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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015435
Receipt No. R000017949
Scientific Title The impact of caregivers' trait-anxiety and patient religiosity on anxiety before fast-track total knee arthroplasty.
Date of disclosure of the study information 2014/10/14
Last modified on 2016/02/23

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Basic information
Public title The impact of caregivers' trait-anxiety and patient religiosity on anxiety before fast-track total knee arthroplasty.
Acronym Anxiety before fast-track operations: the role of patient religiosity and caregivers' trait-anxiety
Scientific Title The impact of caregivers' trait-anxiety and patient religiosity on anxiety before fast-track total knee arthroplasty.
Scientific Title:Acronym Anxiety before fast-track operations: the role of patient religiosity and caregivers' trait-anxiety
Region
Europe

Condition
Condition Anxiety
Classification by specialty
Oto-rhino-laryngology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The first purpose of this study was to determine the influence of religious attitude and religiousness on the preoperative anxiety of Polish patients undergoing fast-track total knee and hip arthroplasty. The second purpose was to examine the relationship between preoperative patient state anxiety and trait anxiety of patient's caregiver in both women and men
Basic objectives2 Others
Basic objectives -Others we hypothesized that caregiver's trait anxiety would result in increase in preoperative state anxiety in patient
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome is anxiety assessed with the Spielberger State-Trait Anxiety Inventory state (STAI-S) and trait (STAI-T) scores and religiosity
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 No intervention
Interventions/Control_2
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
18 years-old <=
Age-upper limit
84 years-old >
Gender Male and Female
Key inclusion criteria Kellgren and Lawrence radiographic stage IV primary osteoarthrosis of the knee
Key exclusion criteria neurologic or psychiatric disease, or alcohol abuse.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Zietek
Organization Pomeranian Medical University
Division name Pomeranian Medical University
Zip code
Address ul. Unii Lubelskiej 1, Szczecin, Poland
TEL +48914253238
Email 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
Email paulz@wp.pl

Sponsor
Institute Zietek
Institute
Department

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
Email

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
2014 Year 10 Month 14 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 Completed
Date of protocol fixation
2014 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 14 Day
Last follow-up date
2015 Year 04 Month 30 Day
Date of closure to data entry
2015 Year 04 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 10 Month 14 Day
Last modified on
2016 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017949

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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