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NCT02181595 · ClinicalTrials.gov registry record · Phase 1
Deep Reading as a Contemplative Practice for Women With Primary Ovarian Insufficiency
A Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02181595 is a Phase 1 study that was terminated before completion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 6 participants.
The verdict
NCT02181595, a Phase 1 study, was terminated before completion, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Background: \- Women with Primary Ovarian Insufficiency (POI) have ovaries that stopped working normally before they turned 40. This usually causes infertility, which challenges many women with the condition to ask themselves, Why me? This kind of question is about our human existence, or what some call an existential view of life. Researchers have learned that spirituality and finding existential purpose help women with POI. So does meeting other women with the same problem. Researchers want to find new ways to help women with POI cope with it. Objective: \- To develop and test a practice for women with POI called Deep Reading. Eligibility: \- Women enrolled in another POI protocol, who can read and speak English. Design: * Participants will first have an individual visit or phone call. They will describe spiritual or existential practices they have done. They will also answer questions about spiritual and existential health and daily functioning. * They will join a group for 6 weekly sessions. Each session will be 60 90 minutes. * In each group session, a coordinator will teach participants about Deep Reading. They will read a piece of up to 1000 words. They will think about the piece and then talk about it with the group. * Between sessions, participants will practice Deep Reading at least once for 15 20 minutes on their own. They will check in once with another group member. They will keep a log of these activities. * After session 3, participants will answer questions online about wellbeing and satisfaction. * At session 6, participants will answer questions online about wellbeing. They will answer questions about their overall experience. * One and 3 months after the sessions end, participants will again complete online wellbeing questionnaires and report on their continued practice of Deep Reading.
Interventions
- OTHER Group reading and discussion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2014-07-02 |
| Est. Completion | 2018-03-20 |
| Phase | Phase 1 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02181595
The ClinicalTrials.gov registry entry for NCT02181595 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Group reading and discussion is the first listed.
NCT02181595 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02181595 about?
NCT02181595 is a clinical study titled "Deep Reading as a Contemplative Practice for Women With Primary Ovarian Insufficiency". Background: \- Women with Primary Ovarian Insufficiency (POI) have ovaries that stopped working normally before they turned 40. This usually causes infertility, which challenges many women with the condition to ask themselves, Why me? This kind of question is about our human existence, or what some...
What is the current status of trial NCT02181595?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2014-07-02. Estimated completion is 2018-03-20.
What interventions are being tested in trial NCT02181595?
The interventions under investigation include: Group reading and discussion (OTHER).
Who is sponsoring clinical trial NCT02181595?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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