Miscarriage Clinical Trial
Official title:
Caring Interventions for Couples Who Have Miscarried
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.
The purpose of this randomized study is to compare the effects of nurse caring (3 nurse
counseling sessions), self-caring (3 home-delivered videotapes and journals), combined
caring (1 nurse counseling plus 3 videotapes and journals) and no intervention (control) on
the emotional healing, integration of loss, and couple well-being of women and their
partners (husbands or male mates) in the first year after miscarrying. A recent IoM [41]
report claims one of the greatest obstacles to determining effectiveness of home-based
interventions is getting clients to complete treatment protocols, thus the combined-caring
group is included to determine if nurse endorsement of the videotape/journal modules
enhances adherence and increases the efficacy of the self-caring protocol. All intervention
materials are based on Swanson's middle-range caring theory [109,112] and Meaning of
Miscarriage Model [116]. Both frameworks were phenomenologically derived and subsequently
applied and tested in the Miscarriage Caring Project (MCP), a randomized trial of the
effects of 3 caring-based nurse counseling sessions on women's emotional well-being and
integration of loss in the first year after miscarriage [115]. The MCP is the only
randomized post-miscarriage intervention that has led to significant positive mental health
outcomes for women.
There are no published studies of interventions that have led to significant outcomes for
men or couples post miscarriage. Yet, the PI's experience counseling couples groups (also
based on the caring theory and miscarriage model) has provided consistent, albeit anecdotal,
evidence that including partners helps couples to reach out to each other, integrate
miscarriage into their lives, and resolve grieving. Therefore, this project focuses on women
and their partners (spouses or male mates in a committed relationship). An additional goal
is to determine if an innovative, easily delivered, low-cost video/journal intervention is
as effective as interpersonal counseling in assisting women and their partners to
emotionally heal, integrate loss, and experience couple well being in the first year after
miscarriage.
The procedural aims are to:
1. Develop an empirically derived self-caring intervention for couples who have
miscarried. This home-delivered intervention will be a series of three modules
consisting of broadcast quality videotapes ("Miscarriage: Caring and Healing") and
journal assignments. (drafts are in Appendices B.1 to B.3.)
2. Train nurses to deliver a three session caring-based counseling intervention to
couples.
3. Randomly assign couples who recently miscarried to one of four groups: group I (nurse
caring) will receive three counseling sessions. Couples in group II (combined-caring)
will receive one counseling session plus three self-caring videotape / journal modules;
Group III (self-caring) will receive the three self-caring videotape / journal modules.
Group IV (control) will receive no intervention.
There are four hypothesis-testing specific aims and one exploratory research aim:
1. Compared to controls, women and their partners who receive nurse, combined, or
self-caring will report significantly more emotional healing, stronger integration of
loss, and greater couple well-being in the first year subsequent to miscarriage.
2. Comparing the three modes of delivering caring (nurse, combined, and self), for women
and their partners, there will be no differences in emotional healing, integration of
loss, and couple well-being
3. Comparing self-caring to combined-caring, for women and their partners, within and
across intervention times, there will be no differences in intervention adherence and /
or evaluation scores.
4. Comparing the nurse-caring group to the combined-caring group, for women and their
partners, there will be no differences in ratings of counselor empathy and caring at
the first counseling session.
5. Determine associations amongst background variables, intervention monitoring scores,
intervening variables, emotional healing, integration of loss, and couple well-being
for women and their partners at 1 week, 6 weeks, 4 months and 1 year post-enrollment.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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