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

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ClinicalTrials.gov Identifier: NCT02852460
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Liu Yang, Southwest Hospital, China

Brief Summary:
To evaluate the influence of rapid recovery on sleep quality following total hip replacement surgery

Condition or disease Intervention/treatment Phase
Arthroplasty Recovery of Function Sleep Quality Other: rapid recovery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : April 2016
Estimated Primary Completion Date : September 2016

Arm Intervention/treatment
Experimental: Experimental group
rapid recovery
Other: rapid recovery
No Intervention: Controlled group
non-rapid recovery



Primary Outcome Measures :
  1. To evaluate the pain, stiffness and joint function of operated limb by McMaster Universities Osteoarthritis Index(WOMAC) [ Time Frame: 6 months ]
    To evaluate the function and structure of hip joint from the aspect of pain, stiffness and joint function

  2. To evaluate the anxiety of patients post-operation by Generalized Anxiety Disorder scale-7 (GAD-7) [ Time Frame: 6 months ]
  3. To evaluate the sleep quality of patients post-operation by Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 6 months ]
  4. Insomnia severity index [ Time Frame: 6 months ]
  5. To evaluate the health related quality of life of patients post-operation by the 12-items Short Form Health Survey (SF-12) [ Time Frame: 6 months ]
  6. To evaluate the pain severity of patients post-operation by Visual Analogue Scale (VAS) Pain Score [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. C Reactive Protein (CRP) [ Time Frame: 6 months ]
  2. Erythrocyte Sedimentation Rate (ESR) [ Time Frame: 6 months ]
  3. To evaluate the quadriceps strength according to grade division standard published by British Medical Research Council [ Time Frame: 6 months ]
  4. To evaluate the swelling of operated limb by measure the thigh girth increment [ Time Frame: 6 months ]
    Calculated by operated limb thigh girth increment post-operation

  5. To evaluate the operation satisfaction of patients by Visual Analogue Scale (VAS) Satisfaction Score [ Time Frame: 6 months ]
  6. To evaluate the function of operated limb by Harris hip score (HHS) [ Time Frame: 6 months ]
  7. To evaluate the range of motion (ROM) of operated hip [ Time Frame: 6 months ]
    ROM of operated hips post-operation

  8. Length of hospital stay [ Time Frame: 3 months ]
  9. Number of dressing changes [ Time Frame: 1 month ]
    Number of dressing changes post-operation

  10. Hematocrit [ Time Frame: 6 months ]
    Pre-operation and post-operation hematocrit

  11. Haemoglobin [ Time Frame: 6 months ]
    Pre-operation and post-operation haemoglobin

  12. Number of Blood transfusion cases [ Time Frame: 1 month ]
  13. Blood transfusion volume [ Time Frame: 1 month ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Primary unilateral total hip arthroplasty;
  • 2. Patients with hip osteoarthritis,rheumatoid arthritis or femoral head necrosis;
  • 3. Able and willing to provide signed informed consent.

Exclusion Criteria:

  • 1. Simultaneously bilateral total hip arthroplasty or revision case;
  • 2. Surgical History of the hip joint;
  • 3. Hip joint cavity paracentesis in recent 3 months;
  • 4. Stiffness with hip;
  • 5. Blood coagulation disorders;
  • 6. History of deep venous thrombosis;
  • 7. Concomitant medical problems such as uncontrolled hypertension, 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. Unable to comply with polysomnographic measurement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852460


Contacts
Contact: WEINAN ZENG +8615023100103 weinanzeng@163.com

Locations
China, Chongqing
Southwest Hospital Recruiting
Chongqing, Chongqing, China, 400038
Contact: Weinan Zeng, doctor    +8615023100103    weinanzeng@163.com   
Sponsors and Collaborators
Southwest Hospital, China

Responsible Party: Liu Yang, Professor, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT02852460     History of Changes
Other Study ID Numbers: Rapid recovery
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016