Evaluation of the Effectiveness of Delirium Preventive Care Protocol
NCT ID: NCT04188795
Last Updated: 2020-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
80 participants
INTERVENTIONAL
2018-05-25
2019-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of the Delirium Zero Protocol to Prevent the Onset of Delirium in Patients Undergoing Hip Fracture Surgery
NCT07202208
Prevention of Delirium Among Elderly Patients With Hip Fractures
NCT03470662
Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture
NCT04404959
Effect of Rebound Pain on Postoperative Intensive Care Delirium in Patients Undergoing Hip Surgery With Peripheral Nerve Block
NCT07295184
Postoperative Delirium in Hip Fracture Patients
NCT00564434
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This research was conducted at a training and research hospital's orthopedics and traumatology department. The study sample was compromised of 80 patients with hip fracture. Intervention and control groups were applied after block randomization. Study data was collected by using Patient Information Form, Mini-Cog Test, Confusion Assessment Method, Visual Analogue Scale, Barthel Index, Mini Nutritional Assessment-Short Form and Richards Campbell Sleep Questionnaire. The patients in the intervention group were provided with nursing care in accordance with the delirium preventive care protocol developed with the support of literature. In the control group, routine nursing care was provided in line with the clinical procedure. The data was analyzed by using number, percentage, mean, standard deviation, median, Interquartile Range, Student's t test, Mann-Whitney U test, Pearson's chi square test, Fisher corrected chi-square test, ANOVA test, Paired Sample t test, Friedman test, Wilcoxon test and Cronbach α coefficient.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
Participants who met the criteria for inclusion in the study and volunteered to participate in the study were divided into experimental and control groups by block randomization method.
After obtaining written informed consent, the Patient Information Form, Mini Nutritional Assessment- Short Form, Confusion Assessment Method, Barthel Index and Visual Analog Scale were applied to patients. Nursing care was applied to hip fracture patients in the experimental group in accordance with the care protocol developed to prevent delirium. Delirium preventive care protocol was consist of; psychosocial care, monitoring of oxygen saturation, prevention of dehydration, nutritional support, normal elimination, pain control, sleep regulation, avoidance of bladder catheterization and early mobilization.
Confusion Assessment Method, Barthel Index and Richards-Campbell Sleep Questionnaire were repeated to patients on the first postoperative day and on the third day.
Delirium Preventive Care Protocol
Nursing care was applied to hip fracture patients in the experimental group in accordance with the care protocol developed to prevent delirium. Delirium preventive care protocol was consist of; psychosocial care, monitoring of oxygen saturation, prevention of dehydration, nutritional support, normal elimination, pain control, sleep regulation, avoidance of bladder catheterization and early mobilization.
Confusion Assessment Method, Barthel Index and Richards-Campbell Sleep Questionnaire were repeated to patients on the first postoperative day and on the third day.
Control Group
After obtaining written informed consent, the Patient Information Form, Mini Nutritional Assessment- Short Form, Confusion Assessment Method, Barthel Index and Visual Analog Scale were applied to patients. Routine nursing care was applied to hip fracture patients in the control group. Confusion Assessment Method, Barthel Index and Richards-Campbell Sleep Questionnaire were repeated to patients on the first postoperative day and on the third day.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Delirium Preventive Care Protocol
Nursing care was applied to hip fracture patients in the experimental group in accordance with the care protocol developed to prevent delirium. Delirium preventive care protocol was consist of; psychosocial care, monitoring of oxygen saturation, prevention of dehydration, nutritional support, normal elimination, pain control, sleep regulation, avoidance of bladder catheterization and early mobilization.
Confusion Assessment Method, Barthel Index and Richards-Campbell Sleep Questionnaire were repeated to patients on the first postoperative day and on the third day.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 65 years and older,
* No communication problems in Turkish,
* Without cognitive impairment,
* Patients who volunteered to participate in the study
Exclusion Criteria
* Patients with dementia and Mini-Cog test less than 3 points
* Patients with a history of cerebrovascular accident
* Patients with severe comorbidity
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gulten Guvenc, Proffessor
Role: STUDY_DIRECTOR
University of Health Sciences, Gulhane Faculty of Nursing
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Heath Sciences, Gulhane Faculty of Nursing
Ankara, , Turkey (Türkiye)
University of Health Sciences, Faculty of Nursing
Ankara, , Turkey (Türkiye)
University of Health Sciences, Gulhane Faculty of Nursing
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Durst J, Wilson D. Effects of protocol on prevention of delirium in hospitalized hip fracture patients: A quality improvement project. Int J Orthop Trauma Nurs. 2020 Feb;36:100710. doi: 10.1016/j.ijotn.2019.100710. Epub 2019 Aug 1.
Holly C. Primary Prevention to Maintain Cognition and Prevent Acute Delirium Following Orthopaedic Surgery. Orthop Nurs. 2019 Jul/Aug;38(4):244-250. doi: 10.1097/NOR.0000000000000569.
Prestmo A, Hagen G, Sletvold O, Helbostad JL, Thingstad P, Taraldsen K, Lydersen S, Halsteinli V, Saltnes T, Lamb SE, Johnsen LG, Saltvedt I. Comprehensive geriatric care for patients with hip fractures: a prospective, randomised, controlled trial. Lancet. 2015 Apr 25;385(9978):1623-33. doi: 10.1016/S0140-6736(14)62409-0. Epub 2015 Feb 5.
Flikweert ER, Izaks GJ, Knobben BA, Stevens M, Wendt K. The development of a comprehensive multidisciplinary care pathway for patients with a hip fracture: design and results of a clinical trial. BMC Musculoskelet Disord. 2014 May 30;15:188. doi: 10.1186/1471-2474-15-188.
Marcantonio ER, Flacker JM, Wright RJ, Resnick NM. Reducing delirium after hip fracture: a randomized trial. J Am Geriatr Soc. 2001 May;49(5):516-22. doi: 10.1046/j.1532-5415.2001.49108.x.
Unal N, Guvenc G, Naharci M. Evaluation of the effectiveness of delirium prevention care protocol for the patients with hip fracture: A randomised controlled study. J Clin Nurs. 2022 Apr;31(7-8):1082-1094. doi: 10.1111/jocn.15973. Epub 2021 Jul 23.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
50687469-2244
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.