Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194844
Status:
COMPLETED
Last Update Posted:
2008-02-18
First Post:
2005-09-13
Brief Title:
Couples Miscarriage Healing ProjectRandomized Trial
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Caring Interventions for Couples Who Have Miscarried
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Swansons 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
Detailed Description:
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 videotapejournal modules enhances adherence and increases the efficacy of the self-caring protocol All intervention materials are based on Swansons middle-range caring theory 109112 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 womens 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 PIs 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 videojournal 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 B1 to B3
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
There are no published studies of interventions that have led to significant outcomes for men or couples post miscarriage Yet the PIs 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 videojournal 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 B1 to B3
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01NR005343-04 | NIH | None | httpsreporternihgovquickSearch5R01NR005343-04 |