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Completed

NCT Number: NCT06136338

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Uncertain Viability of Pregnancy

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Taipei University of Nursing and Health

Taipei, 112303, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Mindfulness Training

Behavioral

Women in the experimental group underwent four sessions of mindfulness training. The mindfulness training started at the 28th week of pregnancy for the women, the second training was at the 30th week of pregnancy, the third was at the 32nd week of pregnancy, and the last was at the 34th week of pregnancy, with each session lasting 45 minutes.

Primary outcomes

  1. measure of dispositional mindfulness on the Five Facets Mindfulness Questionnaire（FFMQ）

    Time frame: 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.

  2. Uncertainty Visual Analogue Scale to measure the degree of uncertainty of women about admission to the hospital

    Time frame: 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.

  3. Anxiety Visual Analogue Scale to measure the women overall anxiety

    Time frame: 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.

  4. If women improve attention will help them to make decision, so measure of decision making ability on Attentional Control Scale(ACS)

    Time frame: 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.

  5. labor and childbirth information

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Registry information

Official study title

Effectiveness of Mindfulness Intervention to Determine the Timing of Labor Admission, Uncertainty and Anxiety Among Pregnant Women: A Pilot Study.

Acronym: MI

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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