The Effect of Mindful Awareness on Fear and Satisfaction... | NCT07320794

NCT07320794

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Detailed Description

The aim of this study is to conduct a randomized controlled experimental study to determine the effect of online mindfulness-based childbirth anxiety training on childbirth anxiety and birth satisfaction in pregnant women.

Detailed Description: Childbirth anxiety is a common problem among women and affects their health and well-being before, during, and after pregnancy.

This problem can lead to negative pregnancy outcomes and can also cause psychological problems for the woman.

Childbirth anxiety can also affect the choice of delivery method and lead to an increase in cesarean section rates.

Healthcare services provided by midwives and other healthcare professionals during pregnancy and childbirth have the power to reduce or increase childbirth anxiety.

The most important midwifery intervention that can be used to reduce childbirth anxiety is counseling. The importance of childbirth anxiety for the midwifery profession is clearly evident from the fact that women prefer more interventions during childbirth. Large epidemiological studies provide good evidence that women experiencing childbirth anxiety prefer interventions during childbirth. When mindfulness training is examined in general, it is seen that mindfulness-based interventions can be effective in increasing positive emotions and decreasing negative emotions. The use of mindfulness-based interventions is increasing day by day, and their clinical benefits are being proven by studies. In light of these studies, it can be said that the method can be used in women not only to reduce stress but also as an effective method with physiological benefits. It is necessary to increase basic mindfulness training for pregnant women, to include midwives in mindfulness-based interventions, to develop intervention programs for women's specific life stages by ensuring necessary collaborations, and to evaluate the results of these programs. Studies have indicated that mindfulness training during counseling increases women's self-esteem. With mindfulness training, pregnant women's sense of control and self-confidence during childbirth can be increased, and birth outcomes can be improved positively. This study was conducted to determine the effect of mindfulness-based childbirth fear management training given to women on childbirth fear and birth satisfaction. The hypothesis that there was no difference in the mean childbirth fear and satisfaction scores between the intervention and control groups after the intervention was tested.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Behavioral: Intervention group	Experimental	The mindfulness training was conducted over three weeks, with two sessions per week, for a total of six sessions. Pregnant women were given brochures and booklets prepared by the researcher, appropriate to the training content, before the training (Appendix 13). Pregnant women in the intervention group received training reminders via text message the day before the training and again via text message a few hours before the training, sometimes by phone. The training was conducted at times convenient for the pregnant women, with each session lasting 40-45 minutes. At least two weeks after the mindfulness training, data were collected online using the W-DEQ-A and mindfulness scales; those who could not be reached were administered face-to-face, and those who could not be reached were administered via text message. Between days 7 and 15 postpartum, the postpartum information form, the W-DEQ-B and mindfulness scales, and the birth satisfaction scale were administered to the women at times	Behavioral: Mindfulness-Based Childbirth Education
control group	No Intervention	No Intervention: Control group The control group continued to receive the routine care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness-Based Childbirth Education	Behavioral	The intervention consisted of a structured mindfulness-based childbirth education program delivered over three weeks, with two sessions per week (six sessions in total). Each session lasted approximately 40-45 minutes. The program aimed to reduce fear of childbirth and improve childbirth satisfaction. Educational materials were provided to participants, and reminder messages were sent before each session.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
2. Fear of childbirth after intervention	2. Fear of childbirth after intervention assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version A. This instrument contains questions on women's prenatal expectations to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel before their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version A is based on a 6-point Likert scale numbered 0-5. Zero corresponds to the response, "Totally" and five means "none." The minimum possible score on the scale is a "0"; maximum is 165. Higher scores indicate greater levels of Fear of Childbirth. [Time Frame: 36-38 gestational weeks]	[Time Frame: 37-40 gestational weeks]
Fear of childbirth before intervention	. Fear of childbirth before intervention assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version A. This instrument contains questions on women's prenatal expectations to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel before their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version A is based on a 6-point Likert scale numbered 0-5. Zero corresponds to the response, "Totally" and five means "none." The minimum possible score on the scale is a "0"; maximum is 165. Higher scores indicate greater levels of Fear of Childbirth.	[Time Frame: 28-32 gestational weeks
Fear of childbirth after birth	Fear of childbirth after birth assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version B. This instrument contains questions on women's postpartum experiences to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel after their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version-B is based on a 6- point Likert scale where the responses are numbered from 1-6 and one corresponds to the response, "Totally" and six means "none." The total possible score on the scale varies between 33-198. Higher scores indicate greater levels of Fear of Childbirth.

Secondary Outcomes

Measure	Description	Time Frame
The Mindfulness Scale	The Mindfulness Scale is a 15-item scale that measures the general tendency to be aware of and attentive to present experiences in daily life. The scale has a single-factor structure and gives a single total score. Higher scores on the scale indicate higher mindfulness. The scale is a 6-point Likert-type scale (Almost always, most of the time, sometimes, rarely, quite rarely, almost never).

Eligibility Module