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

NCT06136338 | Completed DMC

• 1 other identifier: C109037
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Uncertain Viability of Pregnancy

Keywords

mindfulness-based intervention; childbirth related anxiety; childbirth related uncertainty

Outcome Measures

Primary Outcomes (5)

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

  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.

  28th week gestational, 34th gestational week and 3-days postpartum

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

  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.

  28th week gestational, 34th gestational week and 3-days postpartum

• Anxiety Visual Analogue Scale to measure the women overall anxiety

  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.

  28th week gestational, 34th gestational week and 3-days postpartum

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

  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.

  28th week gestational, 34th gestational week and 3-days postpartum

• labor and childbirth information

  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.

  3-days postpartum

Study Arms (2)

Mindfulness intervention group

EXPERIMENTAL

intervention + routine care

Behavioral: Mindfulness training

Control group

NO INTERVENTION

routine care

Interventions

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.

Mindfulness intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

National Taipei University of Nursing and Health

Taipei, 112303, Taiwan

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• LEE Chia-Wen

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Experimental group： intervention + routine care Control group：routine care

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 18, 2023
• Study Start: March 23, 2020
• Primary Completion: March 3, 2023
• Study Completion: April 9, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)