Determination of the Effect of Puzzle Use in Elderly Patients

NCT05796830 | Unknown

• 1 other identifier: 22-106
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Quality of Life; Surgery; Postoperative Confusion; Cognitive Dysfunction

Keywords

Postoperative Recovery, Cognitive Function, Surgery, Quality of Life, Elderly Patient

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

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.

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.

Interventions

Puzzle application OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Related Publications (2)

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

  PMID: 24622758 BACKGROUND

• 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.

  PMID: 28877756 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Emel Çanakçı, RN

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emel ÇANAKÇI, RN

CONTACT

+905454710063; canakciiemel@gmail.com

Elif Gezginci, Assoc. Prof.

CONTACT

+905320656343; elif.gezginci@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 4, 2023
• Study Start: March 28, 2023
• Primary Completion: October 29, 2023
• Study Completion: December 29, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share