Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04961463 |
Other study ID # |
Ulucanlar ETRH |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 15, 2016 |
Est. completion date |
May 15, 2018 |
Study information
Verified date |
July 2021 |
Source |
Ulucanlar Eye Training and Research Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.