Psychological DistressNCT06243523
The Effect of Psychoeducation Based on NSM on the Psychological Distress and Coping of the Spouses of Patients in ICU
A study testing The stress management psychoeducation program based on Neuman's Systems Model in people with Psychological Distress and Stress, Psychological, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The aim of action research this study is to examine the effect of psychoeducation based on Neuman's Systems Model on psychological distress and coping with the stress of spouses of patients in the intensive care unit. The questions of this research are listed below. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Stress, Psychological
- What is being tested?
- The stress management psychoeducation program based on Neuman's Systems Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2024to 1 Mar 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being the spouse of an individual with a critical illness and intubated who had an unplanned admission to the ICU for 48-72 hours or longer
- Being over 18 years of age
- Speaking Turkish
- --Not having hearing, visual, physical, or mental disabilities
- Agreeing to participate in the research verbally and in writing
Who cannot join
- Having a psychiatric illness or cognitive disorder,
- Having sensory loss related to vision, hearing, and speech,
- Being involved in another research that uses a similar method or that may affect the results of the study,
- Being included in any psychosocial support program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Psychoeducation Based on Neuman's Systems Model on the Psychological Distress and Coping With Stress of the Spouses of Patients in Intensive Care Unit
The aim of action research this study is to examine the effect of psychoeducation based on Neuman's Systems Model on psychological distress and coping with the stress of spouses of patients in the intensive care unit. The questions of this research are listed below.
What can be done to reduce the psychological distress of spouses of patients in the intensive care unit? What can be done to increase the active coping with the stress of spouses of patients in the intensive care unit? How to structure a stress management psychoeducational program based on Neuman's Systems Theory for spouses of patients in the intensive care unit? Does a stress management psychoeducation program based on Neuman's Systems Theory reduce the psychological distress of spouses of patients in the intensive care unit? Does a stress management psychoeducational program based on Neuman's Systems Theory increase active coping with the stress of spouses of patients in intensive care?
Read the detailed description
This study is mixed methods research that combines both exploratory mixed and nested action research phases of a multi-phase mixed design. In the first phase; It is planned to develop a stress management psychoeducation program based on Neuman's Systems Model based on the literature. In the second phase; It is planned to conduct technical action research based on the radical structuralist paradigm, one of the types of action research.
The study will be conducted with spouses of patients hospitalized in the Adult Intensive Care Unit of a State Hospital between January and March 2024.
It was planned to use the criterion sampling method, one of the purposeful sampling methods, in determining the sample of the research. The psychoeducation program will be implemented in six sessions with individual interviews lasting approximately 45-60 minutes, three times a week for the spouses of patients in intensive care. The first session includes the meeting and introduction of the psychoeducation program. The second session includes the adaptation process to the intensive care unit. The third, fourth and fifth sessions include methods of coping with stress. The sixth session includes evaluation and termination of the psychoeducational program.
Quantitative data of the research will be collected with the pre-action and post-action Psychological Distress Scale and the Stress Coping Styles Scale. Qualitative data of the research will be collected through semi-structured individual in-depth interviews conducted after the action. Quantitative data will be analyzed with the SPSS 25.0 package program. Continuous variables will be given as mean ± standard deviation and categorical variables will be given as number and percentage. Since non-parametric test assumptions are met in comparing the differences between psychological distress and styles of coping with stress (n<30), it will be analyzed with the Wilcoxon test. P <0.05 will be considered statistically significant. Analysis of qualitative data will be done with content analysis in Nvivo 11 qualitative data analysis program.
- Conditions
- Psychological Distress, Stress, Psychological
- Being tested
- The stress management psychoeducation program based on Neuman's Systems Model
- Keywords
- Neuman Systems Model, Psychoeducation, Psychological distress, Coping with stress, Intensive care unit, Stress management
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The stress management psychoeducation program based on Neuman's Systems ModelBehavioural
The stress management psychoeducation program will be implemented in six sessions with individual interviews lasting approximately 45-60 minutes, three times a week for the spouses of patients in intensive care. The first session includes the meeting and introduction of the psychoeducation program. The second session includes the adaptation process to the intensive care unit. The third, fourth and fifth sessions include methods of coping with stress. The sixth session includes evaluation and termination of the psychoeducational program. Quantitative data of the research will be collected with the pre-action and post-action Psychological Distress Scale and the Stress Coping Styles Scale. Qualitative data of the research will be collected through semi-structured individual in-depth interviews conducted after the action.
| Study group | Role | What they receive |
|---|---|---|
| Action group | Other | The action intervention of this research is the implementation of a stress management psychoeducation program based on Neuman's Systems Model for the spouses of patients hospitalized in the intensive care unit. Receives: Behavioral: The stress management psychoeducation program based on Neuman's Systems Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Kessler Psychological Distress Scale
Average score of the Kessler Psychological Distress Scale: The lowest score from the scale can be 10 and the highest score can be 50. Higher scores indicate more mental distress. Psychological distress levels according to the total score obtained from this scale; 10-19 points are interpreted as possible good, 20-24 points as possible mild mental disorder, 25-29 points as possible moderate mental disorder, and 30-50 points as possible severe mental disorder.
Measured: Before action (beginning) and after action (two weeks after the beginning)
Secondary outcomes (1)
Stress Coping Styles Scale
Average score of the Stress Coping Styles Scale: The scores obtained from the items belonging to each sub-dimension in the scale are added separately and divided by the total number of items belonging to that sub-dimension to obtain the average score for each sub-dimension. Scale Self-Confident Approach (7 items), Optimistic Approach (5 items), Helpless Approach (8 items); It consists of Submissive Approach (6 items) and Social Support Seeking (4 items) subscales.
Self-confident approach, optimistic approach and social support seeking approach are active/effective coping methods aimed at solving the problem. Helpless approach and submissive approach are passive/ineffective ways of coping with emotions. A higher score indicates that that sub-dimension is used more.
Measured: Before action (beginning) and after action (two weeks after the beginning)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start17 Jan 2024
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is mixed methods research that combines both exploratory mixed and nested action research phases of a multi-phase mixed design. In the first phase; It is planned to develop a stress management psychoeducation program based on Neuman's Systems Model based on the literature. In the second phase; It is planned to conduct technical action research based on the radical structuralist paradigm, one of the types of action research. It was planned to use the criterion sampling method, one of the purposeful sampling methods, in determining the sample of the research. The psychoeducation program will be implemented in six sessions with individual interviews lasting approximately 45-60 minutes, three times a week for the spouses of patients in intensive care.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Karaçar, Akdeniz University
- Investigators
- Yeliz KARAÇAR, Study chair, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243523
- Sponsor's protocol ID
- KAEK-172
- Status last verified
- Apr 2024
- First submitted
- 24 Jan 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruckholdt M, Tofler GH, Randall S, Buckley T. Coping by family members of critically ill hospitalised patients: An integrative review. Int J Nurs Stud. 2019 Sep;97:40-54. doi: 10.1016/j.ijnurstu.2019.04.016. Epub 2019 May 4.
PubMed 31132688Neuman B. The Neuman systems model in research and practice. Nurs Sci Q. 1996 Summer;9(2):67-70. doi: 10.1177/089431849600900207.
PubMed 8710312Fawcett J, Gigliotti E. Using conceptual models of nursing to guide nursing research: the case of the Neuman systems model. Nurs Sci Q. 2001 Oct;14(4):339-45. doi: 10.1177/089431840101400411.
PubMed 11873373Neslihan Partlak Gunusen, Ustun B, Gigliotti E. Conceptualization of burnout from the perspective of the Neuman systems model. Nurs Sci Q. 2009 Jul;22(3):200-4. doi: 10.1177/0894318409338685.
PubMed 19567724Abdul Halain A, Tang LY, Chong MC, Ibrahim NA, Abdullah KL. Psychological distress among the family members of Intensive Care Unit (ICU) patients: A scoping review. J Clin Nurs. 2022 Mar;31(5-6):497-507. doi: 10.1111/jocn.15962. Epub 2021 Jul 12.
PubMed 34254377
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psychoeducation Based on Neuman's Systems Model on the Psychological Distress and Coping With Stress of the Spouses of Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06243523
- Acronym / sponsor ID
- KAEK-172
- Conditions
- Psychological Distress, Stress, Psychological
- Keywords
- Neuman Systems Model, Psychoeducation, Psychological distress, Coping with stress, Intensive care unit, Stress management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 6 Feb 2024 (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.
The aim of action research this study is to examine the effect of psychoeducation based on Neuman's Systems Model on psychological distress and coping with the stress of spouses of patients in the intensive care unit. The questions of this research are listed below.
What can be done to reduce the psychological distress of spouses of patients in the intensive care unit? What can be done to increase the active coping with the stress of spouses of patients in the intensive care unit? How to structure a stress management psychoeducational program based on Neuman's Systems Theory for spouses of patients in the intensive care unit? Does a stress management psychoeducation program based on Neuman's Systems Theory reduce the psychological distress of spouses of patients in the intensive care unit? Does a stress management psychoeducational program based on Neuman's Systems Theory increase active coping with the stress of spouses of patients in intensive care?
Detailed description
This study is mixed methods research that combines both exploratory mixed and nested action research phases of a multi-phase mixed design. In the first phase; It is planned to develop a stress management psychoeducation program based on Neuman's Systems Model based on the literature. In the second phase; It is planned to conduct technical action research based on the radical structuralist paradigm, one of the types of action research.
The study will be conducted with spouses of patients hospitalized in the Adult Intensive Care Unit of a State Hospital between January and March 2024.
It was planned to use the criterion sampling method, one of the purposeful sampling methods, in determining the sample of the research. The psychoeducation program will be implemented in six sessions with individual interviews lasting approximately 45-60 minutes, three times a week for the spouses of patients in intensive care. The first session includes the meeting and introduction of the psychoeducation program. The second session includes the adaptation process to the intensive care unit. The third, fourth and fifth sessions include methods of coping with stress. The sixth session includes evaluation and termination of the psychoeducational program.
Quantitative data of the research will be collected with the pre-action and post-action Psychological Distress Scale and the Stress Coping Styles Scale. Qualitative data of the research will be collected through semi-structured individual in-depth interviews conducted after the action. Quantitative data will be analyzed with the SPSS 25.0 package program. Continuous variables will be given as mean ± standard deviation and categorical variables will be given as number and percentage. Since non-parametric test assumptions are met in comparing the differences between psychological distress and styles of coping with stress (n<30), it will be analyzed with the Wilcoxon test. P <0.05 will be considered statistically significant. Analysis of qualitative data will be done with content analysis in Nvivo 11 qualitative data analysis program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is mixed methods research that combines both exploratory mixed and nested action research phases of a multi-phase mixed design. In the first phase; It is planned to develop a stress management psychoeducation program based on Neuman's Systems Model based on the literature. In the second phase; It is planned to conduct technical action research based on the radical structuralist paradigm, one of the types of action research. It was planned to use the criterion sampling method, one of the purposeful sampling methods, in determining the sample of the research. The psychoeducation program will be implemented in six sessions with individual interviews lasting approximately 45-60 minutes, three times a week for the spouses of patients in intensive care.
| Arm | Type | Receives |
|---|---|---|
| Action group | Other | Behavioral: The stress management psychoeducation program based on Neuman's Systems ModelThe action intervention of this research is the implementation of a stress management psychoeducation program based on Neuman's Systems Model for the spouses of patients hospitalized in the intensive care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being the spouse of an individual with a critical illness and intubated who had an unplanned admission to the ICU for 48-72 hours or longer
- Being over 18 years of age
- Speaking Turkish
- --Not having hearing, visual, physical, or mental disabilities
- Agreeing to participate in the research verbally and in writing
Key exclusion criteria (4 listed)
- Having a psychiatric illness or cognitive disorder,
- Having sensory loss related to vision, hearing, and speech,
- Being involved in another research that uses a similar method or that may affect the results of the study,
- Being included in any psychosocial support program.
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 |
|---|---|---|
| The stress management psychoeducation program based on Neuman's Systems ModelThe stress management psychoeducation program will be implemented in six sessions with individual interviews lasting approximately 45-60 minutes, three times a week for the spouses of patients in intensive care. The first session includes the meeting and introduction of the psychoeducation program. The second session includes the adaptation process to the intensive care unit. The third, fourth and fifth sessions include methods of coping with stress. The sixth session includes evaluation and termination of the psychoeducational program. Quantitative data of the research will be collected with the pre-action and post-action Psychological Distress Scale and the Stress Coping Styles Scale. Qualitative data of the research will be collected through semi-structured individual in-depth interviews conducted after the action. | Behavioural | Action group |
Primary outcome
The Kessler Psychological Distress Scale
Time frame: Before action (beginning) and after action (two weeks after the beginning)
Average score of the Kessler Psychological Distress Scale: The lowest score from the scale can be 10 and the highest score can be 50. Higher scores indicate more mental distress. Psychological distress levels according to the total score obtained from this scale; 10-19 points are interpreted as possible good, 20-24 points as possible mild mental disorder, 25-29 points as possible moderate mental disorder, and 30-50 points as possible severe mental disorder.
1 secondary outcome
Stress Coping Styles Scale
Time frame: Before action (beginning) and after action (two weeks after the beginning)
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 29 Apr 2024.
- Background: PubMed 31132688Ruckholdt M, Tofler GH, Randall S, Buckley T. Coping by family members of critically ill hospitalised patients: An integrative review. Int J Nurs Stud. 2019 Sep;97:40-54. doi: 10.1016/j.ijnurstu.2019.04.016. Epub 2019 May 4.
- Background: PubMed 8710312Neuman B. The Neuman systems model in research and practice. Nurs Sci Q. 1996 Summer;9(2):67-70. doi: 10.1177/089431849600900207.
- Background: PubMed 11873373Fawcett J, Gigliotti E. Using conceptual models of nursing to guide nursing research: the case of the Neuman systems model. Nurs Sci Q. 2001 Oct;14(4):339-45. doi: 10.1177/089431840101400411.
- Background: PubMed 19567724Neslihan Partlak Gunusen, Ustun B, Gigliotti E. Conceptualization of burnout from the perspective of the Neuman systems model. Nurs Sci Q. 2009 Jul;22(3):200-4. doi: 10.1177/0894318409338685.
- Background: PubMed 34254377Abdul Halain A, Tang LY, Chong MC, Ibrahim NA, Abdullah KL. Psychological distress among the family members of Intensive Care Unit (ICU) patients: A scoping review. J Clin Nurs. 2022 Mar;31(5-6):497-507. doi: 10.1111/jocn.15962. Epub 2021 Jul 12.
- Individual participant dataSharing planned: No
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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.
Yeliz KARAÇAR study chair
Akdeniz 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 The stress management psychoeducation program based on Neuman's Systems Model in people with Psychological Distress and Stress, Psychological, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 29 Apr 2024. 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 Turkey (Türkiye). 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?
The Kessler Psychological Distress Scale (time frame: Before action (beginning) and after action (two weeks after the beginning)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06243523, which also lists 5 linked publications.
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 29 Apr 2024.