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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  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 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Quality of Life

Clinical Trials on Puzzle application

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings