Peripheral Intravenous PhlebitisNCT07820956
Ice Application for Oxacillin-Related Phlebitis and Pain
A study testing Ice Application and Room-Temperature Water-Bag Application in people with Peripheral Intravenous Phlebitis and Injection Site Pain, run by Central Taiwan University of Science and Technology at 1 site in Taiwan.
Trial summary
This randomized controlled trial evaluated whether ice application could reduce pain and peripheral intravenous phlebitis associated with oxacillin administration. Hospitalized patients receiving intravenous oxacillin were assigned to either an ice application group or a control group. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Peripheral Intravenous Phlebitis, Injection Site Pain, Pain
- What is being tested?
- Ice Application and Room-Temperature Water-Bag Application
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Apr 2022to 31 Dec 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 20 to 60 years. Conscious and able to participate in the study. Intravenous injection site located on either hand. Receiving a single antibiotic medication during the study. Eligible regardless of sex or medical diagnosis.
Who cannot join
- Dementia. Psychiatric disorders. Skin rash at the study site. Purpura. Pregnancy. Current oral corticosteroid use. Hemodialysis. Administration of a second medication or an injection containing two or more medications during the study.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ice Application on Reducing Peripheral Vascular Phlebitis and Pain After Oxacillin Injection: A Randomized Single-Blind Controlled Trial
This randomized controlled trial evaluated whether ice application could reduce pain and peripheral intravenous phlebitis associated with oxacillin administration. Hospitalized patients receiving intravenous oxacillin were assigned to either an ice application group or a control group. In the intervention group, ice was applied to the area around the peripheral intravenous catheter before oxacillin administration. In the control group, a room-temperature water bag was applied in the same manner. Pain after oxacillin administration and signs of phlebitis at the intravenous catheter site were assessed and compared between the two groups. The study aimed to determine whether ice application could provide a simple, non-pharmacological approach to reducing oxacillin-related pain and phlebitis.
- Conditions
- Peripheral Intravenous Phlebitis, Injection Site Pain, Pain
- Being tested
- Ice Application, Room-Temperature Water-Bag Application
- Keywords
- Oxacillin, Ice Application, Peripheral Intravenous Catheter, Phlebitis, Pain, Cryotherapy
- Medical subject headings
- Pain, Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice ApplicationOther
Ice was applied around the peripheral intravenous catheter site before intravenous oxacillin administration. The intervention was intended to reduce pain associated with oxacillin administration and the occurrence of peripheral intravenous phlebitis.
Room-Temperature Water-Bag ApplicationOther
A room-temperature water bag was applied around the peripheral intravenous catheter site before intravenous oxacillin administration as the control condition.
| Study group | Role | What they receive |
|---|---|---|
| Ice Application Group | Experimental | Participants assigned to this group received ice application around the peripheral intravenous catheter site before intravenous oxacillin administration. Receives: Other: Ice Application |
| Room-Temperature Water-Bag Control Group | Active comparator | Participants assigned to this group received a room-temperature water-bag application around the peripheral intravenous catheter site before intravenous oxacillin administration. Receives: Other: Room-Temperature Water-Bag Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity After Intravenous Oxacillin Administration
Pain intensity associated with intravenous oxacillin administration was assessed repeatedly after oxacillin administration across nine 8-hour intervals during the 72-hour observation period. Higher pain scores indicated greater pain intensity.
Measured: Up to 72 hours after intravenous oxacillin administration
Pain Intensity After Intravenous Oxacillin Administration
Pain intensity associated with intravenous oxacillin administration was assessed using a numerical rating scale, with higher scores indicating greater pain. Pain was assessed repeatedly after oxacillin administration across nine 8-hour intervals during the 72-hour observation period.
Measured: From 1 to 72 hours after initiation of the study intervention, assessed at 1-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, and 65-72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start7 Apr 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Intravenous PhlebitisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Taiwan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuan-Yu Lin, Central Taiwan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820956
- Sponsor's protocol ID
- FYH-IRB-111004
- Other IDs
- 111004
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ice Application on Reducing Peripheral Vascular Phlebitis and Pain After Oxacillin Injection: A Randomized Single-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07820956
- Acronym / sponsor ID
- FYH-IRB-111004
- Conditions
- Peripheral Intravenous Phlebitis, Injection Site Pain, Pain
- Keywords
- Oxacillin, Ice Application, Peripheral Intravenous Catheter, Phlebitis, Pain, Cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Central Taiwan University of Science and TechnologyUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 Sep 2026 (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 randomized controlled trial evaluated whether ice application could reduce pain and peripheral intravenous phlebitis associated with oxacillin administration. Hospitalized patients receiving intravenous oxacillin were assigned to either an ice application group or a control group. In the intervention group, ice was applied to the area around the peripheral intravenous catheter before oxacillin administration. In the control group, a room-temperature water bag was applied in the same manner. Pain after oxacillin administration and signs of phlebitis at the intravenous catheter site were assessed and compared between the two groups. The study aimed to determine whether ice application could provide a simple, non-pharmacological approach to reducing oxacillin-related pain and phlebitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ice Application Group | Experimental | Other: Ice ApplicationParticipants assigned to this group received ice application around the peripheral intravenous catheter site before intravenous oxacillin administration. |
| Room-Temperature Water-Bag Control Group | Active comparator | Other: Room-Temperature Water-Bag ApplicationParticipants assigned to this group received a room-temperature water-bag application around the peripheral intravenous catheter site before intravenous oxacillin administration. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults aged 20 to 60 years. Conscious and able to participate in the study. Intravenous injection site located on either hand. Receiving a single antibiotic medication during the study. Eligible regardless of sex or medical diagnosis.
Key exclusion criteria (2 listed)
- Dementia. Psychiatric disorders. Skin rash at the study site. Purpura. Pregnancy. Current oral corticosteroid use. Hemodialysis. Administration of a second medication or an injection containing two or more medications during the study.
- -
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 |
|---|---|---|
| Ice ApplicationIce was applied around the peripheral intravenous catheter site before intravenous oxacillin administration. The intervention was intended to reduce pain associated with oxacillin administration and the occurrence of peripheral intravenous phlebitis. | Other | Ice Application Group |
| Room-Temperature Water-Bag ApplicationA room-temperature water bag was applied around the peripheral intravenous catheter site before intravenous oxacillin administration as the control condition. | Other | Room-Temperature Water-Bag Control Group |
Primary outcome
Pain Intensity After Intravenous Oxacillin Administration
Time frame: Up to 72 hours after intravenous oxacillin administration
Pain intensity associated with intravenous oxacillin administration was assessed repeatedly after oxacillin administration across nine 8-hour intervals during the 72-hour observation period. Higher pain scores indicated greater pain intensity.
Pain Intensity After Intravenous Oxacillin Administration
Time frame: From 1 to 72 hours after initiation of the study intervention, assessed at 1-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, and 65-72 hours.
Pain intensity associated with intravenous oxacillin administration was assessed using a numerical rating scale, with higher scores indicating greater pain. Pain was assessed repeatedly after oxacillin administration across nine 8-hour intervals during the 72-hour observation period.
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 15 Sep 2026.
- 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 Ice Application and Room-Temperature Water-Bag Application in people with Peripheral Intravenous Phlebitis and Injection Site Pain, run by Central Taiwan University of Science and Technology at 1 site in Taiwan.
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 1 inclusion and 2 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 15 Sep 2026. 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 Taiwan. 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 Intensity After Intravenous Oxacillin Administration (time frame: Up to 72 hours after intravenous oxacillin administration). The study lists 2 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 15 Sep 2026.