Cold TherapyNCT06262022
The Effect of Cold Application on Pain Level, Edema and Drainage Amount
A study testing cold therapy in people with Cold Therapy and Pain, Postoperative, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aimed to investigate the effect of cold application applied for 20 minutes every hour for 8 hours on the first day, second and third days after total hip arthroplasty with gel pads, on the pain level, edema and drainage amount of total hip arthroplasty patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cold Therapy, Pain, Postoperative
- What is being tested?
- cold therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 30 Apr 2024
- 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 and above,
- Able to communicate verbally and in writing,
- Turkish speaking,
- TKA applied for the first time,
- Unilateral total knee arthroplasty applied,
- Spinal anesthesia applied,
- Having a hemovac drainage catheter,
- Without peripheral vascular disease,
Who cannot join
- Revision total knee arthroplasty applied,
- Bilateraltotal knee arthroplasty applied,
- Those who use alcohol and substances,
- TKA was performed for a reason other than knee osteoarthritis,
- General anesthesia applied,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karamanoğlu Mehmet bey Üniversitesi
Merkez, Karaman, 70100
fatma gök, 05544906142, fatmagok123@gmail.com
About this study
Official title: The Effect of Cold Application on Pain Level, Edema and Drainage Amount in Patients With Total Knee Arthroplasty: A Randomized Controlled Study
In this study, we aimed to investigate the effect of cold application applied for 20 minutes every hour for 8 hours on the first day, second and third days after total hip arthroplasty with gel pads, on the pain level, edema and drainage amount of total hip arthroplasty patients. The main question[s]it aims to answer are:
- Is there a difference between the pain levels of patients in the control and cold application arms?
- Is there a difference between the knee edema of patients in the control and cold application arms?
- Is there a difference between the amount of drainage of patients in the control and cold application arms? This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT).
Read the detailed description
- When the patient arrives at the service after TKA, cold application will begin with gel pads at 0 ºC and continue for eight hours. After TKA, cold application will continue for 20 minutes every hour between 08.00-16.00 on the 1st and 2nd day.
- After TKA, pain intensity will be evaluated and at the 6th, 24th and 48th hours.
- Knee circumference measurements for knee edema will be made before TKA and at the 24th and 48th hours after TKA.
- After being taken to bed after TKA, the amount of drainage will be measured at the 1st, 6th and 24th hours.
- In the first 24 hours and 24-48 hours after TKA. Analgesic consumption between hours will be recorded.
- Knee temperature will be measured before and after each cold application.
- Knee temperature will be measured before and after each cold application. Measurements of the control group will be made at the specified times in the cold application group. Cold application will not be applied to the control group.
- Conditions
- Cold Therapy, Pain, Postoperative
- Being tested
- cold therapy
- Keywords
- cold therapy, pain, patient, knee arthroplasty
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold therapyOther
A cold ice pack will be applied to the patient's knee for 20 minutes every hour for three days, starting after total knee arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | A cold ice pack will be applied to the patient's knee for 20 minutes every hour for three days, starting after total knee arthroplasty. Receives: Other: cold therapy |
| control arm | No intervention | Only unit-specific routine treatment and care interventions will be applied to the patients in the control arm by the team in the unit, and no intervention will be applied by the researcher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain level
Pain level of patients will be measured after total knee arthroplasty ( Visual Analogue Scale (VAS) is a 10 cm ruler with "no pain" written on one end and "the worst possible pain" written on the other end. Patients mark the levels on the ruler according to their pain levels. 1-3 points on the scale are rated as mild, 4-6 points as moderate and 7-10 points as severe pain.)
Measured: After total knee arthroplasty, pain intensity will be evaluated at the 6th, 24th and 48th hours.
Secondary outcomes (2)
edema
The knee circumference of patients will be measured before total knee arthroplasty and will be measured again at 24 and 48 hours after surgery.
Measured: Knee circumference measurements for knee edema will be made before total knee arthroplasty and at the 24th and 48th hours after total knee arthroplasty.
amount of drainage
The amount coming from the drain after total knee arthroplasty will be measured
Measured: After being taken to bed after total knee arthroplasty, the amount of drainage will be measured at the 1st, 6th and 24th hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start15 Jan 2024
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cold TherapyStudies 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 was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT).
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Responsible party
- Principal investigator, Fatma GÖK, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262022
- Sponsor's protocol ID
- KaramanogluMehmetbeyUFGok
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 15 Feb 2024
- 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 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Application on Pain Level, Edema and Drainage Amount in Patients With Total Knee Arthroplasty: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06262022
- Acronym / sponsor ID
- KaramanogluMehmetbeyUFGok
- Conditions
- Cold Therapy, Pain, Postoperative
- Keywords
- cold therapy, pain, patient, knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 15 Feb 2024 (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.
In this study, we aimed to investigate the effect of cold application applied for 20 minutes every hour for 8 hours on the first day, second and third days after total hip arthroplasty with gel pads, on the pain level, edema and drainage amount of total hip arthroplasty patients. The main question[s]it aims to answer are:
- Is there a difference between the pain levels of patients in the control and cold application arms?
- Is there a difference between the knee edema of patients in the control and cold application arms?
- Is there a difference between the amount of drainage of patients in the control and cold application arms? This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT).
Detailed description
- When the patient arrives at the service after TKA, cold application will begin with gel pads at 0 ºC and continue for eight hours. After TKA, cold application will continue for 20 minutes every hour between 08.00-16.00 on the 1st and 2nd day.
- After TKA, pain intensity will be evaluated and at the 6th, 24th and 48th hours.
- Knee circumference measurements for knee edema will be made before TKA and at the 24th and 48th hours after TKA.
- After being taken to bed after TKA, the amount of drainage will be measured at the 1st, 6th and 24th hours.
- In the first 24 hours and 24-48 hours after TKA. Analgesic consumption between hours will be recorded.
- Knee temperature will be measured before and after each cold application.
- Knee temperature will be measured before and after each cold application. Measurements of the control group will be made at the specified times in the cold application group. Cold application will not be applied to the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Other: cold therapyA cold ice pack will be applied to the patient's knee for 20 minutes every hour for three days, starting after total knee arthroplasty. |
| control arm | No intervention | –Only unit-specific routine treatment and care interventions will be applied to the patients in the control arm by the team in the unit, and no intervention will be applied by the researcher. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years and above,
- Able to communicate verbally and in writing,
- Turkish speaking,
- TKA applied for the first time,
- Unilateral total knee arthroplasty applied,
Key exclusion criteria (5 listed)
- Revision total knee arthroplasty applied,
- Bilateraltotal knee arthroplasty applied,
- Those who use alcohol and substances,
- TKA was performed for a reason other than knee osteoarthritis,
- General anesthesia applied,
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 |
|---|---|---|
| cold therapyA cold ice pack will be applied to the patient's knee for 20 minutes every hour for three days, starting after total knee arthroplasty. | Other | experimental arm |
Primary outcome
pain level
Time frame: After total knee arthroplasty, pain intensity will be evaluated at the 6th, 24th and 48th hours.
Pain level of patients will be measured after total knee arthroplasty ( Visual Analogue Scale (VAS) is a 10 cm ruler with "no pain" written on one end and "the worst possible pain" written on the other end. Patients mark the levels on the ruler according to their pain levels. 1-3 points on the scale are rated as mild, 4-6 points as moderate and 7-10 points as severe pain.)
2 secondary outcomes
edema
Time frame: Knee circumference measurements for knee edema will be made before total knee arthroplasty and at the 24th and 48th hours after total knee arthroplasty.
amount of drainage
Time frame: After being taken to bed after total knee arthroplasty, the amount of drainage will be measured at the 1st, 6th and 24th hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold therapy in people with Cold Therapy and Pain, Postoperative, run by Karamanoğlu Mehmetbey 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fatma gök (05544906142, fatmagok123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain level (time frame: After total knee arthroplasty, pain intensity will be evaluated at the 6th, 24th and 48th hours.). 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 15 Feb 2024.