AnxietyMINCT06136338
A Pilot Study of Mindfulness Intervention to the Timing of Labor Admission, Uncertainty and Anxiety
A study testing Mindfulness training in people with Anxiety and Uncertain Viability of Pregnancy, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Uncertain Viability of Pregnancy
- What is being tested?
- Mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Mar 2020to 9 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Uncertain Viability of Pregnancy
- Being tested
- Mindfulness training
- Keywords
- mindfulness-based intervention, childbirth related anxiety, childbirth related uncertainty
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness intervention group | Experimental | intervention + routine care Receives: Behavioral: Mindfulness training |
| Control group | No intervention | routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start23 Mar 2020
- Primary completion3 Mar 2023
- Study completion9 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group： intervention + routine care Control group：routine care
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chia-Wen Lee, National Taipei University of Nursing and Health Sciences
- Investigators
- LEE Chia-Wen, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136338
- Sponsor's protocol ID
- C109037
- Acronym
- MI
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness Intervention to Determine the Timing of Labor Admission, Uncertainty and Anxiety Among Pregnant Women: A Pilot Study.
- ClinicalTrials.gov ID
- NCT06136338
- Acronym / sponsor ID
- MI / C109037
- Conditions
- Anxiety, Uncertain Viability of Pregnancy
- Keywords
- mindfulness-based intervention, childbirth related anxiety, childbirth related uncertainty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 9 Apr 2023 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group： intervention + routine care Control group：routine care
| Arm | Type | Receives |
|---|---|---|
| Mindfulness intervention group | Experimental | Behavioral: Mindfulness trainingintervention + routine care |
| Control group | No intervention | –routine care |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness trainingWomen 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. | Behavioural | Mindfulness intervention group |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LEE Chia-Wen principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness training in people with Anxiety and Uncertain Viability of Pregnancy, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure of dispositional mindfulness on the Five Facets Mindfulness Questionnaire（FFMQ） (time frame: 28th week gestational, 34th gestational week and 3-days postpartum). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.