NCT06243523

Brief 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. 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 29, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

January 24, 2024

Last Update Submit

April 26, 2024

Conditions

Keywords

Neuman Systems ModelPsychoeducationPsychological distressCoping with stressIntensive care unitStress management

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before action (beginning) and after action (two weeks after the beginning)

Secondary Outcomes (1)

  • Stress Coping Styles Scale

    Before action (beginning) and after action (two weeks after the beginning)

Study Arms (1)

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.

Behavioral: The stress management psychoeducation program based on Neuman's Systems Model

Interventions

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.

Action group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 31132688BACKGROUND
  • Neuman B. The Neuman systems model in research and practice. Nurs Sci Q. 1996 Summer;9(2):67-70. doi: 10.1177/089431849600900207.

    PMID: 8710312BACKGROUND
  • Fawcett 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.

    PMID: 11873373BACKGROUND
  • Neslihan 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.

    PMID: 19567724BACKGROUND
  • Abdul 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.

    PMID: 34254377BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Yeliz KARAÇAR

    Akdeniz University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 6, 2024

Study Start

January 17, 2024

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

April 29, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations