Knee ProsthesisNCT05233423
Pressurized Cold Application for Patients Total Knee Prosthesis Surgery
A study testing compressed cold therapy bandage in people with Knee Prosthesis and Cryotherapy, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to examine the effects of pressurized cold applicatıon for patients total knee prosthesis surgery. Read more about this study
- Who is it for?
- Ages 46 to 82 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Prosthesis, Cryotherapy, Pain
- What is being tested?
- compressed cold therapy bandage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 1 Feb 2020
- 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 46 to 82 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 Years and older
- TDP surgery is planned to be performed by the same physician according to the rapid recovery protocol
- volunteer to participate in research
- had no problems in communicating cognitively, emotionally and verbally were included.
Who cannot join
- have a cold allergy
- have peripheral vascular disease
- diagnosed with Raynaud's disease
- have cognitive, affective and verbal communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pressurized Cold Application on Pain Level in Patients Wıth Total Knee Prosthesis Surgery
This study was conducted to examine the effects of pressurized cold applicatıon for patients total knee prosthesis surgery.
Read the detailed description
The study was conducted as a randomized controlled experimental study in order to determine the effect of pressurized cold application applied after total knee replacement surgery on the level of pain and satisfaction.This study was conducted in 52 patients who applied to Pamukkale University Hospitals Orthopedics and Traumatology Clinic between July 2019 and February 2020, who met the inclusion criteria and accepted to participate in the study. The patients were divided into 26 in the control group (cold gel) and 26 in the study group (compressed cold therapy bandage) using a simple randomization method. The patients in the control group received 9 cold applications, in the form of 20 minutes of application and 40 minutes of rest after surgery. The patients in the study group were applied 9 cold applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest.
- Conditions
- Knee Prosthesis, Cryotherapy, Pain, Patient Satisfaction
- Being tested
- compressed cold therapy bandage
- Medical subject headings
- Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compressed cold therapy bandageDevice
Compressed cold therapy bandage was applied by wrapping the operated knee of the patients. The patients in the intervention group received 9 cold applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The patients in the intervention group were applied 9 cold applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest. Receives: Device: compressed cold therapy bandage |
| Control Group | No intervention | The patients in the control group were applied 9 times of cold gel in the form of 20 minutes of application and 40 minutes of rest after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in pain level of total knee prothesis patients at 9 cold applicatiıon with Visual Analog Scale.
This scale was used horizontally before and after 9 cold applications to measure the pain level of the patients.
Measured: According to the fast track protocol, a total of 9 cold applications were applied to the patients who stayed in the service for an average of 1 day after the operation, except during sleep and physical therapy times.
Secondary outcomes (1)
The level of satisfaction of patients with the type of cold application applied
Satisfaction of the patients with the type of cold application applied was evaluated with a 4-point Likert question before discharge. (Very Satisfied, Satisfied, Neutral, Dissatisfied)
Measured: ,The patient was asked once before discharge (about 1 day after surgery), the level of satisfaction with the type of cold application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Jul 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ProsthesisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a parallel group randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Buldan, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233423
- Sponsor's protocol ID
- OBuldan
- Status last verified
- Dec 2021
- First submitted
- 28 Dec 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pressurized Cold Application on Pain Level in Patients Wıth Total Knee Prosthesis Surgery
- ClinicalTrials.gov ID
- NCT05233423
- Acronym / sponsor ID
- OBuldan
- Conditions
- Knee Prosthesis, Cryotherapy, Pain, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 10 Feb 2022 (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.
This study was conducted to examine the effects of pressurized cold applicatıon for patients total knee prosthesis surgery.
Detailed description
The study was conducted as a randomized controlled experimental study in order to determine the effect of pressurized cold application applied after total knee replacement surgery on the level of pain and satisfaction.This study was conducted in 52 patients who applied to Pamukkale University Hospitals Orthopedics and Traumatology Clinic between July 2019 and February 2020, who met the inclusion criteria and accepted to participate in the study. The patients were divided into 26 in the control group (cold gel) and 26 in the study group (compressed cold therapy bandage) using a simple randomization method. The patients in the control group received 9 cold applications, in the form of 20 minutes of application and 40 minutes of rest after surgery. The patients in the study group were applied 9 cold applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a parallel group randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: compressed cold therapy bandageThe patients in the intervention group were applied 9 cold applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest. |
| Control Group | No intervention | –The patients in the control group were applied 9 times of cold gel in the form of 20 minutes of application and 40 minutes of rest after surgery. |
Who may qualify
- Ages
- 46 to 82 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 Years and older
- TDP surgery is planned to be performed by the same physician according to the rapid recovery protocol
- volunteer to participate in research
- had no problems in communicating cognitively, emotionally and verbally were included.
Key exclusion criteria (4 listed)
- have a cold allergy
- have peripheral vascular disease
- diagnosed with Raynaud's disease
- have cognitive, affective and verbal communication problems
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 |
|---|---|---|
| compressed cold therapy bandageCompressed cold therapy bandage was applied by wrapping the operated knee of the patients. The patients in the intervention group received 9 cold applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest. | Device | Intervention Group |
Primary outcome
The change in pain level of total knee prothesis patients at 9 cold applicatiıon with Visual Analog Scale.
Time frame: According to the fast track protocol, a total of 9 cold applications were applied to the patients who stayed in the service for an average of 1 day after the operation, except during sleep and physical therapy times.
This scale was used horizontally before and after 9 cold applications to measure the pain level of the patients.
1 secondary outcome
The level of satisfaction of patients with the type of cold application applied
Time frame: ,The patient was asked once before discharge (about 1 day after surgery), the level of satisfaction with the type of cold application.
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 10 Feb 2022.
- 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 compressed cold therapy bandage in people with Knee Prosthesis and Cryotherapy, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 4 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 10 Feb 2022. 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 Turkey (Türkiye). 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?
The change in pain level of total knee prothesis patients at 9 cold applicatiıon with Visual Analog Scale. (time frame: According to the fast track protocol, a total of 9 cold applications were applied to the patients who stayed in the service for an average of 1 day after the operation, except during sleep and physical therapy times.). 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 10 Feb 2022.