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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meditation | Experimental | Intervention Group: Routine care plus twice daily mindful meditation |
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| Routine care | Active Comparator | Control Group: Routine care which includes ACOG educational pamphlets on day 1, 2 and 3 after randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditation | Behavioral | Routine care + twice daily meditation per schedule, to start on the day of randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 to 11 weeks. |
| Stress as assessed by the Perceived Stress Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morgen S Doty, DO | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35031521 | Derived | 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. |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| Routine Care | Behavioral | Routine care including ACOG educational pamphlets:
|
|
The Perceived Stress Scale score ranges from 0 to 40, with higher scores indicating a higher stress level.
| 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. | 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. | 3 days to 11 weeks. |
| Latency period | Latency period is defined as time from randomization until delivery | At delivery. |
| Number of meditation sessions | Meditation sessions as reported per patient and documented by phone application. | 11 weeks |
| Duration of meditation sessions | Meditation duration as reported per patient and documented by phone application. | 11 weeks |
| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |