The Effect of a Mindfulness-Based Stress Reduction Program Applied to Nulliparous Pregnant Women

ConditionPregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAmasya University

About this trial

Mindfulness-based stress reduction programs are among the effective methods that can contribute to managing anxiety during pregnancy, strengthening mother-fetus interaction, and supporting psychological well-being. In this context, this study will examine the effect of a mindfulness-based stress reduction program on prenatal anxiety, fetal health concerns, and psychological well-being. The aim of this study is to determine the effect of a mindfulness-based stress reduction program applied to pregnant women who have not previously given birth on prenatal anxiety, fetal health concerns, and psychological well-being.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Be 18 years of age and older,

Have at least a primary school graduate

Not having given birth before

Be between the 12th and 28th weeks of pregnancy,

Disqualifiers

Having any communication problems (language, hearing, vision, speech, etc.),

Having a diagnosis of high-risk pregnancy, or having a diagnosis of a psychiatric illness (depression, psychosis, etc.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention group (Mindfulness-Based Stress Reduction Program)

    Behavioral

    Pregnant women will be informed about the study and, after obtaining their written consent, pre-tests will be administered. Then, women in the intervention group will receive a Mindfulness-based stress reduction program for 4 weeks, with two sessions per week. The program will cover topics such as the physiology of pregnancy and the fetus, physiological and psychological changes in the mother during pregnancy, fetal development, adaptation to the maternal role, the concept and foundations of mindfulness, mindfulness applications, the use of mindfulness in daily life, the mindfulness approach during pregnancy, stress management methods, and mindfulness, relaxation, and breathing exercises. The training sessions will be planned in a practice-based manner to encourage active participation. Mindfulness exercises will be practiced in the sessions, and participants will be given homework assignments to encourage the application of mindfulness skills to daily life. The trainings will be condu

  • Control group

    Behavioral

    The control group will receive routine care. No interventions will be performed. Final tests will be administered 4 weeks after the preliminary tests.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Perinatal Anxiety Screening Scale

The Turkish validity and reliability study of the scale was conducted by Yazıcı et al. (2018). The scale consists of a total of 31 items and is a four-point Likert-type measurement tool. Items are scored with response options ranging from "never" to "always". Total scores above 16 indicate the presence of perinatal anxiety. As a result of the exploratory factor analysis, it was determined that the scale consists of four sub-dimensions. These sub-dimensions include: general anxiety and specific fears, perfectionism and control, social anxiety, general anxiety and adjustment difficulties, and acute anxiety, separation, and trauma. In the reliability analyses of the scale, Cronbach's alpha internal consistency coefficients were reported as 0.90, 0.89, 0.86, and 0.87 for the sub-dimensions, respectively.

Time frame
4 week
2

Fetal Health Anxiety Scale

The validity and reliability study of the Turkish Fetal Health Anxiety Inventory was conducted by Gökbulut et al. (2024). This inventory aims to assess the anxiety levels experienced by pregnant women regarding the health of the fetus. The FSKE consists of 14 items in total, each containing four different statements to reflect the experiences of pregnant women. Scores obtained from the scale range from 0 to 42, with a higher total score indicating a higher level of fetal health anxiety. When the psychometric properties of the Turkish form of the scale were examined, it was observed that the internal consistency reliability was reported as Cronbach's alpha coefficient of 0.85.

Time frame
4 week
3

Psychological Well-Being Scale

The Turkish adaptation of the scale was carried out by Telef (2013). The scale items have a seven-point Likert-type structure ranging from "strongly disagree" (1) to "strongly agree" (7). All statements in the scale are positively structured. The total scores that can be obtained from the scale range from 8 if all items are answered with "strongly disagree", and from 56 if all items are answered with "strongly agree". Higher scores indicate that the individual has higher levels of psychological resources and strengths. As a result of the reliability analyses of the scale, the Cronbach alpha internal consistency coefficient was determined as 0.80.

Time frame
4 week

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: