NCT Number: NCT04961463
Evaluation of the Psychoeducation Program Given to Behcet's Patients in the Context of the Roy Adaptation Model
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.
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Notify MeKey information
Conditions
Age range
23 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Married or had a partner life,
- Were 18 years old
Exclusion criteria
- Hearing and speech impairment
- A psychiatric diagnosis
- Neurological involvement
Treatment and study plan
Primary outcomes
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Evaluation of change in disease compliance
Time frame: 1 week before psychoeducation (pre-test), After the psychoeducation (posttest) and 1 month after posttest
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.
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Evaluation of change in psychiatric symptoms
Time frame: 1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest
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.
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Evaluation of change in dyadic adjustment
Time frame: 1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest
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.
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Evaluation of change in Self-esteem
Time frame: 1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest
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
Sponsors and collaborators
Lead sponsor
Ulucanlar Eye Training and Research Hospital
Other
Registry information
Important dates
- Study start
- 2016
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Jul 14, 2021
- Registry last updated
- Jul 19, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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