Stress, PsychologicalNCT03185910
Mindfulness-Based Childbirth and Parenting Education on Pregnant Women
A study testing MBCP education and Hospital-based antenatal education in people with Stress, Psychological and Pregnancy Related, run by National Taipei University of Nursing and Health Sciences.
Trial summary
The purpose of this study is to explore the differences between stress, depression, childbirth self-efficacy, mindfulness and postnatal maternal outcomes in pregnant women with Mindfulness-Based Childbirth and Parenting education program. 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
- Stress, Psychological, Pregnancy Related
- What is being tested?
- MBCP education and Hospital-based antenatal education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2016to 28 Feb 2018
- 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
- Subjects were pregnant from 13th to 28th weeks gestation with a singleton pregnancy
- Subjects were at the age over 20
- Could speak and read Chinese fluently
- Willing and be able to attend the education program
- Determined to have a vaginal birth
Who cannot join
- Taking medication for diagnosing mental illness
- With complicated or high-risk pregnancies
About this study
Official title: The Efficacy of a Mindfulness-Based Childbirth and Parenting Education on Pregnant Women's Childbirth Self-efficacy, Psychological Health and Maternal Outcomes: A Randomized Controlled Trial
The purpose of this study is to explore the differences between stress, depression, childbirth self-efficacy, mindfulness and postnatal maternal outcomes in pregnant women with Mindfulness-Based Childbirth and Parenting education program.
Read the detailed description
Being a mother is a huge change for women, and she will undergo a high degree of change and a strong threat in this transformation process. The purpose of this study is to explore the efficacy of a Mindfulness-Based Childbirth and Parenting(MBCP) Education Program on prenatal stress, depression, mindfulness, childbirth self-efficacy, and postnatal maternal outcomes.
Randomized Controlled Trial comparing two education programs with health and singleton pregnant women is run by the Random Allocation Software (Saghaei, 2004). Use the G-Power 3.1.9 windows: repeated measures and between factors among two groups to calculate the number of samples, and setting the power = .8, α = .05, effect size = .25. The estimated number of samples may be lost 20%, total 104 samples ( 52 samples in each group).
The protocol for the study used MBCP education, this program helps participants practice in the present moment, so that they may develop more confidence and well-being during pregnancy. The MBCP course is held for 3 hrs once a week for 8 weeks. They also had the home practice of 30 minutes a day with a DVD for the experimental group. The control group attending a hospital-based antenatal education program for 2 hrs once a month for 2 months from hospital staff nurses in all aspects of pregnancy, childbirth and postpartum. This study uses a standard verbal script to the eligible participants who were volunteers of pregnant women in the waiting room of metropolitan hospital in Taiwan.
- Conditions
- Stress, Psychological, Pregnancy Related
- Being tested
- MBCP education, Hospital-based antenatal education
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCP educationBehavioural
MBCP education involves mindfulness breathing and other skills with mindfulness meditations.
Hospital-based antenatal educationBehavioural
Hospital-based antenatal education involves all aspects of pregnancy, childbirth and postpartum.
| Study group | Role | What they receive |
|---|---|---|
| MBCP education | Experimental | The intervention includes 3-hour classes per week during the duration of eight weeks and a 7- hour silent meditation practice as well. Receives: Behavioral: MBCP education |
| Hospital-based antenatal education | Placebo comparator | Hospital-based antenatal education program will be held 2 hrs once a month for 2 months. Receives: Behavioral: Hospital-based antenatal education |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of prenatal and postnatal stress
Self reported the perception of stress change from baseline to 6 months after childbirth using The Perceived Stress Scale
Measured: Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
Secondary outcomes (4)
postpartum medical records
This instrument was to explore whether recording of pregnancy outcome in medical records
Measured: After the childbirth within 24 hours will be collected
change of symptoms with depression and anxiety
Self reported the symptoms with depression and anxiety change from baseline to 6 months after childbirth using the Edinburgh Postnatal Depression Scale
Measured: Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
change of the childbirth self-efficacy
Self reported the childbirth self-efficacy change from baseline to 6 months after childbirth using the Childbirth Self-Efficacy Inventory
Measured: Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
change of mindfulness
Self reported the mindfulness change from baseline to 6 months after childbirth using Five Factor Mindfulness Questionnaire
Measured: Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start3 Feb 2016
- Primary completion2 Dec 2017 (estimated)
- Study completion28 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 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, Wan-Lin Pan, National Taipei University of Nursing and Health Sciences
- Investigators
- Wan-Lin Pan, MD, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185910
- Sponsor's protocol ID
- 104-E-20
- Status last verified
- Jun 2017
- First submitted
- 27 May 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pan WL, Chang CW, Chen SM, Gau ML. Assessing the effectiveness of mindfulness-based programs on mental health during pregnancy and early motherhood - a randomized control trial. BMC Pregnancy Childbirth. 2019 Oct 10;19(1):346. doi: 10.1186/s12884-019-2503-4.
PubMed 31601170
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Mindfulness-Based Childbirth and Parenting Education on Pregnant Women's Childbirth Self-efficacy, Psychological Health and Maternal Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03185910
- Acronym / sponsor ID
- 104-E-20
- Conditions
- Stress, Psychological, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 3 Feb 2016 (actual)
- Primary completion
- 2 Dec 2017 (estimated)
- Study completion
- 28 Feb 2018 (estimated)
- First posted
- 14 Jun 2017 (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 purpose of this study is to explore the differences between stress, depression, childbirth self-efficacy, mindfulness and postnatal maternal outcomes in pregnant women with Mindfulness-Based Childbirth and Parenting education program.
Detailed description
Being a mother is a huge change for women, and she will undergo a high degree of change and a strong threat in this transformation process. The purpose of this study is to explore the efficacy of a Mindfulness-Based Childbirth and Parenting(MBCP) Education Program on prenatal stress, depression, mindfulness, childbirth self-efficacy, and postnatal maternal outcomes.
Randomized Controlled Trial comparing two education programs with health and singleton pregnant women is run by the Random Allocation Software (Saghaei, 2004). Use the G-Power 3.1.9 windows: repeated measures and between factors among two groups to calculate the number of samples, and setting the power = .8, α = .05, effect size = .25. The estimated number of samples may be lost 20%, total 104 samples ( 52 samples in each group).
The protocol for the study used MBCP education, this program helps participants practice in the present moment, so that they may develop more confidence and well-being during pregnancy. The MBCP course is held for 3 hrs once a week for 8 weeks. They also had the home practice of 30 minutes a day with a DVD for the experimental group. The control group attending a hospital-based antenatal education program for 2 hrs once a month for 2 months from hospital staff nurses in all aspects of pregnancy, childbirth and postpartum. This study uses a standard verbal script to the eligible participants who were volunteers of pregnant women in the waiting room of metropolitan hospital in Taiwan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBCP education | Experimental | Behavioral: MBCP educationThe intervention includes 3-hour classes per week during the duration of eight weeks and a 7- hour silent meditation practice as well. |
| Hospital-based antenatal education | Placebo comparator | Behavioral: Hospital-based antenatal educationHospital-based antenatal education program will be held 2 hrs once a month for 2 months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects were pregnant from 13th to 28th weeks gestation with a singleton pregnancy
- Subjects were at the age over 20
- Could speak and read Chinese fluently
- Willing and be able to attend the education program
- Determined to have a vaginal birth
Key exclusion criteria (2 listed)
- Taking medication for diagnosing mental illness
- With complicated or high-risk pregnancies
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 |
|---|---|---|
| MBCP educationMBCP education involves mindfulness breathing and other skills with mindfulness meditations. | Behavioural | MBCP education |
| Hospital-based antenatal educationHospital-based antenatal education involves all aspects of pregnancy, childbirth and postpartum. | Behavioural | Hospital-based antenatal education |
Primary outcome
change of prenatal and postnatal stress
Time frame: Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
Self reported the perception of stress change from baseline to 6 months after childbirth using The Perceived Stress Scale
4 secondary outcomes
postpartum medical records
Time frame: After the childbirth within 24 hours will be collected
change of symptoms with depression and anxiety
Time frame: Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
change of the childbirth self-efficacy
Time frame: Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
change of mindfulness
Time frame: Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Derived from this study: PubMed 31601170Pan WL, Chang CW, Chen SM, Gau ML. Assessing the effectiveness of mindfulness-based programs on mental health during pregnancy and early motherhood - a randomized control trial. BMC Pregnancy Childbirth. 2019 Oct 10;19(1):346. doi: 10.1186/s12884-019-2503-4.
- 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.
Wan-Lin Pan, MD principal investigator
National Taipei University of Nursing and Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing MBCP education and Hospital-based antenatal education in people with Stress, Psychological and Pregnancy Related, run by National Taipei University of Nursing and Health Sciences.
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 2 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: status not confirmed, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
change of prenatal and postnatal stress (time frame: Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185910, which also lists 1 linked publication.
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 14 Jun 2017.