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CompletedNCT04961463Updated Jul 19, 2021

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

An interventional study of psychoeducation in Psychoeducation, Nursing Caries and Behcet Syndrome, sponsored by Ulucanlar Eye Training and Research Hospital. Completed. Open to participants aged 23 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-07-19.

Sponsored by Ulucanlar Eye Training and Research Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 4 years 8 months after the study started (first participant enrolled Sep 2016, registered Jun 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
23 Years to 55 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Psychoeducation
  • Nursing Caries
  • Behcet Syndrome

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03

In context

Behcet Syndrome

136 studies on the registry are indexed under Behcet Syndrome; 43 are open to participants now.

This study's enrollment of 70 is above the median of 50 across 70 interventional studies indexed under Behcet Syndrome.

Browse Behcet Syndrome studies →

Lead sponsor

Ulucanlar Eye Training and Research Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
23 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Hearing and speech impairment
  • A psychiatric diagnosis
  • Neurological involvement
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • 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

Interventions

  • Behavioralpsychoeducation
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 week before psychoeducation (pre-test), After the psychoeducation (posttest) and 1 month after posttest

  2. 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.

    Time frame: 1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest

  3. 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.

    Time frame: 1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest

  4. 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

    Time frame: 1 week before psychoeducation (pre-test),1 week after the last session of psychoeducation (posttest) and 1 month after posttest

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04961463
Lead sponsor
Ulucanlar Eye Training and Research Hospital
Responsible party
Nermin Erdogan (Principal Investigator, Ulucanlar Eye Training and Research Hospital) — Principal investigator
First posted
Jul 14, 2021
Start date
Sep 15, 2016
Primary completion
May 15, 2018
Completion
May 15, 2018
Last update
Jul 19, 2021

Study contacts

Nermin Erdoğan
principal investigator · Ulucanlar Eye Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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