Personal SatisfactionNCT05264844
Peripheral Venous Catheter and Masking Tape
A study testing Masking tape in people with Personal Satisfaction and Pain, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
urpose: This study will be carried out to determine the effect of two different catheter covers on the comfort, satisfaction, pain level of the patient and the satisfaction of the nurse. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Personal Satisfaction, Pain, Comfort
- What is being tested?
- Masking tape
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 20 Sep 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65
- Being open to communication and cooperation
- Being conscious and able to answer questions
- Volunteering for research
- Being receiving chemotherapy treatment with a peripheral venous catheter
Who cannot join
- Having a disease that may affect the ability to make decisions (dementia, psychological disorders, etc.)
- Having sensory losses such as vision and hearing
- Being in terminal period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Two Different Catheter Covers on Patient's Comfort, Satisfaction, Pain Level and Nurse's Satisfaction Randomized Controlled Study"
urpose: This study will be carried out to determine the effect of two different catheter covers on the comfort, satisfaction, pain level of the patient and the satisfaction of the nurse.
Materials and Methods: This study, which is planned as an open-label randomized controlled post-test study, will be carried out between December 2021 and February 2022. Data; Descriptive Properties will be collected with the Information Form and Visual Analog Scale (Visual Analog Scale-VAS). Data will be collected face to face by researchers.
Read the detailed description
Peripheral venous catheter (PVK) is applied to patients who apply to the hospital due to outpatient chemotherapy and need to receive treatment by intravenous route. This application is carried out by nurses. During their education, nurses receive theoretical and practical training on PVC applications. Nurses; They are the primary health professionals who are responsible for determining the PVC site, deciding on the catheter number to be used, applying the correct technique, performing the recommended intravenous (IV) interventions, following the complications that may develop by performing the necessary controls, ensuring the continuity of the application and providing catheter care.
The effective application of interventions such as transfusion of intravenous fluids, chemotherapy drugs, blood and blood products, and total parenteral feeding in cancer patients is provided by PVK. The application of PVC is a necessity for the treatment of the individual receiving treatment and may cause pain, deterioration in comfort and dissatisfaction. Although the widespread use of peripheral venous catheters provides great benefits, it has been reported that undesirable events such as phlebitis, infiltration, obstruction, leakage, and rarely infection occur when applied incorrectly and inadequately. In order for peripheral venous catheters to be used effectively in treatment, it is important to fix them with the correct technique. Detection becomes more important in the use of chemotherapy agents. The patches used for fixation adhere to the glove and are difficult to remove from the patient's skin. Therefore, both the nurse and the patient feel discomfort. For this reason, it would be appropriate to use a material that can be easily torn off with a glove, does not adhere to the glove, and fixes the patient's catheter well. This product should also be able to be easily removed without harming the patient's skin.
- Conditions
- Personal Satisfaction, Pain, Comfort
- Being tested
- Masking tape
- Keywords
- Peripheral venous catheter, chemotherapy, patch, fixation
- Medical subject headings
- Personal Satisfaction, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masking tapeOther
IV catheters will be fixed with masking tape
| Study group | Role | What they receive |
|---|---|---|
| masking tape group | Experimental | Masking tape will be used Receives: Other: Masking tape |
| standard catheter dressing group | No intervention | Medical plaster to be used (It is routine practice in the clinic.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
To be evaluated with "Visual analog scale"
Measured: a week
Patient comfort
To be evaluated with "Visual analog scale"
Measured: a week
Nurse's practice satisfaction
To be evaluated with "Visual analog scale"
Measured: a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 May 2022
- Primary completion1 Aug 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personal SatisfactionStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rukiye Burucu, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264844
- Sponsor's protocol ID
- 123456
- Status last verified
- Feb 2023
- First submitted
- 19 Jan 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Two Different Catheter Covers on Patient's Comfort, Satisfaction, Pain Level and Nurse's Satisfaction Randomized Controlled Study"
- ClinicalTrials.gov ID
- NCT05264844
- Acronym / sponsor ID
- 123456
- Conditions
- Personal Satisfaction, Pain, Comfort
- Keywords
- Peripheral venous catheter, chemotherapy, patch, fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 3 Mar 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.
urpose: This study will be carried out to determine the effect of two different catheter covers on the comfort, satisfaction, pain level of the patient and the satisfaction of the nurse.
Materials and Methods: This study, which is planned as an open-label randomized controlled post-test study, will be carried out between December 2021 and February 2022. Data; Descriptive Properties will be collected with the Information Form and Visual Analog Scale (Visual Analog Scale-VAS). Data will be collected face to face by researchers.
Detailed description
Peripheral venous catheter (PVK) is applied to patients who apply to the hospital due to outpatient chemotherapy and need to receive treatment by intravenous route. This application is carried out by nurses. During their education, nurses receive theoretical and practical training on PVC applications. Nurses; They are the primary health professionals who are responsible for determining the PVC site, deciding on the catheter number to be used, applying the correct technique, performing the recommended intravenous (IV) interventions, following the complications that may develop by performing the necessary controls, ensuring the continuity of the application and providing catheter care.
The effective application of interventions such as transfusion of intravenous fluids, chemotherapy drugs, blood and blood products, and total parenteral feeding in cancer patients is provided by PVK. The application of PVC is a necessity for the treatment of the individual receiving treatment and may cause pain, deterioration in comfort and dissatisfaction. Although the widespread use of peripheral venous catheters provides great benefits, it has been reported that undesirable events such as phlebitis, infiltration, obstruction, leakage, and rarely infection occur when applied incorrectly and inadequately. In order for peripheral venous catheters to be used effectively in treatment, it is important to fix them with the correct technique. Detection becomes more important in the use of chemotherapy agents. The patches used for fixation adhere to the glove and are difficult to remove from the patient's skin. Therefore, both the nurse and the patient feel discomfort. For this reason, it would be appropriate to use a material that can be easily torn off with a glove, does not adhere to the glove, and fixes the patient's catheter well. This product should also be able to be easily removed without harming the patient's skin.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| masking tape group | Experimental | Other: Masking tapeMasking tape will be used |
| standard catheter dressing group | No intervention | –Medical plaster to be used (It is routine practice in the clinic.) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being between the ages of 18-65
- Being open to communication and cooperation
- Being conscious and able to answer questions
- Volunteering for research
- Being receiving chemotherapy treatment with a peripheral venous catheter
Key exclusion criteria (3 listed)
- Having a disease that may affect the ability to make decisions (dementia, psychological disorders, etc.)
- Having sensory losses such as vision and hearing
- Being in terminal period
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 |
|---|---|---|
| Masking tapeIV catheters will be fixed with masking tape | Other | masking tape group |
Primary outcome
Pain level
Time frame: a week
To be evaluated with "Visual analog scale"
Patient comfort
Time frame: a week
To be evaluated with "Visual analog scale"
Nurse's practice satisfaction
Time frame: a week
To be evaluated with "Visual analog scale"
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 2 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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 Masking tape in people with Personal Satisfaction and Pain, run by Necmettin Erbakan 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 5 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 2 Feb 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 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?
Pain level (time frame: a week). The study lists 3 primary outcomes in all. 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 2 Feb 2023.