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Determination of the Effect of Puzzle Use in Elderly Patients

Primary Purpose

Quality of Life, Surgery, Postoperative Confusion

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Puzzle application
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Quality of Life focused on measuring Postoperative Recovery, Cognitive Function, Surgery, Quality of Life, Elderly Patient

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 21, 2023
    Last Updated
    March 21, 2023
    Sponsor
    Saglik Bilimleri Universitesi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05796830
    Brief Title
    Determination of the Effect of Puzzle Use in Elderly Patients
    Official Title
    Determination of the Effect of Puzzle Use on Cognitive Functions, Surgical Recovery and Quality of Life in Elderly Patients Undergoing Orthopedic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 28, 2023 (Anticipated)
    Primary Completion Date
    October 29, 2023 (Anticipated)
    Study Completion Date
    December 29, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Saglik Bilimleri Universitesi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Quality of Life, Surgery, Postoperative Confusion, Cognitive Dysfunction
    Keywords
    Postoperative Recovery, Cognitive Function, Surgery, Quality of Life, Elderly Patient

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Puzzle application
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change of Cognitive Function by the Standardized Mini-Mental Test
    Description
    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.
    Time Frame
    1st, 2nd and 3rd days after the surgery
    Title
    Change of Postoperative Recovery by the Postoperative Recovery Index
    Description
    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.
    Time Frame
    3rd day after the surgery
    Title
    Change of Quality of Life by Quality of Life Scale in Older People (CASP-19)
    Description
    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.
    Time Frame
    3rd day after the surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emel ÇANAKÇI, RN
    Phone
    +905454710063
    Email
    canakciiemel@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elif Gezginci, Assoc. Prof.
    Phone
    +905320656343
    Email
    elif.gezginci@sbu.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emel Çanakçı, RN
    Organizational Affiliation
    Saglik Bilimleri Universitesi
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24622758
    Citation
    Rundshagen I. Postoperative cognitive dysfunction. Dtsch Arztebl Int. 2014 Feb 21;111(8):119-25. doi: 10.3238/arztebl.2014.0119.
    Results Reference
    background
    PubMed Identifier
    28877756
    Citation
    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.
    Results Reference
    background

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    Determination of the Effect of Puzzle Use in Elderly Patients

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