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Trial record 2 of 12 for:    Premature Ovarian Failure 14

Deep Reading as a Contemplative Practice for Women With Primary Ovarian Insufficiency

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ClinicalTrials.gov Identifier: NCT02181595
Recruitment Status : Terminated
First Posted : July 4, 2014
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Insufficiency Other: Group reading and discussion Phase 1

Detailed Description:
It is well documented in the literature that women with Primary Ovarian Insufficiency find spirituality a valuable resource for coping with the existential dimension of the diagnosis. This is an exploratory pilot study which examines reading as a contemplative practice to assist these women as they attempt to come to terms with the life altering aspects of living with the diagnosis. In this intervention, that we call Deep Reading, up to 15 participants will engage in six weekly sessions approximately sixty to ninety minutes in length in which they will receive instruction on aspects of Deep Reading, practice Deep Reading and process the experience. Between group sessions participants will be asked to practice Deep Reading on their own and be paired for mutual support and encouragement. For convenience participants will be recruited from among those already enrolled in NICHD Protocol, Ovarian Follicle Function in Patients with Primary Ovarian Insufficiency (91-CH-0127). We will use the FACIT-Sp and satisfaction questionnaires to measure participant response and feasibility for future study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Deep Reading as a Contemplative Practice for Women With Primary Ovarian Insufficiency: An Exporatory Pilot Study.
Study Start Date : July 2, 2014
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : March 20, 2018





Primary Outcome Measures :
  1. Feasibility based on Acceptability [ Time Frame: Recruitment Phase ]
  2. Feasibility based on Practicality of study [ Time Frame: throughout study ]
  3. Feasibility based on participant opinion [ Time Frame: end of study ]

Secondary Outcome Measures :
  1. Changes in FACIT-Sp measure of spiritual well-being [ Time Frame: weekly, 1 mon, 3 mon ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

To be eligible for this research study, subjects must:

  • have previously enrolled in NICHD study 91-CH-0127, Ovarian Follicle Function in Patients with Primary Ovarian Insufficiency
  • agree to practice Deep Reading at least once each week outside of group sessions
  • agree to respect the privacy and confidentiality of other participants

EXCLUSION CRITERIA:

The following will be excluding from participating in the study:

  • those unable to give consent
  • those unwilling to participate in 6, 90 minute group sessions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181595


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Margaret F Keil, C.R.N.P. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications:
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Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT02181595     History of Changes
Other Study ID Numbers: 140139
14-CH-0139
First Posted: July 4, 2014    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: March 20, 2018
Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
Reading
FACIT-SP
Primary Ovarian Insufficiency
Additional relevant MeSH terms:
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Primary Ovarian Insufficiency
Menopause, Premature
Ovarian Diseases
Gonadal Dysgenesis
Turner Syndrome
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn