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Nursing Counseling on Stress and Depression for Women With Recurrent Miscarriage

Primary Purpose

Care in Women With History of Recurrent Miscarriage

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nursing counseling
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Care in Women With History of Recurrent Miscarriage focused on measuring recurrent miscarriage, nursing counseling, perceived stress, depression

Eligibility Criteria

24 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • (1) having experienced at least two consecutive miscarriages and (2) providing informed consent to participate.

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    nursing counseling intervention

    control group

    Arm Description

    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.

    control group participants received regular care only

    Outcomes

    Primary Outcome Measures

    Pittsburgh Sleep Quality Index (PSQI)
    Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989). A PSQI global score of > 5 was adopted to indicate poor sleep quality, which yields a diagnostic sensitivity of 98.7% and specificity of 84.4% for diagnosing sleep disturbances (Backhaus et al., 2002). The summed scores for the seven components form a global PSQI score (range = 0-21); higher scores indicate poorer sleep quality.
    Edinburgh Prenatal Depression Scale (EPDS)
    The severity of depressive symptoms in our study participants during the previous week was measured using the EPDS (Cox, Holden, & Sagovsky, 1987). The EPDS consists of 10 items on a 4-point scale from 0 (not at all) to 3 (yes, most of the time). Total scores range from 0 to 30. Higher scores indicate more depressive symptoms. EPDS can be used as a screening tool for depression in pregnant and postnatal women, and has been shown to have good reliability (Da Costa, Larouche, Dritsa, & Brender, 2000; Eberhard-Gran, Eskild, Tambs, Opjordsmoen, & Samuelsen, 2001; Evans, Heron, Francomb, Oke, & Golding, 2001). In Taiwan, the Chinese-language version of the EPDS has good internal consistency (Heh, 2001; Hsu & Chen, 2008; Ko et al., 2010; Su et al., 2007), concurrent validity of 0.79 with the Beck Depression Inventory (Heh, 2001), and a sensitivity of 83% and specificity of 89% (Su et al., 2007). The Cronbach's alpha value for our study using the EPDS was 0.90.
    Perceived Stress Scale (PSS)
    The PSS was designed to measure the degree to which a person appraises the situations in one's life as stressful. Items of the PSS were designed to express how unpredictable, uncontrollable, and overloaded respondents find their lives to be (Cohen, Kamarch, & Mermelstein, 1983). The 10 items on the scale are rated by the subject on a 4-point scale representing the frequency with which each item occurred. The greater the stress, the higher the scores. The Chinese version of the PSS has adequate internal consistency, test-retest reliability, and construct validity.
    Interpersonal Support Evaluation List (ISEL)
    Social support was examined using the ISEL Short Form (Cohen, Mermelstein, Kamarch, & Hoberman, 1985). This scale measures four types of social support: tangible, appraisal, self-esteem, and belonging. It consists of 16 items with a 4-point scale ranging from (0) definitely false, to (3) definitely true. The higher the score, the higher the level of perceived social support is. The Chinese version of the ISEL Short Form has adequate convergent validity (r = 0.55 with the Social Support Index), internal consistency (α = 0.81), and test-retest reliability (r = 0.77) (Chen et al., 1994). Cronbach's α in the present study was 0.90.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 20, 2020
    Last Updated
    April 22, 2020
    Sponsor
    National Cheng-Kung University Hospital
    Collaborators
    Ministry of Science and Technology, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04361747
    Brief Title
    Nursing Counseling on Stress and Depression for Women With Recurrent Miscarriage
    Official Title
    Effectiveness of Nursing Counseling on Stress and Depression for Women With Recurrent Miscarriage: A Randomized Controlled Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    January 31, 2018 (Actual)
    Study Completion Date
    January 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Cheng-Kung University Hospital
    Collaborators
    Ministry of Science and Technology, Taiwan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Care in Women With History of Recurrent Miscarriage
    Keywords
    recurrent miscarriage, nursing counseling, perceived stress, depression

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    Participant
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    nursing counseling intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    control group participants received regular care only
    Intervention Type
    Behavioral
    Intervention Name(s)
    nursing counseling
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pittsburgh Sleep Quality Index (PSQI)
    Description
    Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989). A PSQI global score of > 5 was adopted to indicate poor sleep quality, which yields a diagnostic sensitivity of 98.7% and specificity of 84.4% for diagnosing sleep disturbances (Backhaus et al., 2002). The summed scores for the seven components form a global PSQI score (range = 0-21); higher scores indicate poorer sleep quality.
    Time Frame
    12 weeks
    Title
    Edinburgh Prenatal Depression Scale (EPDS)
    Description
    The severity of depressive symptoms in our study participants during the previous week was measured using the EPDS (Cox, Holden, & Sagovsky, 1987). The EPDS consists of 10 items on a 4-point scale from 0 (not at all) to 3 (yes, most of the time). Total scores range from 0 to 30. Higher scores indicate more depressive symptoms. EPDS can be used as a screening tool for depression in pregnant and postnatal women, and has been shown to have good reliability (Da Costa, Larouche, Dritsa, & Brender, 2000; Eberhard-Gran, Eskild, Tambs, Opjordsmoen, & Samuelsen, 2001; Evans, Heron, Francomb, Oke, & Golding, 2001). In Taiwan, the Chinese-language version of the EPDS has good internal consistency (Heh, 2001; Hsu & Chen, 2008; Ko et al., 2010; Su et al., 2007), concurrent validity of 0.79 with the Beck Depression Inventory (Heh, 2001), and a sensitivity of 83% and specificity of 89% (Su et al., 2007). The Cronbach's alpha value for our study using the EPDS was 0.90.
    Time Frame
    12 weeks
    Title
    Perceived Stress Scale (PSS)
    Description
    The PSS was designed to measure the degree to which a person appraises the situations in one's life as stressful. Items of the PSS were designed to express how unpredictable, uncontrollable, and overloaded respondents find their lives to be (Cohen, Kamarch, & Mermelstein, 1983). The 10 items on the scale are rated by the subject on a 4-point scale representing the frequency with which each item occurred. The greater the stress, the higher the scores. The Chinese version of the PSS has adequate internal consistency, test-retest reliability, and construct validity.
    Time Frame
    12 weeks
    Title
    Interpersonal Support Evaluation List (ISEL)
    Description
    Social support was examined using the ISEL Short Form (Cohen, Mermelstein, Kamarch, & Hoberman, 1985). This scale measures four types of social support: tangible, appraisal, self-esteem, and belonging. It consists of 16 items with a 4-point scale ranging from (0) definitely false, to (3) definitely true. The higher the score, the higher the level of perceived social support is. The Chinese version of the ISEL Short Form has adequate convergent validity (r = 0.55 with the Social Support Index), internal consistency (α = 0.81), and test-retest reliability (r = 0.77) (Chen et al., 1994). Cronbach's α in the present study was 0.90.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    24 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (1) having experienced at least two consecutive miscarriages and (2) providing informed consent to participate. Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pao-Lin Kuo, MD
    Organizational Affiliation
    College of Medicine, National Cheng-Kung University, Tainan, Taiwan
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Nursing Counseling on Stress and Depression for Women With Recurrent Miscarriage

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