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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05971797
Other study ID # 2020-9
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2021

Study information

Verified date August 2023
Source Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study was evaluation of the effectiveness of REBT on the emotional state of orthopedic patients with comorbidities before and after arthroplasty.


Description:

The studies assessed depression or anxiety in orthopedic patients by using Spielberger State-Trait Anxiety Inventory (STAI) and Hospital Anxiety and Depression Scale (HADS) before and after athroplasty. The comorbid background studied. The orthopedic patients with comorbidities were divided into several groups: arterial hypertension, chronic pyelonephritis , varicose veins, cardiovascular disease and atherosclerosis, diabetes mellitus, infection diseases, gastrointestinal diseases, obesity, neurological disorder, cerebrovascular accident, iron deficiency anemia, chronic bronchitis, hyperthyroidism, cardiac arrhythmia, other diseases. Patients with high levels of anxiety and depression underwent Rational Emotive Behavior Therapy before surgery. Patients without comorbidities and patients with comorbidities but without exposure considered as a control.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date December 31, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients enrolled for the primary knee or hip arthroplasty (M15.0, M16, M17) before operation. Exclusion Criteria: - Other types of psychiatric pathology - Reluctance to undergo psychological correction - Failure to pass pre-test - Ongoing follow-up with a psychologist or psychiatrist

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
REBT
During REBT in patients with osteoarthritis and concomitant diseases with diagnosed depression or anxiety before arthroplasty the patients learn how to manage their irrational or unhealthy emotions, thoughts, and behaviors.

Locations

Country Name City State
Russian Federation Federal Center for Traumatology, Orthopedics and Endoprosthetics Cheboksary Chuvashia

Sponsors (2)

Lead Sponsor Collaborator
Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty Chuvash State University named after I.N. Ulyanov

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary STAI Each subscale uses a 4-point Likert scale with a range from 1 ("not at all" for S- or "almost never" for T-Anxiety) to 4 ("very much so" for S- and "almost always" for T-Anxiety). Reverse scoring is used for anxiety-absent items (e.g., "I feel calm" or "I am happy"), and therefore, a higher score indicates more severe anxiety with a potential range from 20 to 80 for each subscale. According to the developer scores of 20-39, 40-59, and 60-80 indicate low, moderate, and high anxiety, respectively. Normative values are available in the manual. 2 days after surgery
Primary HADS The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). with a range from 0 ("not at all") to 3 ("most of the time"). Reverse scoring is used for items with positive wording (e.g., "I still enjoy the things I used to enjoy"). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). A score of 8-10 should be classified as a mild disorder, 11-15 as a moderate disorder, and 16 or more as a severe disorder. 2 days after surgery
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