Increased Perioperative Communication Program in Knee Arthroplasty

November 14, 2023 updated by: Çiğdem Canbolat Seyman, Hacettepe University

Effect of Increased Perioperative Communication Program on Short-Term Complications in Elective Primary Knee Arthroplasty Patients: A Randomized Controlled Trial

Total knee replacement (TKA) is a surgical procedure to increase the function of the knee joint. However, in the postoperative period, it takes a long time for patients to gain independence and adapt to daily life, and they need information and support. The aim of this study is to determine the effect of the increased perioperative communication program (IPCP) in patients with TKA on early postoperative complications.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Total knee replacement (TKA) is a surgical procedure to increase the function of the knee joint. However, in the postoperative period, it takes a long time for patients to gain independence and adapt to daily life, and they need information and support. The aim of this study is to determine the effect of the increased perioperative communication program (IPCP) in patients with TKA on early postoperative complications. This study was approved by the Clinical Research Ethics Committee of Ankara Bilkent City Hospital (No:E1/3573/2023). The population of this study will consist of patients who applied to Ankara Bilkent City Hospital, Orthopedics and Traumatology Outpatient Clinic due to knee osteoarthritis and who are planned to undergo elective total knee arthroplasty. Patients who are planned for elective primary unilateral knee arthroplasty, have a smartphone, are literate, have no communication problems and agree to participate in the study will be included in the study; Patients with revision total knee arthroplasty, bilateral total knee arthroplasty, speech and hearing disabilities, cognitive problems such as Alzheimer's and dementia, and patients who do not agree to participate in the study will be excluded from the study. The sample of the research is; it was determined as 70 patients by G. Power analysis based on the correlation coefficients in a sample study. 35 of the patients will be assigned to the intervention group (IG) and 35 to the control group (CG). Patients in the CG will receive routine perioperative care, while patients in the IG will be included in the IPCP. All patients will be followed for one month after discharge. IPCP consists of 8 informative contents such as preoperative preparations, surgical procedure, pain management, first mobilization, knee joint movements, exercise, discharge process, wound care, showering, nutrition, daily living activities, driving, sexual life, postoperative routine control, unexpected situations and etc. These informative contents will send to patients on days 7th, 4t and 1th days before the surgery and on days 1th, 2th, 3th, 5th an 7th days after surgery via whatsapp. Additionally, all participants will follow postoperative one month. Data will collect using Personal Information Form and Problems Experienced After Discharge Form. Data will analyze using IBM SPSS version 23.0.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Elective primary unilateral knee arthroplasty planned,
  • Having a smartphone,
  • Literate,
  • Have no communication problems and
  • Agreed to participate in the study were included.

Exclusion Criteria:

  • Those with revision total knee arthroplasty
  • Those with bilateral total knee arthroplasty
  • Those with speech and hearing disabilities and cognitive problems such as Alzheimer's and dementia
  • Patients who do not agree to participate in the study will be excluded from the study.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Increased perioperative communication program
The sample of the research is; it was determined as 70 patients by G. Power analysis based on the correlation coefficients in a sample study. 35 of the patients will be assigned to the intervention group (IG) and 35 to the control group (CG). Patients in the CG will receive routine perioperative care, while patients in the IG will be included in the IPCP. All patients will be followed for one month after discharge. IPCP consists of 8 informative contents such as preoperative preparations, surgical procedure, pain management, first mobilization, knee joint movements, exercise, discharge process, wound care, showering, nutrition, daily living activities, driving, sexual life, postoperative routine control, unexpected situations and etc. These informative contents will send to patients on days 7th, 4t and 1th days before the surgery and on days 1th, 2th, 3th, 5th an 7th days after surgery via whatsapp. Additionally, all participants will follow postoperative one month.
Other: increased perioperative communication program
Thanks to this communication program, informative content (8 times) will be shared with patients.
No Intervention: Standart of care
Patients in the control group will receive routine perioperative care and will follow postoperative for one month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 30 days
The investigators expect the IPCP to reduce early postoperative complications
30 days

Collaborators and Investigators

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

Sponsor

Hacettepe University

Investigators

  • Study Director: Cigdem Canbolat Seyman, PHD, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

November 30, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

January 30, 2024

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HU-SEYMAN-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will talk about sharing data with other researchers. But it can be useful.

IPD Sharing Time Frame

March 2024

IPD Sharing Access Criteria

Data from this study can be open to all other clinical trial researchers.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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