Nursing Counseling on Stress and Depression for Women With Recurrent Miscarriage

NCT04361747 | Completed

• 1 other identifier: MOST 104-2314-B-006-048-MY3
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Care in Women With History of Recurrent Miscarriage

Keywords

recurrent miscarriage; nursing counseling; perceived stress; depression

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  12 weeks

Study Arms (2)

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.

Behavioral: nursing counseling

control group

NO INTERVENTION

control group participants received regular care only

Interventions

nursing counseling BEHAVIORAL

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.

nursing counseling intervention

Eligibility Criteria

• Age: 24 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

MeSH Terms

Conditions

Abortion, Habitual; Depression

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavioral Symptoms; Behavior

Study Officials

• Pao-Lin Kuo, MD

  College of Medicine, National Cheng-Kung University, Tainan, Taiwan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 24, 2020
• Study Start: October 1, 2016
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share