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

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Uncertain Viability of Pregnancy
• Intervention / Treatment: Behavioral: Mindfulness training

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112303
    • National Taipei University of Nursing and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; routine care
Experimental: Mindfulness intervention group; intervention + routine care	Behavioral: Mindfulness training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Investigators: Principal Investigator: LEE Chia-Wen, National Taipei University of Nursing and Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2020
• Primary Completion (Actual): March 3, 2023
• Study Completion (Actual): April 9, 2023

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: mindfulness-based intervention; childbirth related anxiety; childbirth related uncertainty
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: C109037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No