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

Sponsor
Ulucanlar Eye Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04961463
Collaborator
(none)
70
2
19.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: psychoeducation
N/A

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
Actual Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study is a control group quasi-experimental study with a pre-test, post-test and follow-up designThe study is a control group quasi-experimental study with a pre-test, post-test and follow-up design
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of the Psychoeducation Program Given to Behcet's Patients in the Context of the Roy Adaptation Model
Actual Study Start Date :
Sep 15, 2016
Actual Primary Completion Date :
May 15, 2018
Actual Study Completion Date :
May 15, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of change in disease compliance [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.

  2. Evaluation of change in psychiatric symptoms [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.

  3. Evaluation of change in dyadic adjustment [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.

  4. Evaluation of change in Self-esteem [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
23 Years to 55 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ulucanlar Eye Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nermin Erdogan, Principal Investigator, Ulucanlar Eye Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04961463
Other Study ID Numbers:
  • Ulucanlar ETRH
First Posted:
Jul 14, 2021
Last Update Posted:
Jul 19, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2021