- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05118438
Development of a Health Promotion Nursing Intervention for Post-traumatic Stress Women Based on Swanson's Theory of Caring
Objectives: We aimed to (1) develop a caring program for health promotion among women who experienced trauma and (2) evaluate its effect on post-traumatic stress, depression, health-promoting behaviors, and self-esteem.
Methods: We conducted a quasi-experimental study using a group pre-test/post-test design. Data were collected from 14 women recruited from a self-sufficiency support center for sexually exploited women who experienced trauma, during December 2019-May 2020. Participants were assessed at pre-test, post-test, and at a one-month follow-up. We analyzed changes in outcome variables over time using repeated-measures analysis of variance and paired t-tests.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of
- Yonsei University Health System, Severance Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- women aged over 18 years who had experienced a traumatic event, and
- a PTS score of 64 or lower on the PTSD checklist for DSM-5 (PCL-5) developed by Weathers et al. (1993), revised by Weathers et al. (2013), and translated into Korean by Kim et al. (2017).
Exclusion Criteria:
- presence of psychiatric conditions with hallucinations and delusions, and
- diagnosis of an intellectual disability that would make understanding the intervention procedure difficult. Although a standard cut-off was not present in the PCL-5, women who exceeded 80% (64 points) of the total score were excluded to rule out high-risk women with severe trauma.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Nursing intervention
The recruited participants were clients of a self-sufficiency support center for sexually exploited women located in South Korea, recruited through snowball sampling after obtaining permission from the director of the support center.
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A one-on-one program was conducted over six sessions, with each session ranging from 60 to 120 minutes.
The caring program for health promotion included the following concepts: understanding the self; sharing traumatic events and negative emotions; re-framing the meaning of traumatic events; identifying thoughts and physical and emotional responses; developing health-promoting activities; and maintaining a positive attitude during the process of change .
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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post-traumatic stress
Time Frame: one month after the intervention
|
PTS was measured using the PCL-5, which was developed by Weathers et al. (1993), revised by Weathers et al. (2013) as per the revised PTSD definition in the DSM-5, and translated into Korean by Kim et al. (2017).
The Korean version of the PCL for the DSM-5 (PCL-5-K) contains 20 items, and each scored from 0 (not at all) to 4 (extremely).
The score depended on the severity of the symptom caused by stress related to traumatic events during the past month.
Possible scores ranged from 0 to 80, with a score of 37 or above indicating a PTSD diagnosis, and higher scores suggesting severe PTSD symptoms (Kim et al., 2017).
Cronbach's alpha coefficient for the PCL-5-K was .97
among Korean veterans of the Vietnam War (Kim et al., 2017) and .89 in the current study.
|
one month after the intervention
|
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depression
Time Frame: one month after the intervention
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Depression was assessed using the Center for Epidemiologic Studies Depression Scale (CES-D), developed by Radloff (1977), and translated into Korean by Chon and Rhee (1992).
The Korean version of the CES-D contains 20 items rated on a 4-point Likert scale (0 = rarely or never; to 3 = all the time), according to how respondents felt during the past week.
Possible scores ranged from 0 to 60, with a score of 16 or above indicating depressive symptoms, and higher scores indicating higher levels of depression (Radloff, 1977).
Cronbach's alpha coefficient for the Korean CES-D was .89
among Korean adults (Chon & Rhee, 1992) and .78 in our study.
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one month after the intervention
|
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health-promoting behaviors
Time Frame: one month after the intervention
|
Health-promoting behaviors were measured using the Health Promoting Lifestyle Profile-II (HPLP-II), developed by Walker et al. (1995) and translated into Korean by Yun and Kim (1999).
The Korean version of the HPLP-II comprises 52 items under six subscales: health responsibility (scores ranging from 9-36), physical activity (scores ranging from 8-32), nutrition (scores ranging from 9-36), spiritual growth (scores ranging from 9-36), interpersonal relations (scores ranging from 9-36), and stress management (scores ranging from 8-32).
It was rated on a 4-point Likert scale (1=never, 2=sometimes, 3=often, 4=routinely).
Possible scores ranged from 52 to 208, with higher scores indicating higher levels of health-promoting behaviors.
Cronbach's alpha coefficients were .78,
.87,
.69,
.77,
.81,
and .73 for health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management, respectively.
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one month after the intervention
|
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self-esteem
Time Frame: one month after the intervention
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Self-esteem was assessed using the Rosenberg Self Esteem Scale (RSES), developed by Rosenberg (1965), and translated into Korean by Bae et al. (2014).
The Korean version of the RSES (K-RSES) comprises ten items rated on a 4-point Likert scale, ranging from strongly agree to strongly disagree.
Possible scores ranged from 10 to 40, with higher scores indicating higher self-esteem.
Cronbach's alpha coefficient for the K-RSES was .90
among Korean adults (Bae et al., 2014) and .90 in our study.
|
one month after the intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Go-Un Kim, College of Nursing and Mo-Im Kim Nursing Research Institute, Yonsei University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Y-2019-0153
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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