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Clinical Trials/NCT04961463
NCT04961463CompletedNot Applicable

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

Ulucanlar Eye Training and Research Hospital0 sites70 target enrollmentStarted: September 15, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Primary Endpoint
Evaluation of change in disease compliance

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
23 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

İnterventions group

Experimental

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

Intervention: psychoeducation (Behavioral)

Control group

No Intervention

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

Outcomes

Primary Outcomes

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.

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.

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.

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ulucanlar Eye Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nermin Erdogan

Principal Investigator

Ulucanlar Eye Training and Research Hospital

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