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

Deep Reading as a Contemplative Practice for Women With Primary Ovarian Insufficiency: An Exporatory Pilot Study.

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.

Study Overview

• Status: Terminated
• Conditions: Ovarian Insufficiency
• Intervention / Treatment: Other: Group reading and discussion

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility based on Acceptability	Recruitment Phase
Feasibility based on Practicality of study	throughout study
Feasibility based on participant opinion	end of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in FACIT-Sp measure of spiritual well-being	weekly, 1 mon, 3 mon

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 2, 2014
• Primary Completion (Actual): March 20, 2018
• Study Completion (Actual): March 20, 2018

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 2, 2014
• First Posted (Estimate): July 4, 2014

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: March 20, 2018

More Information

Terms related to this study

• Keywords: Reading; Primary Ovarian Insufficiency; FACIT-SP
• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: 140139; 14-CH-0139