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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05796830
Other study ID # 22-106
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 28, 2023
Est. completion date December 29, 2023

Study information

Verified date March 2023
Source Saglik Bilimleri Universitesi
Contact Emel ÇANAKÇI, RN
Phone +905454710063
Email canakciiemel@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine the effects of the use of a simple, reliable and cost-effective puzzle on post-operative cognitive function changes, postoperative recovery, and quality of life using questionnaires and face-to-face interview techniques.


Description:

Aging is a process involving biological, physiological and psychological changes. With aging, deterioration in brain, behavior and cognitive functions is observed. In this process, physical and cognitive deficiencies and slow thinking can be seen. The independence of elderly individuals in meeting their self-care decreases. Over time, individuals become unable to meet their needs and this reduces the quality of life of individuals. With the developing technology, perioperative care techniques began to develop and the number of surgical procedures applied to elderly patients began to increase.One of the most important goals in the field of health today and in the future will be to increase the quality of life of individuals. It is becoming increasingly important to determine the effective factors to protect cognitive functions in elderly individuals.After surgical procedures, patients may experience memory loss and decrease in concentration. Symptoms indicating a decrease in cognitive functions were named as postoperative cognitive dysfunction. Compared to other individuals undergoing surgery, the rate of cognitive changes in the early period is higher in the elderly.Especially, elderly patients who underwent orthopedic surgery are thought to be a risky patient group for postoperative cognitive impairment.Solving jigsaw puzzles is a low-cost, motivating, visuospatial cognitive-challenging activity.This study will be conducted in order to determine the effect of this strain on the cognitive functions of the individual and to investigate the effect of focusing on completing the puzzle on post-operative recovery and quality of life, as it will focus the individual's perception on a certain point.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date December 29, 2023
Est. primary completion date October 29, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - 65 years and older, - Having been hospitalized in the orthopedic service for at least three days after the operation, - Having undergone orthopedic surgery, - No hearing or vision problems, - Able to communicate, - No cognitive or psychiatric problems, - At least primary school graduate, - Patients who agreed to participate in the study Exclusion Criteria: - Using jigsaw puzzles regularly, - Using drugs that affect memory and thinking These drugs are: 1. Sedative and Hypnotic Drugs - Benzodiazepines - Barbiturates - Non-barbiturate - Other Sedative and Hypnotics (zolpidem, buspirone, hydroxyzine) 2. Anticonvulsant Drugs 3. Drugs Used in Parkinson's Treatment 4. Drugs Used in the Treatment of Psychiatric Diseases 5. Drugs with Narcotic Analgesic Effects 6. Anesthetic Drugs 7. Neuromuscular Blocking Drugs - Patients with cerebrovascular accident or head injury

Study Design


Intervention

Other:
Puzzle application
Five expert opinions will be taken for the puzzle application to be applied after the surgery, and the application and difficulty level of the puzzle will be decided.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi

References & Publications (2)

Fissler P, Kuster OC, Loy LS, Laptinskaya D, Rosenfelder MJ, von Arnim CAF, Kolassa IT. Jigsaw Puzzles As Cognitive Enrichment (PACE) - the effect of solving jigsaw puzzles on global visuospatial cognition in adults 50 years of age and older: study protocol for a randomized controlled trial. Trials. 2017 Sep 6;18(1):415. doi: 10.1186/s13063-017-2151-9. — View Citation

Rundshagen I. Postoperative cognitive dysfunction. Dtsch Arztebl Int. 2014 Feb 21;111(8):119-25. doi: 10.3238/arztebl.2014.0119. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Cognitive Function by the Standardized Mini-Mental Test 1st, 2nd and 3rd days after the surgery, the puzzle will be applied to the patients once a day. Then the Standardized Mini-Mental Test will be applied to the patients.This test is a measurement tool that can be easily administered within 5-10 minutes, does not include questions about mental processes, and focuses only on cognitive processes.The Standardized Mini Mental Test consists of 11 items under 5 main headings: orientation (10 points), attention and calculation (5 points), recording (3 points) and recall memory (3 points) and language (9 points). It is evaluated out of 30 points. The increase in the score obtained from the test indicates that the severity of cognitive destruction decreases. 1st, 2nd and 3rd days after the surgery
Primary Change of Postoperative Recovery by the Postoperative Recovery Index Postoperative Recovery Index will be applied on the 3rd postoperative day. Postoperative Recovery Index consists of 5 sub-dimensions and 25 items. Sub dimensions; psychological symptoms, physical activities, general symptoms, intestinal symptoms, and craving-desire symptoms. While determining the sub-dimension score, the scores of the related items are summed and their arithmetic averages are taken. For the total score; All items are summed and the arithmetic average is taken. It states that the higher the scores obtained from the index, the more difficulty in post-operative recovery, and the easier the post-operative recovery as the scores decrease. 3rd day after the surgery
Primary Change of Quality of Life by Quality of Life Scale in Older People (CASP-19) Quality of Life Scale in Older People (CASP-19) will be applied on the 3rd postoperative day. The scale consists of 19 items and four sub-dimensions. These sub-dimensions are control, autonomy, pleasure, and self-actualization. Each item of the original scale was graded as a 4-point Likert-type scale ranging from "never" (0 points) to "always" (3 points). Scale items are scored between 0 and 3 points. An increase in the score obtained from the scale indicates an increase in the quality of life. 3rd day after the surgery
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