UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062814 |
|---|---|
| Receipt number | R000071907 |
| Scientific Title | Effect of a Preoperative Surgical Explanation Video on Anxiety, Comprehension, and Postoperative Outcomes in Patients Undergoing Total Knee Arthroplasty: A Stratified, Block-Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/09/07 |
| Last modified on | 2026/09/03 20:27:23 |
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Basic information
Public title
A Study on Whether Watching an Explanatory Video Before Knee Replacement Surgery Reduces Anxiety and Improves Understanding
Acronym
Knee Surgery Video Study
Scientific Title
Effect of a Preoperative Surgical Explanation Video on Anxiety, Comprehension, and Postoperative Outcomes in Patients Undergoing Total Knee Arthroplasty: A Stratified, Block-Randomized Controlled Trial
Scientific Title:Acronym
CALM-TKA
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Total knee arthroplasty (TKA) for knee osteoarthritis is increasing with population aging. However, about 20% of patients report dissatisfaction after surgery, attributed largely to the gap between preoperative expectations and actual outcomes. Providing appropriate preoperative information and aligning patients' understanding and expectations with reality is therefore key to improving satisfaction.
Patients undergoing TKA are prone to anxiety about postoperative pain and functional recovery, yet how much insufficient preoperative information and anxiety affect satisfaction remains unclear. Studies using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) have shown a strong correlation between preoperative information requirement and anxiety, and APAIS has also been used to evaluate nurse-led patient education in TKA. Appropriate perioperative education is an important nursing role.
At our institution, preoperative explanation is given mainly verbally, and patients often express uncertainty about what they do not understand, suggesting that tension and anxiety may prevent adequate comprehension. Video-based preoperative orientation reportedly helps patients visualize the perioperative course, but evidence on how much it improves information needs and anxiety, and how this affects satisfaction, is limited. Advances in large language models (LLM) now allow staff without specialized skills to produce patient education material, but no study has examined the effect of a preoperative explanation video created using an LLM.
This study therefore aims to determine whether introducing an institution-produced, repeatedly viewable preoperative explanation video created using an LLM, covering the surgical procedure, postoperative rehabilitation, and pre- and postoperative precautions, improves comprehension, preoperative anxiety, and postoperative satisfaction in elderly patients undergoing TKA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preoperative anxiety and information requirement, assessed with the Amsterdam Preoperative Anxiety and Information Scale (APAIS, Japanese version) at the same time point.
Key secondary outcomes
Preoperative anxiety assessed with a visual analogue scale (VAS, 0-100 mm) on the day of the preoperative examination, immediately after the preoperative explanation.
Information requirement assessed with the APAIS information subscale (2 items, range 2-10) at the same time point.
Objective comprehension assessed as the number of correct answers on a 10-item multiple-choice knowledge test at the same time point.
Knee function and health-related quality of life assessed with the Knee injury and Osteoarthritis Outcome Score (KOOS) at the postoperative outpatient follow-up visit.
Knee function and patient satisfaction assessed with the Knee Society Score (KSS), including the patient satisfaction subscale, at the postoperative outpatient follow-up visit.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Standard preoperative explanation given verbally by physicians and nurses in accordance with the institution's usual practice, delivered at the preoperative examination visit.
Interventions/Control_2
The same standard verbal explanation, plus a preoperative explanation video (approximately 10 minutes) produced by our institution and supervised by our orthopedic surgeons. At the time surgery is scheduled, patients receive a printed sheet with a QR code linking to the video, which can be viewed repeatedly on the patient's own smartphone or similar device. Patients unable to view the video by themselves watch it in the outpatient clinic on the day of the preoperative examination.
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
| 65 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing total knee arthroplasty for the first time at our institution, aged 65 to 89 years, who provide written informed consent.
Key exclusion criteria
1.Patients who are unable to complete the questionnaires.
2.Patients undergoing simultaneous bilateral TKA.
3.Patients who cannot follow the standard perioperative schedule because of comorbidities or complications unrelated to the surgery itself.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Yuhei |
| Middle name | |
| Last name | Maki |
Organization
Zenshukai Hospital
Division name
Dept. of Orthpedic surgery
Zip code
379-2115
Address
54-1 Utsuboi-machi, Maebashi, Gunma 379-2115, Japan
TEL
027-261-5410
flatmen.ranch@gmail.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Maruo |
Organization
Zenshukai Hospital
Division name
Outpatient Nursing Department
Zip code
379-2115
Address
54-1 Utsuboi-machi, Maebashi, Gunma 379-2115, Japan
TEL
027-261-5410
Homepage URL
hnkknt.3026@gmail.com
Sponsor or person
Institute
Zenshukai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Zenshukai Hospital
Address
54-1 Utsuboi-machi, Maebashi, Gunma 379-2115, Japan
Tel
027-261-5410
mail@zenshukai.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
| 2026 | Year | 09 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 03 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071907
