Women Who Have Experienced TraumaNCT05118438
Development of a Health Promotion Nursing Intervention for Post-traumatic Stress Women Based on Swanson's Theory of Caring
A study testing Health Promotion Nursing Intervention in people with Women Who Have Experienced Trauma, run by Yonsei University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women Who Have Experienced Trauma
- What is being tested?
- Health Promotion Nursing Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Dec 2019to 30 May 2020
- 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 20 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
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.
- Conditions
- Women Who Have Experienced Trauma
- Being tested
- Health Promotion Nursing Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Promotion Nursing InterventionOther
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 .
| Study group | Role | What they receive |
|---|---|---|
| Nursing intervention | Experimental | 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. Receives: Other: Health Promotion Nursing Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-traumatic stress
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.
Measured: one month after the intervention
depression
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.
Measured: one month after the intervention
health-promoting behaviors
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.
Measured: one month after the intervention
self-esteem
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.
Measured: one month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start2 Dec 2019
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women Who Have Experienced TraumaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Go-Un Kim, Principal investigator, College of Nursing and Mo-Im Kim Nursing Research Institute, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118438
- Sponsor's protocol ID
- Y-2019-0153
- Status last verified
- Nov 2021
- First submitted
- 29 Oct 2021
- Last updated
- 12 Nov 2021
- 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 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Health Promotion Nursing Intervention for Post-traumatic Stress Women Based on Swanson's Theory of Caring
- ClinicalTrials.gov ID
- NCT05118438
- Acronym / sponsor ID
- Y-2019-0153
- Conditions
- Women Who Have Experienced Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 12 Nov 2021 (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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nursing intervention | Experimental | Other: Health Promotion Nursing InterventionThe 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. |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Health Promotion Nursing InterventionA 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 . | Other | Nursing intervention |
Primary outcome
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.
depression
Time frame: one month after the intervention
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.
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.
self-esteem
Time frame: one month after the intervention
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.
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 12 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Women Who Have Experienced Trauma
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BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
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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.
Go-Un Kim principal investigator
College of Nursing and Mo-Im Kim Nursing Research Institute, Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Promotion Nursing Intervention in people with Women Who Have Experienced Trauma, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 2 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 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
post-traumatic stress (time frame: one month after the intervention). 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 12 Nov 2021.