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
About this trial
This is an interventional supportive care trial for Psychoeducation
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
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
NCT ID
NCT04961463
First Posted
June 11, 2021
Last Updated
July 13, 2021
Sponsor
Ulucanlar Eye Training and Research Hospital
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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