 0.66 in the posttest (Yıldırım \& Sarı, 2018).

  1 month

• Subjective Units of Disturbance Scale (SUDS)

  Developed by Wolpe, SUDS is used in energy therapies and assesses the individual's discomfort. The SUDS can be applied immediately before and at the end of the therapy. The score given serves as a concrete and basic point of departure regarding the condition of the individual at the beginning of the therapy and reflects the change at the end of the application. It has previously been used in energy therapy studies in our country (Dincer et al. 2023; Patterso, 2016). This scale is scored between 0 and 10, with 0 indicating no anxiety and 10 indicating high anxiety. As the number value increases, the discomfort experienced by the person becomes more severe. The numbers in the scale show the following statements (Wolpe, 1973).

  1 month

Study Arms (2)

Experimental

EXPERIMENTAL

mbsr

Behavioral: mbsr

control group

OTHER

THERE IS NO APPLICATION OF ANY KIND

Behavioral: mbsr

Interventions

mbsr BEHAVIORAL

In order to evaluate the effect of MBSR programme on stress, anxiety, self-compassion and prenatal attachment of pregnant women with perinatal pregnancy loss, MBSR will be applied for four weeks (two sessions per week) for a total of eight sessions in the experimental group. The intervention protocol of this study includes the entire MBSR programme consisting of two sessions per week for 1 month and homework assignments given throughout the programme. In all sessions, mindfulness exercises such as 3-minute breathing, body and breathing exercises, body scanning meditation, sitting meditation, mountain meditation, compassion meditation will be applied to the participants under the guidance of the researcher (H.G.Ö) who is trained and certified in the field of MBSR. It will be done in sessions and individual practices in an environment where pregnant women will not be disturbed at any time of the day. The live online MBSR programme will be provided through mobile communication tools. Sess

Experimental; control group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women who were between 10-28 weeks of gestation,
• had a prenatal diagnosis of pregnancy,

You may not qualify if:

• participation in mind-body practices or a different antenatal care programme during the study,
• unwillingness to participate in the sessions,

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaraş Sütçü İmama Universty

Kahramanmaraş Merkez, K.maraş, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: February 27, 2025
• Study Start: March 10, 2025
• Primary Completion: April 15, 2025
• Study Completion: June 15, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)