Clinical trial NCT06136338: A Pilot Study of Mindfulness Intervention to the Timing of Labor Admission, Uncertainty and Anxiety
Official title: Effectiveness of Mindfulness Intervention to Determine the Timing of Labor Admission, Uncertainty and Anxiety Among Pregnant Women: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Uncertain Viability of Pregnancy
Keywords: mindfulness-based intervention
childbirth related anxiety
childbirth related uncertainty
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 31
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group： intervention + routine care Control group：routine care
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: measure of dispositional mindfulness on the Five Facets Mindfulness Questionnaire（FFMQ）
timeFrame: 28th week gestational, 34th gestational week and 3-days postpartum
measure: Uncertainty Visual Analogue Scale to measure the degree of uncertainty of women about admission to the hospital
timeFrame: 28th week gestational, 34th gestational week and 3-days postpartum
measure: Anxiety Visual Analogue Scale to measure the women overall anxiety
timeFrame: 28th week gestational, 34th gestational week and 3-days postpartum
measure: If women improve attention will help them to make decision, so measure of decision making ability on Attentional Control Scale(ACS)
timeFrame: 28th week gestational, 34th gestational week and 3-days postpartum
measure: labor and childbirth information
timeFrame: 3-days postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taipei University of Nursing and Health
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: LEE Chia-Wen
role: PRINCIPAL_INVESTIGATOR
References: