- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05796830
Determination of the Effect of Puzzle Use in Elderly Patients
March 21, 2023 updated by: Elif Gezginci, Saglik Bilimleri Universitesi
Determination of the Effect of Puzzle Use on Cognitive Functions, Surgical Recovery and Quality of Life in Elderly Patients Undergoing Orthopedic Surgery
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
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
- Name: Emel ÇANAKÇI, RN
- Phone Number: +905454710063
- Email: canakciiemel@gmail.com
Study Contact Backup
- Name: Elif Gezginci, Assoc. Prof.
- Phone Number: +905320656343
- Email: elif.gezginci@sbu.edu.tr
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
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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:
Sedative and Hypnotic Drugs
- Benzodiazepines
- Barbiturates
- Non-barbiturate
- Other Sedative and Hypnotics (zolpidem, buspirone, hydroxyzine)
- Anticonvulsant Drugs
- Drugs Used in Parkinson's Treatment
- Drugs Used in the Treatment of Psychiatric Diseases
- Drugs with Narcotic Analgesic Effects
- Anesthetic Drugs
- Neuromuscular Blocking Drugs - Patients with cerebrovascular accident or head injury
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Intervention Group
Before the operation, the rules of the puzzle will be explained to the patients in the intervention group and how it will be applied will be shown.
Then, Patient Diagnosis Form, Mini-Mental State Test and Quality of Life Scale will be administered.On the 1st, 2nd and 3rd days after the surgery, the rules of the puzzle will be reminded again and the puzzle will be applied to the patients once a day.
After the puzzle application on the 1st, 2nd and 3rd days after the surgery, the Mini-Mental State Test will be applied to the patients.
Postoperative Recovery Index and Quality of Life Scale will be applied on the 3rd postoperative day.
|
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.
|
|
No Intervention: Control Group
Patients in the control group will be followed according to routine clinical procedure.
Since there are no procedures or interventions in clinical procedures, only patient monitoring will be performed.
The patients in the control group will also be followed and evaluated with the same forms at the same time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Cognitive Function by the Standardized Mini-Mental Test
Time Frame: 1st, 2nd and 3rd days after the surgery
|
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
|
|
Change of Postoperative Recovery by the Postoperative Recovery Index
Time Frame: 3rd day after the surgery
|
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
|
|
Change of Quality of Life by Quality of Life Scale in Older People (CASP-19)
Time Frame: 3rd day after the surgery
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emel Çanakçı, RN, Saglik Bilimleri Universitesi
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
- Rundshagen I. Postoperative cognitive dysfunction. Dtsch Arztebl Int. 2014 Feb 21;111(8):119-25. doi: 10.3238/arztebl.2014.0119.
- 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.
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 (Anticipated)
March 28, 2023
Primary Completion (Anticipated)
October 29, 2023
Study Completion (Anticipated)
December 29, 2023
Study Registration Dates
First Submitted
March 21, 2023
First Submitted That Met QC Criteria
March 21, 2023
First Posted (Actual)
April 4, 2023
Study Record Updates
Last Update Posted (Actual)
April 4, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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