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Evaluation of the Psychoeducation Program Given to Behcet's Patients in the Context of the Roy Adaptation Model

Primary Purpose

Psychoeducation, Nursing Caries, Behcet Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
psychoeducation
Sponsored by
Ulucanlar Eye Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychoeducation

Eligibility Criteria

23 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Married or had a partner life,
  • Were 18 years old

Exclusion Criteria:

  • Hearing and speech impairment
  • A psychiatric diagnosis
  • Neurological involvement

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    İnterventions group

    Control group

    Arm Description

    İnterventions group:The 7-session psychoeducation program prepared on the basis of the Roy Adaptation Model was applied to the intervention group once a week for 90-120 minutes

    Except for the routine hospital controls, no intervention was made to the control group

    Outcomes

    Primary Outcome Measures

    Evaluation of change in disease compliance
    Adaptation to chronic ilness scale was used to assess disease compliance. The minimum score that can be obtained from the scale is 25 and the maximum score is 125. As the total scale score increases, disease compliance also increases.
    Evaluation of change in psychiatric symptoms
    Brief symptom inventory was used to assess Psychiatric symptoms The minimum score that can be obtained from the scale is 0 and the maximum score is 212. As the total scale score increases, the level of psychiatric symptoms also increases.
    Evaluation of change in dyadic adjustment
    Dyadic adjustment scale was used to assess dyadic adjustment The minimum score that can be obtained from the scale is 0 and the maximum score is 151. Higher total adjustment score indicates better marital adjustment.
    Evaluation of change in Self-esteem
    Rosenberg self-esteem scale was used to assess self-esteem. The minimum score that can be obtained from the scale is 0 and the maximum score is 6. As the total scale score decreases, self-esteem increases

    Secondary Outcome Measures

    Full Information

    First Posted
    June 11, 2021
    Last Updated
    July 13, 2021
    Sponsor
    Ulucanlar Eye Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04961463
    Brief Title
    Evaluation of the Psychoeducation Program Given to Behcet's Patients in the Context of the Roy Adaptation Model
    Official Title
    Evaluation of the Psychoeducation Program Given to Behcet's Patients in the Context of the Roy Adaptation Model
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    September 15, 2016 (Actual)
    Primary Completion Date
    May 15, 2018 (Actual)
    Study Completion Date
    May 15, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ulucanlar Eye Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The physical, social and psychological effects of Behcet's disease necessitate the patient's adaptation in many areas. This study was conducted to examine the effect of psychoeducation given to Behcet's patients in the context of the Roy Adaptation Model on illness adjustment, dyadic adjustment, self-esteem, and psychiatric symptoms. The study is a control group quasi-experimental study with a pre-test, post-test and follow-up design. The study was conducted with 70 Behcet's patients including 35 interventions and 35 controls. The data of the study were collected using the "Patient Information Form", " Adaptation to Chronic Illness Scale", "Dyadic Adjustment Scale", "Rosenberg Self-Esteem Scale" and "Brief Symptom Inventory" in pre-test, post-test and follow-up measurements. A 7-session psychoeducation program was applied to the intervention group.
    Detailed Description
    The research was carried out by using quantitative research methods, quasi-experimental (pre-test, post-test, follow-up, control group) research method.The study was conducted with patients followed-up in eye, dermatology and rheumatology clinics of 6 state-owned hospitals in Ankara, Turkey. The sample size of the study was calculated with the PASS (Power Analysis and Sample Size) statistical package program. It was calculated that our study could be performed with 5% error and 90% power with 35 interventions and 35 control groups, with 70 patients in total. Thus, the research was completed with 70 patients, 35 interventions and 35 control groups.The 7-session psychoeducation program prepared on the basis of the Roy Adaptation Model was applied to the intervention group once a week for 90-120 minutes. Psychoeducation was conducted in 3 groups of 10-12 people, and make-up sessions were held for those who did not attend two consecutive psychoeducation sessions or did not attend two sessions in total. The contents of the psychoeducation sessions were created by the researcher, based on the Roy Adaptation Model, by examining the relevant literature. After the ethics committee report with the permission number GO16 / 229-21 was obtained from the Non-Interventional Clinical Research Ethics Committee of Hacettepe University, the application permission was obtained from the hospitals where the study will be conducted in order to be able to apply the study. Before starting the intervention, the patients were informed about the purpose and scope of the study, and written informed consent was obtained from the patients who agreed to participate in the study. For the control group, after the necessary information was given to the patients, their written informed consent was obtained.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychoeducation, Nursing Caries, Behcet Syndrome

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study is a control group quasi-experimental study with a pre-test, post-test and follow-up design
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    İnterventions group
    Arm Type
    Experimental
    Arm Description
    İnterventions group:The 7-session psychoeducation program prepared on the basis of the Roy Adaptation Model was applied to the intervention group once a week for 90-120 minutes
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Except for the routine hospital controls, no intervention was made to the control group
    Intervention Type
    Behavioral
    Intervention Name(s)
    psychoeducation
    Primary Outcome Measure Information:
    Title
    Evaluation of change in disease compliance
    Description
    Adaptation to chronic ilness scale was used to assess disease compliance. The minimum score that can be obtained from the scale is 25 and the maximum score is 125. As the total scale score increases, disease compliance also increases.
    Time Frame
    1 week before psychoeducation (pre-test), After the psychoeducation (posttest) and 1 month after posttest
    Title
    Evaluation of change in psychiatric symptoms
    Description
    Brief symptom inventory was used to assess Psychiatric symptoms The minimum score that can be obtained from the scale is 0 and the maximum score is 212. As the total scale score increases, the level of psychiatric symptoms also increases.
    Time Frame
    1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest
    Title
    Evaluation of change in dyadic adjustment
    Description
    Dyadic adjustment scale was used to assess dyadic adjustment The minimum score that can be obtained from the scale is 0 and the maximum score is 151. Higher total adjustment score indicates better marital adjustment.
    Time Frame
    1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest
    Title
    Evaluation of change in Self-esteem
    Description
    Rosenberg self-esteem scale was used to assess self-esteem. The minimum score that can be obtained from the scale is 0 and the maximum score is 6. As the total scale score decreases, self-esteem increases
    Time Frame
    1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    23 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Married or had a partner life, Were 18 years old Exclusion Criteria: Hearing and speech impairment A psychiatric diagnosis Neurological involvement
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nermin Erdoğan
    Organizational Affiliation
    Ulucanlar Eye Training and Research Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Evaluation of the Psychoeducation Program Given to Behcet's Patients in the Context of the Roy Adaptation Model

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