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

NCT02181595 | Terminated Phase 1

• 2 other identifiers: 14013914-CH-0139
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Insufficiency

Keywords

Reading; FACIT-SP; Primary Ovarian Insufficiency

Outcome Measures

Primary Outcomes (3)

• Feasibility based on Acceptability

  Recruitment Phase

• Feasibility based on Practicality of study

  throughout study

• Feasibility based on participant opinion

  end of study

Secondary Outcomes (1)

• Changes in FACIT-Sp measure of spiritual well-being

  weekly, 1 mon, 3 mon

Interventions

Group reading and discussion OTHER

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Puchalski C, Ferrell B, Virani R, Otis-Green S, Baird P, Bull J, Chochinov H, Handzo G, Nelson-Becker H, Prince-Paul M, Pugliese K, Sulmasy D. Improving the quality of spiritual care as a dimension of palliative care: the report of the Consensus Conference. J Palliat Med. 2009 Oct;12(10):885-904. doi: 10.1089/jpm.2009.0142.

  PMID: 19807235 BACKGROUND

• Boston P, Bruce A, Schreiber R. Existential suffering in the palliative care setting: an integrated literature review. J Pain Symptom Manage. 2011 Mar;41(3):604-18. doi: 10.1016/j.jpainsymman.2010.05.010. Epub 2010 Dec 8.

  PMID: 21145202 BACKGROUND

• Murillo M, Holland JC. Clinical practice guidelines for the management of psychosocial distress at the end of life. Palliat Support Care. 2004 Mar;2(1):65-77. doi: 10.1017/s1478951504040088.

  PMID: 16594236 BACKGROUND

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Margaret F Keil, C.R.N.P.

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 4, 2014
• Study Start: July 2, 2014
• Primary Completion: March 20, 2018
• Study Completion: March 20, 2018
• Last Updated: December 16, 2019

Record last verified: 2018-03-20

Locations

US (1)