Care in Women With History of Recurrent Miscarriage Clinical Trial
Official title:
Effectiveness of Nursing Counseling on Stress and Depression for Women With Recurrent Miscarriage: A Randomized Controlled Pilot Study
Recurrent miscarriage is a frustrating event for couples. The purpose of this randomized, controlled trial was to examine the effectiveness of nursing counseling on sleep quality, depression, stress, and social support in women with recurrent miscarriage (RM). Sixty-two eligible women were randomly assigned to the experimental group (n = 31) or the control (n = 31) group. The experimental group received routine care and three sessions of nursing counseling during the 12-week prenatal genetic testing stage, while the control group received routine care only. Outcome measures included the Pittsburgh Sleep Quality Index, Edinburgh Prenatal Depression Scale, Perceived Stress Scale, and Interpersonal Support Evaluation List. Paired sample t-tests were conducted before and after nursing counseling to measure whether there were any statistically significant changes in outcome variables.
2.1 | Design and sample A single-blind, randomized, controlled trial with a prospective
pretest-posttest experimental design was used. Prospective participants were recruited from
the obstetrics and gynecology clinic of a medical center in southern Taiwan. The inclusion
criteria were (1) having experienced at least two consecutive miscarriages and (2) providing
informed consent to participate. A convenience sample of 62 women meeting the inclusion
criteria were enrolled in this study as participants.
2.2 | Intervention The nursing counseling intervention was implemented by a maternity nursing
instructor. During the 12-week prenatal genetic testing evaluation period, experimental-group
participants received three nursing consultation sessions plus regular care, while their
control-group peers received regular care only. The counseling intervention was designed to
facilitate self-awareness, reduce self-blame, clarify doubts, listen to patient concerns,
promote forward thinking, and encourage life planning.
2.4 | Procedure and ethical considerations This study was conducted between October 2016 and
January 2018 after approval had been obtained from the research ethics committee of the
participating institution. The objectives of this study and the rights of participants were
fully explained to each participant. Participation in this study was voluntary, and refusal
to participate had no impact on subsequent access to or quality of care.
The 62 women who met the inclusion criteria were assigned systematically from a random
starting point using a week as the unit (Yang & Chen, 2018) to either the experimental group
(n = 31) or the control group (n = 31). To avoid contaminating data by allowing participants
to communicate with one another during the prenatal genetic testing evaluation, data were
collected on the first week from experimental-group participants, who were selected by a
research assistant who draw lots (E for experimental group and C for control group) from a
sack. Subsequently, the group allotment for the following week was systematically assigned in
sequence to either the control group or the experimental group. All of the participants
completed the Demographic Data Form, PSQI, EPDS, PSS, and ISEL questionnaires at pretest
(immediately prior to the prenatal genetic testing evaluation) and at post-test (12 weeks
post-intervention). The post-test set of questionnaires was mailed to all of the participants
for completion and return to the researchers in the included postage-paid, pre-addressed
envelope. Thirty experimental-group participants and 28 control-group participants completed
both pretest and post-test questionnaires. The CONSORT flow diagram for this study is shown
in Figure 1.
2.5 | Statistical analysis Data in this study were analyzed using the SPSS (version 17.0 for
Windows, SPSS Inc., Chicago, IL, USA) statistical software package. Tests used to analyze
differences in baseline characteristics between the two groups included the Chi-square (χ2)
test for categorical variables and the t-test for continuous variables. Paired sample t-tests
were conducted before and after nursing counseling to measure whether there were any
statistically significant changes in outcome variables. All results with p < .05 were
considered statistically significant.
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