Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06130813
Other study ID # HU-SEYMAN-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 30, 2023
Est. completion date January 30, 2024

Study information

Verified date November 2023
Source Hacettepe University
Contact Cigdem Canbolat Seyman, PHD
Phone +905335431963
Email cigdem_canbolat@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date January 30, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
increased perioperative communication program
Thanks to this communication program, informative content (8 times) will be shared with patients.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

References & Publications (5)

Clarke HD, Timm VL, Goldberg BR, Hattrup SJ. Preoperative patient education reduces in-hospital falls after total knee arthroplasty. Clin Orthop Relat Res. 2012 Jan;470(1):244-9. doi: 10.1007/s11999-011-1951-6. — View Citation

Day MA, Anthony CA, Bedard NA, Glass NA, Clark CR, Callaghan JJ, Noiseux NO. Increasing Perioperative Communication With Automated Mobile Phone Messaging in Total Joint Arthroplasty. J Arthroplasty. 2018 Jan;33(1):19-24. doi: 10.1016/j.arth.2017.08.046. E — View Citation

Karimi AH, Shah AK, Hecht CJ 2nd, Burkhart RJ, Acuna AJ, Kamath AF. Readability of Online Patient Education Materials for Total Joint Arthroplasty: A Systematic Review. J Arthroplasty. 2023 Jul;38(7):1392-1399. doi: 10.1016/j.arth.2023.01.032. Epub 2023 J — View Citation

Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33. — View Citation

Yoon RS, Nellans KW, Geller JA, Kim AD, Jacobs MR, Macaulay W. Patient education before hip or knee arthroplasty lowers length of stay. J Arthroplasty. 2010 Jun;25(4):547-51. doi: 10.1016/j.arth.2009.03.012. Epub 2009 May 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative complications The investigators expect the IPCP to reduce early postoperative complications 30 days
See also
  Status Clinical Trial Phase
Recruiting NCT03181620 - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation N/A
Recruiting NCT04205058 - Coffee After Pancreatic Surgery N/A
Completed NCT06425601 - A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy N/A
Completed NCT02565420 - Saline Versus Lactated Ringer's Solution: The SOLAR Fluid Trial N/A
Recruiting NCT04519593 - ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma N/A
Completed NCT03662672 - Rib Raising for Post-operative Ileus N/A
Completed NCT03787849 - Epigenetics in PostOperative Pediatric Emergence Delirium N/A
Active, not recruiting NCT05886387 - a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
Not yet recruiting NCT06351475 - Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy N/A
Not yet recruiting NCT05052021 - The South African Coronavirus Disease of 2019 (COVID-19) Surgical Outcomes Study
Not yet recruiting NCT03639012 - Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy N/A
Not yet recruiting NCT03591432 - A Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) and Apneic Oxygenation With Facemask Ventilation in Elderly Patients Undergoing Induction of Anaesthesia. N/A
Not yet recruiting NCT03275324 - Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients N/A
Recruiting NCT02763878 - Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy Phase 3
Completed NCT02891187 - Visits Versus Telephone Calls for Postoperative Care N/A
Completed NCT02947789 - Predictive Model for Postoperative Mortality N/A
Completed NCT02766062 - Effects of Propofol and Sevoflurane on Early POCD in Elderly Patients With Metabolic Syndrome N/A
Not yet recruiting NCT02542423 - Endocan Predictive Value in Postcardiac Surgery Acute Respiratory Failure. N/A
Recruiting NCT01934049 - Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty Phase 4
Enrolling by invitation NCT01744938 - Preoperative Biliary Drainage for the Lower Malignant Obstructive Jaundice Phase 3