Care in Women With History of Recurrent MiscarriageNCT04361747
Nursing Counseling on Stress and Depression for Women With Recurrent Miscarriage
A study testing nursing counseling in people with Care in Women With History of Recurrent Miscarriage, run by National Cheng-Kung University Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 24 to 45 years, women only
- Conditions the study is for
- Care in Women With History of Recurrent Miscarriage
- What is being tested?
- nursing counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- (1) having experienced at least two consecutive miscarriages and (2) providing informed consent to participate.
Who cannot join
- -
About this study
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.
Read the 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.
- Being tested
- nursing counseling
- Keywords
- recurrent miscarriage, nursing counseling, perceived stress, depression
- Medical subject headings
- Abortion, Habitual, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nursing counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| nursing counseling intervention | Experimental | 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. Receives: Behavioral: nursing counseling |
| control group | No intervention | control group participants received regular care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Oct 2016
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Care in Women With History of Recurrent MiscarriageStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Chung-Hey Chen, National Cheng-Kung University Hospital
- Investigators
- Pao-Lin Kuo, MD, Study director, College of Medicine, National Cheng-Kung University, Tainan, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361747
- Sponsor's protocol ID
- MOST 104-2314-B-006-048-MY3
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nursing Counseling on Stress and Depression for Women With Recurrent Miscarriage: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04361747
- Acronym / sponsor ID
- MOST 104-2314-B-006-048-MY3
- Keywords
- recurrent miscarriage, nursing counseling, perceived stress, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| nursing counseling intervention | Experimental | Behavioral: nursing counselingThe 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 | No intervention | –control group participants received regular care only |
Who may qualify
- Ages
- 24 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (1) having experienced at least two consecutive miscarriages and (2) providing informed consent to participate.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nursing counselingThe counseling intervention was designed to facilitate self-awareness, reduce self-blame, clarify doubts, listen to patient concerns, promote forward thinking, and encourage life planning. | Behavioural | nursing counseling intervention |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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)
Time frame: 12 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pao-Lin Kuo, MD study director
College of Medicine, National Cheng-Kung University, Tainan, Taiwan
Questions about this trial
What is this clinical trial studying?
A study testing nursing counseling in people with Care in Women With History of Recurrent Miscarriage, run by National Cheng-Kung University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.