UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054725 |
|---|---|
| Receipt number | R000062538 |
| Scientific Title | Word Search Puzzles Intervention to Improve Cognitive Function in Geriatric Patients After General Anesthesia: Randomized Clinical Trial |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2024/06/21 06:32:10 |
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Basic information
Public title
Word Search Puzzles Intervention to Improve Cognitive Function in Geriatric Patients After General Anesthesia
Acronym
WISPIG trial
Scientific Title
Word Search Puzzles Intervention to Improve Cognitive Function in Geriatric Patients After General Anesthesia: Randomized Clinical Trial
Scientific Title:Acronym
WISPIG Randomized Clinical Trial
Region
| North America |
Condition
Condition
Geriatric patients scheduled for surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate whether the implementation of word search puzzle exercises modifies the score of cognitive status assessment determined by the Montreal Cognitive Assessment (MoCA) at 24 hours postoperative compared to its preoperative assessment 7 days before surgery in geriatric patients undergoing general anesthesia.
Basic objectives2
Others
Basic objectives -Others
1.- Investigate whether the implementation of word search puzzle exercises modifies the different domains of the Montreal Cognitive Assessment (MoCA): (1) Memory, (2) Executive Functioning, (3) Attention, (4) Language, (5) Visuospatial, and (6) Orientation, at 24 hours postoperative compared to their preoperative assessment 7 days before surgery in geriatric patients undergoing general anesthesia
2.- Investigate the impact of educational level, duration of anesthesia, type of anesthesia, and type of surgery on cognitive status assessed by the Montreal Cognitive Assessment (MoCA) at 24 hours postoperative in geriatric patients undergoing general anesthesia.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Exploring the correlation between changes in cognitive status evaluated using the Montreal Cognitive Assessment (MoCA) one week before surgery and 24 hours postoperatively, with word search puzzle exercises in geriatric patients undergoing general anesthesia
Key secondary outcomes
1.- Exploring the correlation between changes in different domains of the Montreal Cognitive Assessment (MoCA);(1) Memory, (2) Executive Functioning, (3) Attention, (4) Language, (5) Visuospatial, and (6) Orientation, evaluated one week before surgery and 24 hours postoperatively, with word search puzzle exercises in geriatric patients undergoing general anesthesia.
2.- Determining the correlation between anesthesia duration, educational level, type of anesthesia, and type of surgery with changes in cognitive function assessed using the Montreal Cognitive Assessment (MoCA) one week before surgery and 24 hours postoperatively.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
10 exercises of word search puzzle seven days before surgery
Interventions/Control_2
No exercises of word search puzzle seven days before surgery
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged between 65 and 85 years old scheduled for surgery under general anesthesia who are literate, able to write, and capable of following instructions.
Key exclusion criteria
1.- Patients with dementia or chronic neurodegenerative diseases that interfere with cognitive function.
2.- Patients unable to follow instructions or commands during the study period.
3.-Patients with cognitive impairment, defined as a MoCA score <10.
4.- Patients who cannot undergo MoCA assessment at 24 hours postoperative due to transfer to the intensive care unit and hemodynamically unstable patients during the perioperative period, defined as requiring vasopressor medications with or without endotracheal intubation.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Diego |
| Middle name | Escarraman |
| Last name | Martinez |
Organization
Instituto Mexicano del Seguro Social, Centro Medico Nacional, Hospital de Especialidades "La Raza"
Division name
Anesthesioly department
Zip code
02990
Address
Seris y Zaachila S/N, Col La Raza, Del Azcapotzalco, CdMx
TEL
+525570778209
diego-piloto@hotmail.com
Public contact
Name of contact person
| 1st name | Laura |
| Middle name | Jose |
| Last name | Juarez |
Organization
Instituto Mexicano del Seguro Social, Centro Medico Nacional, Hospital de Especialidades "La Raza"
Division name
Anesthesioly department
Zip code
02990
Address
Seris y Zaachila S/N, Col La Raza, Del Azcapotzalco, CdMx
TEL
+525517338040
Homepage URL
pepelura.josa@gmail.com
Sponsor or person
Institute
Instituto Mexicano del Seguro Social, Centro Medico Nacional, Hospital de Especialidades "La Raza"
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Instituto Mexicano del Seguro Social, Centro Medico Nacional, Hospital de Especialidades "La Raza"
Address
Seris y Zaachila S/N, Col La Raza, Del Azcapotzalco, CdMx
Tel
+5215557245900
zoquiapagj@hotmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 21 | Day |
Last modified on
| 2024 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062538
