Pregnancy, High RiskMeditateNCT03737279
Daily Meditation Program in Women Admitted to the Antepartum Unit
A study testing Meditation and Routine Care in people with Pregnancy, High Risk and Pregnancy Related, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to assess whether a daily mindful meditation program for women admitted to the antepartum floor will decrease maternal state anxiety compared to routine care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, High Risk, Pregnancy Related
- What is being tested?
- Meditation and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2019to 1 Apr 2020
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- ≥ 23.0 weeks gestation
- Planned inpatient care for > 3 days from randomization
- Women cared for by UT physicians
Who cannot join
- Known major lethal fetal anomalies (eg. trisomy 13, trisomy 18, anencephaly, Potter's Syndrome)
- Non-English speaking women
- Planned delivery ≤ 3 days from randomization
- Previous fetal surgery in the current pregnancy (twin twin transfusion syndrome laser ablation, spina bifida repair, etc)
- Women who have practiced a form of meditation in the current pregnancy (including yoga) in the last 4 weeks
- Women who are currently using patient-controlled analgesia (PCA) (eg. sickle cell crisis)
Show all 12Show fewer
- Admission diagnosis of ecclampsia or HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome
- Diagnosed personality disorder including borderline personality disorder, histrionic personality disorder, schizoid personality disorder, schizotypal personality disorder, schizophrenia
- Diagnosed anxiety, depression, bipolar or other psychiatric illness on medications for these disorders
- Non-reassuring fetal heart tracing on admission
- Intrauterine fetal demise at randomization
- Inability to gain access to phone application
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Daily Meditation Program in Women Admitted to the Antepartum Unit: A Randomized Controlled Trial
The purpose of this study is to assess whether a daily mindful meditation program for women admitted to the antepartum floor will decrease maternal state anxiety compared to routine care.
- Conditions
- Pregnancy, High Risk, Pregnancy Related
- Being tested
- Meditation, Routine Care
- Keywords
- Pregnancy, Meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
Routine care + twice daily meditation per schedule, to start on the day of randomization
Routine CareBehavioural
Routine care including ACOG educational pamphlets:
- Day 1: "Nutrition in Pregnancy"
- Day 2: "Heart Health for Women"
- Day 3: "Exercise after Pregnancy"
| Study group | Role | What they receive |
|---|---|---|
| Meditation | Experimental | Intervention Group:
Routine care plus twice daily mindful meditation Receives: Behavioral: Meditation; Behavioral: Routine Care |
| Routine care | Active comparator | Control Group:
Routine care which includes ACOG educational pamphlets on day 1, 2 and 3 after randomization Receives: Behavioral: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal state anxiety as assessed by the State Anxiety Scale
The State Anxiety Scale Ranges from 20 to 80, with higher scores indicating a higher anxiety level.
Measured: 1-3 days
Secondary outcomes (7)
Maternal state anxiety as assessed by the State Anxiety Scale
The State Anxiety Scale score ranges from 20 to 80, with higher scores indicating a higher anxiety level.
Measured: 1 to 11 weeks.
Stress as assessed by the Perceived Stress Scale
The Perceived Stress Scale score ranges from 0 to 40, with higher scores indicating a higher stress level.
Measured: 3 days to 11 weeks.
Depression as assessed by the Edinburgh Depression Scale
The Edinburgh Depression Scale score ranges from 0 to 30, with higher scores indicating a higher depression level.
Measured: 3 days to 11 weeks.
Patient satisfaction
The Patient satisfaction questionnaire will be scored by a 5-point Likert Scale. Two questions will be asked relating to overall experience with the research trial and overall experience in the hospital. Each of the two questions will be rated with a 5-point Likert, with a total score ranging from 2 to 10 and with higher scores indicating a [better/worse] outcome.
Measured: 3 days to 11 weeks.
Latency period
Latency period is defined as time from randomization until delivery
Measured: At delivery.
Number of meditation sessions
Meditation sessions as reported per patient and documented by phone application.
Measured: 11 weeks
Duration of meditation sessions
Meditation duration as reported per patient and documented by phone application.
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start4 Mar 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
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 Pregnancy, High RiskStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morgen Doty, The University of Texas Health Science Center, Houston
- Investigators
- Morgen S Doty, DO, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737279
- Sponsor's protocol ID
- HSC-MS-18-0810
- Acronym
- Meditate
- Status last verified
- Jun 2020
- First submitted
- 23 Oct 2018
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doty MS, Chen HY, Ajishegiri O, Sibai BM, Blackwell SC, Chauhan SP. Daily meditation program for anxiety in individuals admitted to the antepartum unit: a multicenter randomized controlled trial (MEDITATE). Am J Obstet Gynecol MFM. 2022 May;4(3):100562. doi: 10.1016/j.ajogmf.2022.100562. Epub 2022 Jan 12.
PubMed 35031521
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Meditation Program in Women Admitted to the Antepartum Unit: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03737279
- Acronym / sponsor ID
- Meditate / HSC-MS-18-0810
- Conditions
- Pregnancy, High Risk, Pregnancy Related
- Keywords
- Pregnancy, Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 9 Nov 2018 (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 assess whether a daily mindful meditation program for women admitted to the antepartum floor will decrease maternal state anxiety compared to routine care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation | Experimental | Behavioral: Meditation, Behavioral: Routine CareIntervention Group: Routine care plus twice daily mindful meditation |
| Routine care | Active comparator | Behavioral: Routine CareControl Group: Routine care which includes ACOG educational pamphlets on day 1, 2 and 3 after randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- ≥ 23.0 weeks gestation
- Planned inpatient care for > 3 days from randomization
- Women cared for by UT physicians
Key exclusion criteria (12 listed)
- Known major lethal fetal anomalies (eg. trisomy 13, trisomy 18, anencephaly, Potter's Syndrome)
- Non-English speaking women
- Planned delivery ≤ 3 days from randomization
- Previous fetal surgery in the current pregnancy (twin twin transfusion syndrome laser ablation, spina bifida repair, etc)
- Women who have practiced a form of meditation in the current pregnancy (including yoga) in the last 4 weeks
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 |
|---|---|---|
| MeditationRoutine care + twice daily meditation per schedule, to start on the day of randomization | Behavioural | Meditation |
| Routine CareRoutine care including ACOG educational pamphlets: * Day 1: "Nutrition in Pregnancy" * Day 2: "Heart Health for Women" * Day 3: "Exercise after Pregnancy" | Behavioural | Meditation, Routine care |
Primary outcome
Maternal state anxiety as assessed by the State Anxiety Scale
Time frame: 1-3 days
The State Anxiety Scale Ranges from 20 to 80, with higher scores indicating a higher anxiety level.
7 secondary outcomes
Maternal state anxiety as assessed by the State Anxiety Scale
Time frame: 1 to 11 weeks.
Stress as assessed by the Perceived Stress Scale
Time frame: 3 days to 11 weeks.
Depression as assessed by the Edinburgh Depression Scale
Time frame: 3 days to 11 weeks.
Patient satisfaction
Time frame: 3 days to 11 weeks.
Latency period
Time frame: At delivery.
Number of meditation sessions
Time frame: 11 weeks
Duration of meditation sessions
Time frame: 11 weeks
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 16 Jun 2020.
- Derived from this study: PubMed 35031521Doty MS, Chen HY, Ajishegiri O, Sibai BM, Blackwell SC, Chauhan SP. Daily meditation program for anxiety in individuals admitted to the antepartum unit: a multicenter randomized controlled trial (MEDITATE). Am J Obstet Gynecol MFM. 2022 May;4(3):100562. doi: 10.1016/j.ajogmf.2022.100562. Epub 2022 Jan 12.
- 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.
Morgen S Doty, DO principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation and Routine Care in people with Pregnancy, High Risk and Pregnancy Related, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 4 inclusion and 12 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 16 Jun 2020. 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 United States. 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?
Maternal state anxiety as assessed by the State Anxiety Scale (time frame: 1-3 days). 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 NCT03737279, 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 16 Jun 2020.