The Influence of Rapid Recovery on Sleep Quality Following Total Knee Replacement Surgery

July 26, 2016 updated by: Liu Yang, Southwest Hospital, China
The purpose of this study is to evaluate the influence of rapid recovery on sleep quality following total knee replacement surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Southwest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Chinese

Description

Inclusion Criteria:

  1. Primary unilateral total knee artropasty;
  2. Patients with Knee osteoartritis or Rheumatoid arthritis;
  3. Able and willing to provide signed informed consent.

Exclusion Criteria:

  1. Simultaneously bilateral total knee artropasty or revision case;
  2. Surgical History of the knee joint;
  3. Knee joint cavity paracentesis in recent 3 months;
  4. Stiffness with knee;
  5. Blood coagulation disorders;
  6. History of deep venous thrombosis;
  7. Concomitant medical problems such as uncontrolled hypertention, severe cardiovascular disorder, chronic obstructive pulmonary disease, liver or renal failure
  8. allergic to NSAIDs, opioid analgesics, zolpidem
  9. sleep apnea, Parkinson disease, dementia, depression
  10. use of sedatives or hypnotics
  11. inability to comply with polysomnographic measurement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental group
rapid recovery
Behavioral: rapid recovery
rapid recovery
Controlled group
no rapid recovery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
WOMAC score
Time Frame: 1 mounth
1 mounth
GAD-7
Time Frame: 1 mounth
1 mounth
PSQI index
Time Frame: 1 mounth
1 mounth
Insomnia severity index
Time Frame: 1 mounth
1 mounth
polysomnographic measurement
Time Frame: 1 mounth
1 mounth
VAS
Time Frame: 1 mounth
1 mounth
Range of motion
Time Frame: 1 mounth
1 mounth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 23, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 27, 2016

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Southwest Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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