Quality of LifeNCT05796830
Determination of the Effect of Puzzle Use in Elderly Patients
A study testing Puzzle application in people with Quality of Life and Surgery, run by Saglik Bilimleri Universitesi.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Surgery, Postoperative Confusion
- What is being tested?
- Puzzle application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Mar 2023to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Using jigsaw puzzles regularly,
- Using drugs that affect memory and thinking
- These drugs are:
- Sedative and Hypnotic Drugs
- Benzodiazepines
- Barbiturates
Show all 14Show fewer
- 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
About this study
Official title: 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.
Read the 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.
- Being tested
- Puzzle application
- Keywords
- Postoperative Recovery, Cognitive Function, Surgery, Quality of Life, Elderly Patient
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puzzle applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | 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. Receives: Other: Puzzle application |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st, 2nd and 3rd days after the surgery
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.
Measured: 3rd day after the surgery
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.
Measured: 3rd day after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start28 Mar 2023 (estimated)
- Primary completion29 Oct 2023 (estimated)
- Study completion29 Dec 2023 (estimated)
Why it stopped: The study investigator (graduate student) discontinued their academic program, and the study was cancelled before any participant enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This studyis a single-center and randomized controlled clinical trial. Patients who accepted to participate in the study and met the inclusion criteria will be assigned to the intervention (n= 35) or control group (n= 35) according to the computer- based randomization table.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Gezginci Akpinar, Saglik Bilimleri Universitesi
- Investigators
- Emel Çanakçı, RN, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796830
- Sponsor's protocol ID
- 22-106
- Status last verified
- Sep 2026
- First submitted
- 21 Mar 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rundshagen I. Postoperative cognitive dysfunction. Dtsch Arztebl Int. 2014 Feb 21;111(8):119-25. doi: 10.3238/arztebl.2014.0119.
PubMed 24622758Fissler 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.
PubMed 28877756
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Puzzle Use on Cognitive Functions, Surgical Recovery and Quality of Life in Elderly Patients Undergoing Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT05796830
- Acronym / sponsor ID
- 22-106
- Keywords
- Postoperative Recovery, Cognitive Function, Surgery, Quality of Life, Elderly Patient
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study investigator (graduate student) discontinued their academic program, and the study was cancelled before any participant enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 28 Mar 2023 (estimated)
- Primary completion
- 29 Oct 2023 (estimated)
- Study completion
- 29 Dec 2023 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This studyis a single-center and randomized controlled clinical trial. Patients who accepted to participate in the study and met the inclusion criteria will be assigned to the intervention (n= 35) or control group (n= 35) according to the computer- based randomization table.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: Puzzle applicationBefore 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (14 listed)
- Using jigsaw puzzles regularly,
- Using drugs that affect memory and thinking
- Sedative and Hypnotic Drugs
- Anticonvulsant Drugs
- Drugs Used in Parkinson's Treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Puzzle applicationFive 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. | Other | Intervention Group |
Primary outcome
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 24622758Rundshagen I. Postoperative cognitive dysfunction. Dtsch Arztebl Int. 2014 Feb 21;111(8):119-25. doi: 10.3238/arztebl.2014.0119.
- Background: PubMed 28877756Fissler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emel Çanakçı, RN principal investigator
Saglik Bilimleri Universitesi
Questions about this trial
What is this clinical trial studying?
A study testing Puzzle application in people with Quality of Life and Surgery, run by Saglik Bilimleri Universitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Cognitive Function by the Standardized Mini-Mental Test (time frame: 1st, 2nd and 3rd days after the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05796830, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.