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Clinical Trials/NCT04188795
NCT04188795
Completed
Not Applicable

Evaluation of the Effectiveness of Delirium Preventive Care Protocol for Hip Fracture Patients

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi3 sites in 1 country80 target enrollmentMay 25, 2018
ConditionsDelirium

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Enrollment
80
Locations
3
Primary Endpoint
Richards-Campbell Sleep Questionnaire (RCSQ)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The prospective, randomized controlled experimental trial investigates the effectiveness of delirium preventive care protocol for hip fracture patients.

Detailed Description

The aim of this prospective, randomized controlled experimental trial is to evaluate the effectiveness of delirium preventive care protocol on pain, functional status, sleep quality and delirium prevention in patients with hip fracture. 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.

Registry
clinicaltrials.gov
Start Date
May 25, 2018
End Date
April 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Planned surgery for hip fracture,
  • 65 years and older,
  • No communication problems in Turkish,
  • Without cognitive impairment,
  • Patients who volunteered to participate in the study

Exclusion Criteria

  • Patients who could not be evaluated by the investigator before the operation
  • Patients with dementia and Mini-Cog test less than 3 points
  • Patients with a history of cerebrovascular accident
  • Patients with severe comorbidity

Outcomes

Primary Outcomes

Richards-Campbell Sleep Questionnaire (RCSQ)

Time Frame: 4 minutes.

It was applied to patients at first admission to the clinic, on the first and third postoperative day. The scale developed by Richards in 1987; It consists of six items that assess the depth of night's sleep, the time to fall asleep, the frequency of waking up, the time to wake up, the quality of sleep and the noise level in the environment. Each item is evaluated on the chart from 0 to 100. A score of 0-25 indicates a very poor sleep and a score of '76 -100 indicates a very good sleep. The higher the scale score, the better the sleep quality of the patients. The total sleep score is calculated by taking the average of the depth of sleep, the time to fall asleep, the frequency of waking up, the time to stay awake and the quality of sleep.

Visual Analog Scale (VAS)

Time Frame: 1 minute.

It was applied to patients at first admission to the clinic, on the first and third postoperative day. It is used to measure the severity of pain. It is easy to use and the same in every language. At the two ends of a ten-centimeter line, two end definitions of the parameter to be evaluated are written and the patient is asked to indicate where his or her condition is appropriate by drawing a line or by pointing or pointing (0: I have no pain, 10: I have unbearable pain). The length of the distance from the absence of pain to the location of the patient indicates the pain of the patient. Less than three of this numerical expression indicates mild pain, three to seven indicates moderate pain, and more than seven indicates severe pain.

Mini Nutritional Assesment- Short Form (MNA-SF)

Time Frame: 2 minutes.

It was applied to patients at first admission to the clinic for evaluating of malnutrition. Its use in the elderly is recommended by the European Society for Clinical Nutrition and Metabolism (ESPEN). According to the screening score; 0-7 points indicate malnutrition, 8-11 points indicate malnutrition risk, 12-14 points indicate normal nutritional status.

Barthel Index (BI)

Time Frame: 5 minutes.

Patients filled at frst admission to the clinic, on the first and third postoperative day was developed in 1965 by Mahoney and Barthel. It is used to determine the level of independence of individuals in their activities. The Barthel Index measures the social and physical function of daily life and consists of 10 items that assess the individual's ability to meet daily functions (nutrition, bathing, personal care, dressing, toileting, mobility on flat surfaces, transfer, climbing stairs, bowel and bladder function) without assistance. Each item is scored between 0-15 (varies according to the question). Barthel Index total scores vary between 0-100; 0-20 points completely addiction; 21-61 points severe addiction; Moderate dependence of 62-90 points; 91-99 points mild addiction; 100 points explain independence. In the studies using the Barthel Index, 60 points were taken as the limit and scores above 60 explain the ability to function independently.

Study Sites (3)

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