NCT00194844

Brief Summary

This is a randomized trial of three caring based interventions to see if we can help couples heal after miscarriage. All three are based on Swanson's theory of caring and Meaning of Miscarriage Model. The first, nurse caring, consists of three counseling sessions with a nurse. The second intervention, self-caring, involves watching three videotapes and completing three workbooks. The third, combined caring, involves receiving one counseling session with a nurse followed up with the three videotapes and workbooks. There is also a control group that receives no intervention. All interventions are administered at 1, 6, and 11 weeks after study enrollment. Couples can enroll who are no more than 12 weeks post miscarriage of a pregnancy that ended at 20 weeks gestation or less. At 1, 6, 16, and 52 weeks post enrollment we ask couples to complete mailed booklets that contain a variety of research questionnaires about their emotional health, integration of loss, and couple relationship.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
682

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

February 18, 2008

Status Verified

February 1, 2008

Enrollment Period

4.8 years

First QC Date

September 13, 2005

Last Update Submit

February 15, 2008

Conditions

MiscarriageGriefPregnancy Loss

Keywords

caringmiscarriagegriefcouplescounseling

Outcome Measures

Primary Outcomes (1)

  • Nikcevic Miscarriage Grief Inventory

    first year after miscarriage

Secondary Outcomes (2)

  • Depression(CES-D); Mood Disturbances(POMS); Coping (Modified Folkman and Lazarus Ways of Coping); Emotional Strength (Swanson); Impact of Miscarriage (Swanson)

    first year after miscarriage

  • Couple relationship Mate Caring (Swanson); Support of Mate and Others (Brown); Intimacy (PAIR); Professional Caring (Swanson)

    first year after miscarriage

Study Arms (4)

1

EXPERIMENTAL

Nurse Caring

Behavioral: Nurse Caring

2

EXPERIMENTAL

Self Caring

Behavioral: Self Caring

3

EXPERIMENTAL

Combined Caring

Behavioral: Combined Caring

4

NO INTERVENTION

This group is not treated and serves as control.

Interventions

Nurse CaringBEHAVIORAL

Nurse Caring: Couples receive three one hour counseling session with a nurse interventionist at approximately 1, 5 and 11 weeks after enrollment. Content for the intervention comes from Swanson's phenomenologically derived Meaning of Miscarriage Model. The process for the intervention is based on Swanson's Theory of Caring.

1
Self CaringBEHAVIORAL

Self Caring: Couples receive a mailed videotape and workbook at approximately 1, 5 and 11 weeks after enrollment. Content for the intervention comes from Swanson's phenomenologically derived Meaning of Miscarriage Model. The process for the intervention is based on Swanson's Theory of Caring.

2
Combined CaringBEHAVIORAL

Combined Caring: Couples receive one counseling session from a nurse interventionist at approximately one week after enrollment. Upon completion of the session the nurse will hand the couple a self-caring videotape and workbook. Couples will be mailed an additional videotape and workbook at approximately 5 and 11 weeks after enrollment. Content for the intervention comes from Swanson's phenomenologically derived Meaning of Miscarriage Model. The process for the intervention is based on Swanson's Theory of Caring.

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unexpected, unplanned loss of pregnancy prior to 20 weeks gestation
  • no more than 12 weeks post loss
  • both the woman who miscarried and her male mate agree to participate
  • able to read, write, and speak in English
  • If 18 or older in a self proclaimed committed heterosexual relationship
  • If married, may be under 18

You may not qualify if:

  • non heterosexual couples
  • not geographically accessible to the Puget Sound area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington School of Nursing

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Kristen M Swanson, RN, PhD

    University of Washington School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

September 1, 2001

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

February 18, 2008

Record last verified: 2008-02

Locations

US(1)