Osteoarthritis, KneeNCT05703087
Positive Cueing in Knee Arthroplasty.
A study testing Positive cueing in the information video before a primary TKA in people with Osteoarthritis, Knee and Psychological Stress, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
To the knowledge of the investigators, the feasibility of an RCT assessing the use of positive cueing in an information video for patients undergoing primary TKA is currently unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Psychological Stress, Mental Stress
- What is being tested?
- Positive cueing in the information video before a primary TKA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Sep 2021to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- end-stage knee osteoarthritis for which participants were scheduled for a TKA
- sufficient Dutch languages skills to understand the information video
- able to fill out the questionnaires.
Who cannot join
- not receiving TKA for osteoarthritis of the knee
- not sufficient Dutch languages skills to understand the information video
- not able to fill out the questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Positive Cueing in the Information Video for Patients Undergoing Total Knee Arthroplasty: a Feasibility Study for a Randomized Controlled Trial.
To the knowledge of the investigators, the feasibility of an RCT assessing the use of positive cueing in an information video for patients undergoing primary TKA is currently unclear.
The investigators conducted a feasibility study with the primary objective to assess the acceptability of the randomized controlled trial (RCT) procedure for participating patients. The secondary objective was to evaluate the rate of recruitment, the comprehensibility (do patients understand what is expected of them during the trial) and if there were any adjustments necessary to the design of the study. The outcome of the current feasibility study will be used to determine whether adjustments are required to the design of the RCT before we proceed.
Read the detailed description
Even though total knee arthroplasty (TKA) is a cost-effective treatment, 10 - 34% of the patients report pain and discomfort up to two years after the procedure. Preoperative symptoms of anxiety and/or depression (which is present in approximately 10 - 58.6% of TKA patients seem to be related to poor pain coping techniques, which can lead to higher levels of pain up to two years after surgery. Our previous systematic review showed that a reduction of preoperative symptoms of anxiety and depression may lead to a reduction of postoperative pain after TKA.
In radiology, anesthesiology, and pediatric departments multiple studies have been performed on reducing the perception of pain with the use of language and hypnosis. This led to the concept of positive cueing. With positive cueing, general language without negative suggestions is used in provided information and instructions about the management of potential discomfort. Correct use of positive cueing has been shown to improve patients' satisfaction and to decrease need for additional treatments (such as blood transfusion) after several medical procedures, whereas use of negative language (warning patients for pain or negative experiences) seems to result in higher pain and anxiety scores.
Before TKA, patients are informed about the procedure and the risk of complications. Positive cueing might positively influence perioperative anxiety symptoms and subsequently improve pain after TKA. The investigators plan to conduct a randomized controlled trial (RCT) to address the question whether the use of positive cueing in the information video for patients undergoing a primary TKA, compared to the standard care video, will reduce the level of preoperative symptoms of anxiety and improve pain coping styles.
To the knowledge of the reviewers, no previous studies addressed this topic. Hence, the feasibility of an RCT assessing the use of positive cueing in an information video for patients undergoing primary TKA is currently unclear. As such, this feasibility study was conducted with the primary objective to assess the acceptability of the RCT procedure for participating patients. Secondly, the rate of recruitment, the comprehensibility (do patients understand what is expected of them during the trial) and if there were any adjustments necessary to the design of the study were evaluated. The outcome of the current feasibility study will be used to determine whether adjustments are required to the design of the RCT before the investigators proceed.
- Conditions
- Osteoarthritis, Knee, Psychological Stress, Mental Stress
- Being tested
- Positive cueing in the information video before a primary TKA
- Medical subject headings
- Osteoarthritis, Knee, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive cueing in the information video before a primary TKABehavioural
Two weeks before the surgery, in the outpatient clinic (during their preoperative appointment), the pre-surgery information video was shown to the patients. Patients were randomly allocated to either the positive cueing group (intervention) or the standard care group (control) with Castor EDC (14) using a variable block randomization model. Patients did not know whether they watched the adapted video or the standard video.
| Study group | Role | What they receive |
|---|---|---|
| Standard information video before primary total knee arthroplasty | No intervention | Information video (about procedure, complications, rehabilitation) shown to the participants before TKA in the OLVG. |
| Positive cueing in the information video before a primary total knee arthroplasty | Experimental | The information video was adapted from the existing standard information video used in OLVG. The concept of positive cueing was applied to the standard video by an expert team including a psychiatrist and clinical psychologist. Illustrations which were incomprehensible or with negative associations were removed.
Four rules were followed to use positive cueing:
1. make patients aware that they are able to influence their own recovery process,
2. be descriptive in explanations; objectively describe the performed procedure, name equivalent, not negatively charged feelings,
3. explain why specific steps and actions during the procedure are performed, so the patients understand what is going to happen,
4. do not use medical langue, but use accessible, understandable language instead. Receives: Behavioral: Positive cueing in the information video before a primary TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcome measure: acceptibility.
The primary feasibility outcome score was the acceptability to participate, assessed with a developed questionnaire.
The investigators conducted a questionnaire about the experience of the participants with a Likart scale 1 - 5, existing of 4 questions. A total score of 12 or higher was interpreted as acceptable since the patient seemed have a positive experience according to the questionnaire. As part of the primary outcome measure (acceptibility), we monitored the time it took a patient to participate in the study. The study should not take more than one hour to be acceptable.
Measured: During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires.
Secondary outcomes (3)
Feasibility outcome measure: rate of recruitment
We determined the rate of recruitment by dividing the number of patients included in this study by the number of patients waiting for total knee arthroplasty meeting all inclusion criteria who were scheduled to be seen on the preoperative outpatient clinic appointment.
Measured: The number of the patients on the waiting list for total knee arthroplasty and the included patients were assessed two weeks before surgery, during the outpatient clinic visit.
Feasibility outcome measure: comprehensibility
Do patients understand what is expected of them during the trial. We analyzed comprehensibility for the patients with a developed questionnaire with a cut off point < 9 and by assessing the rate of completion of the questionnaires (number of questions completed). Specific items that were consistently missing from the questionnaires and were not filled out by the patients were noted. Also, patients received one question about whether they thought the information in the video was easy to understand, cut off point < 3.
Measured: During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires.
Feasibility outcome measure:patients' feedback to the current protocol.
After finishing the questionnaire we asked two feedback questions regarding the protocol:
- what patients thought of participating in the study, and
- whether they had suggestions to improve the study process. The feedback from the patients were transcribed and similar answers were categorized.
Measured: During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start21 Sep 2021
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center feasibility study. We compared the use of positive cueing in the information video before a primary total knee arthorplasty (TKA) with the standard information video.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Onze Lieve Vrouwe Gasthuis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Principal investigator, Rudolf W Poolman, MD PhD, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703087
- Sponsor's protocol ID
- WO 21.122
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2023
- Last updated
- 27 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positive Cueing in the Information Video for Patients Undergoing Total Knee Arthroplasty: a Feasibility Study for a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05703087
- Acronym / sponsor ID
- WO 21.122
- Conditions
- Osteoarthritis, Knee, Psychological Stress, Mental Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Onze Lieve Vrouwe Gasthuis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To the knowledge of the investigators, the feasibility of an RCT assessing the use of positive cueing in an information video for patients undergoing primary TKA is currently unclear.
The investigators conducted a feasibility study with the primary objective to assess the acceptability of the randomized controlled trial (RCT) procedure for participating patients. The secondary objective was to evaluate the rate of recruitment, the comprehensibility (do patients understand what is expected of them during the trial) and if there were any adjustments necessary to the design of the study. The outcome of the current feasibility study will be used to determine whether adjustments are required to the design of the RCT before we proceed.
Detailed description
Even though total knee arthroplasty (TKA) is a cost-effective treatment, 10 - 34% of the patients report pain and discomfort up to two years after the procedure. Preoperative symptoms of anxiety and/or depression (which is present in approximately 10 - 58.6% of TKA patients seem to be related to poor pain coping techniques, which can lead to higher levels of pain up to two years after surgery. Our previous systematic review showed that a reduction of preoperative symptoms of anxiety and depression may lead to a reduction of postoperative pain after TKA.
In radiology, anesthesiology, and pediatric departments multiple studies have been performed on reducing the perception of pain with the use of language and hypnosis. This led to the concept of positive cueing. With positive cueing, general language without negative suggestions is used in provided information and instructions about the management of potential discomfort. Correct use of positive cueing has been shown to improve patients' satisfaction and to decrease need for additional treatments (such as blood transfusion) after several medical procedures, whereas use of negative language (warning patients for pain or negative experiences) seems to result in higher pain and anxiety scores.
Before TKA, patients are informed about the procedure and the risk of complications. Positive cueing might positively influence perioperative anxiety symptoms and subsequently improve pain after TKA. The investigators plan to conduct a randomized controlled trial (RCT) to address the question whether the use of positive cueing in the information video for patients undergoing a primary TKA, compared to the standard care video, will reduce the level of preoperative symptoms of anxiety and improve pain coping styles.
To the knowledge of the reviewers, no previous studies addressed this topic. Hence, the feasibility of an RCT assessing the use of positive cueing in an information video for patients undergoing primary TKA is currently unclear. As such, this feasibility study was conducted with the primary objective to assess the acceptability of the RCT procedure for participating patients. Secondly, the rate of recruitment, the comprehensibility (do patients understand what is expected of them during the trial) and if there were any adjustments necessary to the design of the study were evaluated. The outcome of the current feasibility study will be used to determine whether adjustments are required to the design of the RCT before the investigators proceed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A single-center feasibility study. We compared the use of positive cueing in the information video before a primary total knee arthorplasty (TKA) with the standard information video.
| Arm | Type | Receives |
|---|---|---|
| Standard information video before primary total knee arthroplasty | No intervention | –Information video (about procedure, complications, rehabilitation) shown to the participants before TKA in the OLVG. |
| Positive cueing in the information video before a primary total knee arthroplasty | Experimental | Behavioral: Positive cueing in the information video before a primary TKAThe information video was adapted from the existing standard information video used in OLVG. The concept of positive cueing was applied to the standard video by an expert team including a psychiatrist and clinical psychologist. Illustrations which were incomprehensible or with negative associations were removed. Four rules were followed to use positive cueing: 1. make patients aware that they are able to influence their own recovery process, 2. be descriptive in explanations; objectively describe the performed procedure, name equivalent, not negatively charged feelings, 3. explain why specific steps and actions during the procedure are performed, so the patients understand what is going to happen, 4. do not use medical langue, but use accessible, understandable language instead. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- end-stage knee osteoarthritis for which participants were scheduled for a TKA
- sufficient Dutch languages skills to understand the information video
- able to fill out the questionnaires.
Key exclusion criteria (3 listed)
- not receiving TKA for osteoarthritis of the knee
- not sufficient Dutch languages skills to understand the information video
- not able to fill out the questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive cueing in the information video before a primary TKATwo weeks before the surgery, in the outpatient clinic (during their preoperative appointment), the pre-surgery information video was shown to the patients. Patients were randomly allocated to either the positive cueing group (intervention) or the standard care group (control) with Castor EDC (14) using a variable block randomization model. Patients did not know whether they watched the adapted video or the standard video. | Behavioural | Positive cueing in the information video before a primary total knee arthroplasty |
Primary outcome
Feasibility outcome measure: acceptibility.
Time frame: During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires.
The primary feasibility outcome score was the acceptability to participate, assessed with a developed questionnaire. The investigators conducted a questionnaire about the experience of the participants with a Likart scale 1 - 5, existing of 4 questions. A total score of 12 or higher was interpreted as acceptable since the patient seemed have a positive experience according to the questionnaire. As part of the primary outcome measure (acceptibility), we monitored the time it took a patient to participate in the study. The study should not take more than one hour to be acceptable.
3 secondary outcomes
Feasibility outcome measure: rate of recruitment
Time frame: The number of the patients on the waiting list for total knee arthroplasty and the included patients were assessed two weeks before surgery, during the outpatient clinic visit.
Feasibility outcome measure: comprehensibility
Time frame: During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires.
Feasibility outcome measure:patients' feedback to the current protocol.
Time frame: During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive cueing in the information video before a primary TKA in people with Osteoarthritis, Knee and Psychological Stress, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcome measure: acceptibility. (time frame: During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023; AzTrials last refreshed its copy on 30 Oct 2026.