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.

Study Overview

• Status: Completed
• Conditions: Behcet Syndrome; Nursing Caries; Psychoeducation
• Intervention / Treatment: Behavioral: psychoeducation

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: İnterventions group; 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	Behavioral: psychoeducation
No Intervention: Control group; Except for the routine hospital controls, no intervention was made to the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week before psychoeducation (pre-test), After the psychoeducation (posttest) and 1 month after posttest
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.	1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest
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.	1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest
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	1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest

Collaborators and Investigators

• Sponsor: Ulucanlar Eye Training and Research Hospital
• Investigators: Principal Investigator: Nermin Erdoğan, Ulucanlar Eye Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2016
• Primary Completion (Actual): May 15, 2018
• Study Completion (Actual): May 15, 2018

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Eye Diseases; Genetic Diseases, Inborn; Stomatognathic Diseases; Mouth Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Vasculitis; Hereditary Autoinflammatory Diseases; Skin Diseases, Genetic; Skin Diseases, Vascular; Behcet Syndrome
• Other Study ID Numbers: Ulucanlar ETRH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No