A Pilot Study of Mindfulness Intervention to the Timing of Labor Admission, Uncertainty and Anxiety

Not Applicable

Completed

• Conditions: Uncertain Viability of Pregnancy; Anxiety
• Interventions: Behavioral: Mindfulness training

• Registration Number: NCT06136338
• Lead Sponsor: National Taipei University of Nursing and Health Sciences

Brief Summary

The goal of this quasi-experienmental study is to investigate the effectiveness of mindfulness-based intervention in the level of uncertainty and anxiety, and determintation towards hospital admission among pregnant women. The main questions : • Do pregnant women in intervention group reduce anxiety and uncertainty? • Do pregnant women in intervention group increase self-determintation ability towards hospital admission? Women in the intervention group participated 4 weeks mindfulness-based intervention online courses, Researchers have seen effectiveness of mindfulness-based intervention in the level of uncertainty, anxiety, and determintation towards hospital admission among pregnant women.

Detailed Description

The aim of this study is to investigate the effectiness of mindfulness-based intervention in the level of uncertainty and anxiety, and determination towards hospital admission among pregnant women. This study is a quasi-experimental design and convenient sampling to recruit primipara women in the distrct hospital. A total of 31 participants were enrolled, eleven participatns were assigned to the experimental group, and twenty participants were in the control group. The measurements were demographic characteristics andobstetric data, FFMQ,VAS of uncertainty and anxiety, and ACS.

Study Timeline

• Study Start: 2020-03-23
• Primary Completion: 2023-03-03
• Study Completion: 2023-04-09
• Status Verified: 2023-11
• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-14
• Last Update Submitted: 2023-11-14
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

1. At least 20 years old.
2. Single primiparous women with gestation over 28 weeks.
3. Clear consciousness, ability to speak, write and read Chinese, able to write questionnaires by themselves.
4. Those who are expected to have a vaginal delivery.
5. Agree to participate in the researcher after the research description.

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Exclusion Criteria

1. People with mental health problems, such as: depression, mental illness, etc.
2. The woman has pregnancy complications or the fetus has any complications.
3. Arrange for labor induction.
4. Those who have meditated or attended mindfulness courses.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness intervention group	Mindfulness training	intervention + routine care

Primary Outcome Measures

Name	Time	Method
labor and childbirth information	3-days postpartum	This part of the information is transcribed from the medical records. Data include: who decides to be admitted to the hospital, how many time was admissions rejections, the situation of the first vaginal examination when admitted to the hospital, and the uterus contraction pressure and frequency, duration of labor, labor-inducing drugs, epidural pain relief usage, delivery method, assisted delivery.
If women improve attention will help them to make decision, so measure of decision making ability on Attentional Control Scale(ACS)	28th week gestational, 34th gestational week and 3-days postpartum	The Attentional Control Scale (ACS) measures the ability to focus attention, to shift attention between tasks, and to flexibly control one's thoughts.This 20-item, self-report questionnaire examines one's ability to control one's attention.Participants answered questions based on a four-point scale ranging from almost never to always. The total score range from 20-80, higher scores mean a better outcome.
measure of dispositional mindfulness on the Five Facets Mindfulness Questionnaire（FFMQ）	28th week gestational, 34th gestational week and 3-days postpartum	The Five Facet Mindfulness Questionnaire(FFMQ) is a 39-item self-report measure of dispositional mindfulness. The scale is comprised of five factors: Observing, describing, acting with awareness, nonjudging, and nonreacting. The FFMQ has demonstrated strong psychometric properties.Each item is rated on a five-point Likert-type scale ranging from never or very rarely true to very often or always true. The total score range from 39-195, higher scores mean a better outcome.
Anxiety Visual Analogue Scale to measure the women overall anxiety	28th week gestational, 34th gestational week and 3-days postpartum	This study uses a visual analog scale of 0-10 points, the score ranges from 0 to 10 points, the higher score, means the women is more anxiety.
Uncertainty Visual Analogue Scale to measure the degree of uncertainty of women about admission to the hospital	28th week gestational, 34th gestational week and 3-days postpartum	This study uses a visual analog scale of 0-10 points, the score ranges from 0 to 10 points, the higher score, means the women is more sense of uncertainty.

Trial Locations

Locations (1)

National Taipei University of Nursing and Health; 🇨🇳 Taipei, Taiwan