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| Name | Class |
|---|---|
| Mount Zion Health Fund | OTHER |
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The purpose of this small randomized controlled trial (RCT) is to compare the impact of a brief (16 hour) 3rd trimester mindfulness-based childbirth education program, "Mind in Labor (MIL): Working with Pain in Childbirth," with a standard care/"treatment as usual" (TAU) active control condition of standard hospital- and community-based childbirth education. The MIL group is expected to demonstrate a reduction in fear of labor (less pain catastrophizing and greater childbirth self-efficacy), less perceived pain in labor, less use of pain medication in labor, greater birth satisfaction, and better prenatal and postpartum psychological adjustment compared to the TAU group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mind in Labor (MIL) | Experimental | Mind in Labor: Working with Pain in Childbirth (MIL) is a 16-hour mindfulness-based childbirth education course. It is an abbreviated weekend workshop form of the 9-week Mindfulness-Based Childbirth and Parenting (MBCP) education program, which is a tailored form of Mindfulness-Based Stress Reduction. |
|
| Treatment As Usual (TAU) | Active Comparator | Treatment As Usual (TAU) refers to standard hospital- and community-based childbirth preparation courses (high quality childbirth education that excludes a mindfulness or mind/body stress reduction focus). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind in Labor (MIL): Working with Pain in Childbirth | Behavioral | The Mind in Labor (MIL) mindfulness intervention for pregnant women and their partners integrates mindfulness strategies for coping with labor pain and fear and formal mindfulness meditation with traditional childbirth education. The MIL intervention is held over 3 consecutive weekend days (Friday - Sunday) for a total of 16 hours of mindfulness skills training for childbirth preparation and labor pain management. Mindfulness strategies for coping with labor-related pain and fear are taught in an interactive, experiential format, with periods of didactic instruction. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fear of labor (childbirth self-efficacy and pain catastrophizing) | Change in levels of self-reported childbirth self-efficacy and pain catastrophizing | Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth) |
| Perceived labor pain | Retrospective self-report of perceived pain in labor | Postpartum (average of 6 weeks post-birth) |
| Pain medication use during labor | Type, dose, and frequency of pain medication use during labor and delivery, recorded in medical record. | Labor (during childbirth) |
| Childbirth satisfaction | Self-reported satisfaction with experiences of childbirth | Postpartum (average of 6 weeks post-birth) |
| Change in Depression | Self-reported depressive mood/symptoms of depression | Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth) |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived stress and parenting stress | Change in and level of self-report of general perceived life stress and parenting-specific stress | Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth) |
| Mindfulness and interoceptive body awareness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larissa G Duncan, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Osher Center for Integrative Medicine | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34231203 | Derived | O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2. | |
| 33059638 | Derived | Sbrilli MD, Duncan LG, Laurent HK. Effects of prenatal mindfulness-based childbirth education on child-bearers' trajectories of distress: a randomized control trial. BMC Pregnancy Childbirth. 2020 Oct 15;20(1):623. doi: 10.1186/s12884-020-03318-8. |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D036801 | Parturition |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D011247 | Pregnancy |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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| Treatment as usual (TAU) | Behavioral | The treatment as usual "TAU" active comparison condition includes participation in a standard care childbirth education course, chosen by participants in the TAU arm from a pre-approved list of hospital- and community-based childbirth education courses comparable in length and quality to MIL, but without any mindfulness meditation, mindful movement/yoga, or other core mind/body component (e.g., hypnosis). |
|
Change in and level of self-report mindfulness in everyday life and interoceptive body awareness |
| Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth) |
| Positive and negative emotion | Change in and level of self-report of intensity and frequency of positive and negative affect | Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth) |
| Anxiety | Change in and level of self-report of trait anxiety, pregnancy-related anxiety, and worry | Baseline (pre-intervention, 3rd trimester); Post-intervention (prior to birth); Postpartum (average of 6 weeks postbirth); Follow-up (1-2 years post-birth) |
| 28499376 | Derived | Duncan LG, Cohn MA, Chao MT, Cook JG, Riccobono J, Bardacke N. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison. BMC Pregnancy Childbirth. 2017 May 12;17(1):140. doi: 10.1186/s12884-017-1319-3. |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |