Audiovisual Videodisc Education and Modification of Expectations With Total Knee Replacement (TKR)

Total Knee Replacement Clinical Trial

Official title:

Effects of an Educational Audiovisual Videodisc on Patients' Pre-operative Expectations With Total Knee Replacement: a Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463930
• Other study ID #: PSMARCOT01_2011
• Status: Completed
• Phase: N/A
• First received: October 16, 2011
• Last updated: February 18, 2016
• Start date: January 2009
• Est. completion date: April 2010

Study information

• Verified date: February 2016
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

Information provided to patients modifies their expectations with surgery. The effects of preoperative audiovisual information on expectations with total knee replacement (TKR) have not been investigated. The purposes of this study were to investigate the effectiveness of an educational videodisc on the modification of pre-operative patients' expectations with TKR and to find a biophysical profile of subjects in whom this videodisc could be most effective. It was hypothesized that patients receiving standard information plus additional medical information through audiovisual videodiscs would modify their pre-operative expectations more than those only receiving the standard information through medical interviews.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with knee osteoarthritis waiting for total knee replacement.

Exclusion Criteria:

• Cognitive disorders or language barriers precluding medical interview.

• Contralateral total knee replacement.

• History of revision total knee replacement.

• History of unicompartmental knee arthroplasty

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Behavioral:
• Educational audiovisual videodisc and medical verbal information
General and specific medical verbal information and ten-minute DVD where the process from admission to the surgical intervention, recovery room, immediate postoperative care, and outpatient care at two, six, and twelve months after surgery was shown. The video included experiences of patients with respect to pain and function and examples of functionality during daily life activities such as stairs, kneeling or squatting. The video also demonstrated the facilities and rehabilitation techniques employed in the Physical Medicine and Rehabilitation Service.
• Medical verbal information
General and specific verbal information provided by both the surgeon and a specialized nurse including basics of surgical technique, potential complications, and rehabilitation.

Locations

Country	Name	City	State
Spain	Hospital de l'Esperança - Parc de Salut MAR	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Hepinstall MS, Rutledge JR, Bornstein LJ, Mazumdar M, Westrich GH. Factors that impact expectations before total knee arthroplasty. J Arthroplasty. 2011 Sep;26(6):870-6. doi: 10.1016/j.arth.2010.09.010. Epub 2010 Nov 12. — View Citation

Mancuso CA, Salvati EA, Johanson NA, Peterson MG, Charlson ME. Patients' expectations and satisfaction with total hip arthroplasty. J Arthroplasty. 1997 Jun;12(4):387-96. — View Citation

Mancuso CA, Sculco TP, Wickiewicz TL, Jones EC, Robbins L, Warren RF, Williams-Russo P. Patients' expectations of knee surgery. J Bone Joint Surg Am. 2001 Jul;83-A(7):1005-12. — View Citation

Nilsdotter AK, Toksvig-Larsen S, Roos EM. Knee arthroplasty: are patients' expectations fulfilled? A prospective study of pain and function in 102 patients with 5-year follow-up. Acta Orthop. 2009 Feb;80(1):55-61. doi: 10.1080/17453670902805007. — View Citation

Noble PC, Conditt MA, Cook KF, Mathis KB. The John Insall Award: Patient expectations affect satisfaction with total knee arthroplasty. Clin Orthop Relat Res. 2006 Nov;452:35-43. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in patient-reported postoperative expectatives about the results of total knee replacement to inmediately after receiving audiovisual plus verbal information (intervention grou) or only verbal information (control group)	The study measures the patient's expectatives about the improvement of pain, function, and psychological well-being after undergoing total knee replacement. These expectatives are measured through the Hospital for Special Surgery Knee Replacement Expectations Survey (KRES), and a score ranging from 0 to 100 is reported.	Baseline and 1 month later (1 month before surgery)	Yes