Clinical trial NCT04961463: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psychoeducation
Nursing Caries
Behcet Syndrome
Lead sponsor: Ulucanlar Eye Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 70
Sex: ALL
Minimum age (years): 23
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a control group quasi-experimental study with a pre-test, post-test and follow-up design
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Evaluation of change in disease compliance
timeFrame: 1 week before psychoeducation (pre-test), After the psychoeducation (posttest) and 1 month after posttest
measure: Evaluation of change in psychiatric symptoms
timeFrame: 1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest
measure: Evaluation of change in dyadic adjustment
timeFrame: 1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest
measure: Evaluation of change in Self-esteem
timeFrame: 1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ulucanlar Eye Training and Research Hospital
name: Nermin Erdoğan
role: PRINCIPAL_INVESTIGATOR
References: