UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012621 |
|---|---|
| Receipt number | R000014760 |
| Scientific Title | Effect of presence of therapists during preoperative interview on preoperative anxiety in outpatient and short-stay total knee arthroplasty patients: a randomized trial |
| Date of disclosure of the study information | 2013/12/19 |
| Last modified on | 2013/12/19 03:50:21 |
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Basic information
Public title
Effect of presence of therapists during preoperative interview on preoperative anxiety in outpatient and short-stay total knee arthroplasty patients: a randomized trial
Acronym
Therapists and anxiety in knee arthroplasty patients.
Scientific Title
Effect of presence of therapists during preoperative interview on preoperative anxiety in outpatient and short-stay total knee arthroplasty patients: a randomized trial
Scientific Title:Acronym
Therapists and anxiety in knee arthroplasty patients.
Region
| Europe |
Condition
Condition
Osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of presence of therapists during preoperative interview on preoperative anxiety in patients undergoing total knee arthroplasty
Basic objectives2
Others
Basic objectives -Others
Effectiveness of preoperative interview and its influence on knee function and pain
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the Spielberger State-Trait Anxiety Inventory state (STAI-S) and trait (STAI-T) scores. It is commonly used as a measure of anxiety. The subject is asked to complete a STAI
Key secondary outcomes
Secondary outcomes are knee pain and function assessed by the KOOS questionnaire and visual analogue scale.
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Participants of the intervention group have a preoperative interview with a surgeon and therapist.
Interventions/Control_2
Participants of the control group have a preoperative interview only with a surgeon.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
radiographic stage IV primary osteoarthrosis; patients undergoing TKA in the orthopedic department of Pomeranian Medical University; adults; patients operated by the same surgeon
Key exclusion criteria
Patients were excluded if they were unable to complete the protocol or had rheumatoid arthritis, systemic or metabolic disorders, an American Society of Anesthesiologists (ASA) score of 3, previous major surgery on the affected joint, neurologic or psychiatric disease, or alcohol abuse.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Zietek |
Organization
Pomeranian Medical University in Szczecin
Division name
Pomeranian Medical University in Szczecin
Zip code
Address
ul. Unii Lubelskiej 1, Szczecin, Poland
TEL
+48914253238
paulz@wp.pl
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Zietek |
Organization
Pomeranian Medical University in Szczecin
Division name
Pomeranian Medical University in Szczecin
Zip code
Address
ul. Unii Lubelskiej 1, Szczecin, Poland
TEL
+48914253238
Homepage URL
paulz@wp.pl
Sponsor or person
Institute
Zietek
Institute
Department
Personal name
Funding Source
Organization
own
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 19 | Day |
Last modified on
| 2013 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014760
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| Registered date | File name |
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