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NCT03712982 · ClinicalTrials.gov registry record · NA
Attention to Variability During Infertility
A NA study, sponsored by Harvard University.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
NCT03712982: Completed NA study, sponsored by Harvard University.
NCT03712982 is a NA study that has completed, run by Harvard University. The registered enrollment target is 70 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03712982, a NA study, has completed, sponsored by Harvard University.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
Study Summary
Infertility affects approximately one in seven couples, and it can be a devastating diagnosis and difficult experience for couples to endure. Ellen Langer, Ph.D., Director of the Langer Lab at Harvard, has spent several decades demonstrating evidence supporting a mind-body approach to improve wellbeing and overall functioning. Specifically, she asserts that Mindfulness in its most basic sense - paying attention in the moment - is enough to create both perceived (e.g., self-reported) and real (e.g., objective testing) change. Langer and her colleague, for example, demonstrated that "Trait mindfulness predicted the well-being of expecting mothers and better neonatal outcomes. Mindfulness training resulted in better health for the expecting mother". In this study, Mindfulness training refers to "attention to sensation variability." Such interventions are cost effective, minimally invasive, less time-consuming for practitioners and participants and generally easy to learn. Langer and her colleague's study refers to pregnancy. Infertility is unlike pregnancy in its exact clinical diagnosis. Nevertheless, similar to pregnancy, infertility is considered a clinical condition affecting the body, in this case the reproductive system. Therefore, based on the results of studies like Langer and her colleague's, that used participants with clinical conditions affecting the reproductive system, the investigators propose similar mindfulness intervention (attention to sensation variability) research with infertile individuals. However, the investigators intend to extend our examination to also include a treatment group with the partners of the infertile individuals, as little, if any research, has attempted to do so previously. The investigators hypothesize that state mindfulness (groups exposed to mindfulness intervention) will improve wellbeing in the infertile patient and her partner and that trait mindfulness will predict ability to become pregnant.
Primary Outcome
4 subscales, each ranging from 1-7, with 1 being 'Strongly Disagree' and 7 being 'Strongly Agree'. Subscales are 'Flexibility' (includes 4 items); 'Novelty Seeking' (6 items); 'Novelty Producing' (6 items); 'Engagement' (5 items). 7 items are reverse scored. To determine overall Mindfulness score, sum all items (items 1-21).
Interventions
- BEHAVIORAL Attention to Variability - Patient Only
- BEHAVIORAL Attention to Variability - Partner Only
- BEHAVIORAL Attention to Variability - Patient & Partner
- OTHER Infertility Stories - Reading
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2016-12-05 |
| Est. Completion | 2021-01-29 |
| Phase | NA |
What the finished NCT03712982 record still lists
NCT03712982 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Attention to Variability - Patient Only is the first listed.
NCT03712982 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03712982 about?
NCT03712982 is a clinical study titled "Attention to Variability During Infertility". Infertility affects approximately one in seven couples, and it can be a devastating diagnosis and difficult experience for couples to endure. Ellen Langer, Ph.D., Director of the Langer Lab at Harvard, has spent several decades demonstrating evidence supporting a mind-body approach to improve wellbe...
What is the current status of trial NCT03712982?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2016-12-05. Estimated completion is 2021-01-29.
What interventions are being tested in trial NCT03712982?
The interventions under investigation include: Attention to Variability - Patient Only (BEHAVIORAL), Attention to Variability - Partner Only (BEHAVIORAL), Attention to Variability - Patient & Partner (BEHAVIORAL), Infertility Stories - Reading (OTHER).
Who is sponsoring clinical trial NCT03712982?
This trial is sponsored by Harvard University, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03712982's enrollment target sits among peer trials
70 1103rd of 2000 higher than 868 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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