Couples Miscarriage Healing Project:Randomized Trial

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.

Conditions

• Miscarriage
• Grief
• Pregnancy Loss

Interventions

BEHAVIORAL

Nurse Caring

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.

BEHAVIORAL

Self Caring

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.

BEHAVIORAL

Combined Caring

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.

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Kristen M Swanson, RN, PhD · University of Washington School of Nursing

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2001-09-30

Primary Completion

2006-06-30

Completion

2006-06-30

Countries

• United States

Study Locations