TourniquetsCATHETERNCT06862921
Effects of Dıfferent Tournıques and Posıtıons on Paın, Anxıety Levels and Applıcatıon Success in Perıpheral Intravenous Catheter Applıcatıon: a Randomızed Controlled Study
A study of Tourniquets and INTRAVENOUS CATHETER APPLICATION, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study was to investigate the effect of different tourniquet and position on pain, anxiety level and success of peripheral intravenous catheter (PIC) application. Design: Randomized controlled experimental design. Read more about this study
- Who is it for?
- Ages 18 to 64 weeksHealthy volunteers can take part
- Conditions the study is for
- Tourniquets, INTRAVENOUS CATHETER APPLICATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Sep 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 to 64 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient
- Volunteering to participate in the research
- Be between the ages of 18-64,
- The planned length of hospitalization is not less than 96 hours.
Who cannot join
- In the patient
- <!-- -->
- Coagulation, hematologic and hydration problems
- Oncological, allergic diseases, any incision or scar tissue in the antecubital area, presence of complications due to a previously opened catheter, presence of pain, hematoma, ecchymosis in the application area, or presence of any other injection in the antecubital area on treatment days,
- The presence of an obstacle (such as mastectomy) in the arm to be treated.
- Expulsion criteria from the study:
Show all 10Show fewer
- <!-- -->
- Dislodgement of the peripheral intravenous catheter for any reason.
- Failure of peripheral intravenous catheter placement more than twice.
- Discharge of the patient from the hospital.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sancaktepe Martyr Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul, Istanbul, 34704
About this study
Aim:
The aim of this study was to investigate the effect of different tourniquet and position on pain, anxiety level and success of peripheral intravenous catheter (PIC) application.
Design:
Randomized controlled experimental design.
Read the detailed description
Aim:
The aim of this study was to investigate the effect of different tourniquet and position on pain, anxiety level and success of peripheral intravenous catheter (PIC) application.
Primary purpose:investigate the effect of different tourniquet and position on pain, Secondary purpose:investigate the effect of different tourniquet and position on anxiety level and success of peripheral intravenous catheter (PIC) application.
Design:
Randomized controlled experimental design.
Methods:
The randomized controlled experimental design study was conducted with 110 adult patients in the orthopedic department of a Training and Research Hospital between May 2024 and July 2024. Data were collected using the Patient Information Form, Visual Infusion Phlebitis Diagnostic Scale, Infiltration Scale, Visual Pain Scale, and Facial Anxiety Scale. PIC was applied to patients in the "Experimental Group 1" using a standard tourniquet in the supine position, to patients in the "Experimental Group 2" using a sphygmomanometer at 60 mmHg pressure in the fawler position, and to patients in the "Experimental Group 3" using a sphygmomanometer at 60 mmHg pressure in the supine position. In the control group, a peripheral intravenous catheter was applied in the fawler position using a standard tourniquet. Patients were asked to evaluate the level of pain and anxiety before and after the application. The patients were followed up for phlebitis and extravasation findings at eight-hour intervals after the application. Except for complications requiring removal of the peripheral intravenous catheter during follow-up, the PIC was removed 96 hours after application. The results were evaluated at 95% confidence intervals with a significance level of p ≤ 0.05.
- Conditions
- Tourniquets, INTRAVENOUS CATHETER APPLICATION
- Being tested
- Control
- Keywords
- Peripheral Catheterization; tourniquet; pain; anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
fawler position using a standard tourniquet
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | standard tourniquet in the supine position Receives: Other: Control |
| Experimental Group 2 | Experimental | sphygmomanometer at 60 mmHg pressure in the fawler position Receives: Other: Control |
| Experimental Group 3 | Experimental | sphygmomanometer at 60 mmHg pressure in the supine position Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Infusion Phlebitis Diagnostic Scale
This scale developed by Schultze and Gallant (2006) was published by the Infusion Nurses Society (2006) and is a widely used scale in the clinical evaluation of infusion phlebitis. Phlebitis assessment was evaluated by the investigator using the VIFFS once every eight hours until the PIC was removed and recorded on the patient follow-up form.
Measured: 3 month
Infiltration Scale (IS)
Infiltration Scale (IS): This scale was published by the Intravenous Nurses Association (2006) and its psychometric properties were evaluated by Groll et al. Infiltration assessment was evaluated by the investigator using the IS once every eight hours until the PIC was removed and recorded on the patient follow-up form
Measured: 3 month
Visual Pain Scale (VAS):
Visual Pain Scale (VAS): This scale was developed by Hayes and Patterson in 1921 and is used to assess pain intensity. Pain intensity is measured using a 10 cm visual scale; mean pain scores ranging from 0 to 10 are given. zero indicates the absence of pain, ten indicates the presence of severe pain. A VAS value of one to four indicates mild pain, five to six indicates moderate pain, and seven to ten indicates severe pain. The researcher asked the patient to indicate the severity of pain according to VAS before and after PIC placement and recorded the value on the patient follow-up form.
Measured: 3 month
Facial Anxiety Scale (FAS)
Facial Anxiety Scale (FAS): The Turkish validity and reliability of the scale developed by McKinley, Coote, and Stein-Parbury (2003) was performed by İyigün, Pazar, and Taştan (2016). The Face Anxiety Scale is 11 × 42 cm in size. It consists of five different facial expressions, the leftmost facial expression indicates the absence of anxiety, while the level of anxiety increases from left to right. The FAS is scored from zero to five from left to right, respectively. A score of three on this scale indicates moderate anxiety, while a score of four and above indicates high anxiety. In this scale, the patient evaluates his/her own anxiety (McKinley 2004). The researcher showed the scale to the patient before and after PIC placement and asked the patient to evaluate which facial expression corresponded to his/her anxiety level and recorded the result on the patient follow-up form.Application of research
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Jun 2024
- Primary completion1 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TourniquetsStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şerife Kelle Dikbaş, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862921
- Sponsor's protocol ID
- Uskudar University
- Other IDs
- Clinical Research Ethics Commi
- Acronym
- CATHETER
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Tran QK, Flanagan K, Fairchild M, Yardi I, Pourmand A. Nurses and Efficacy of Ultrasound-Guided Versus Traditional Venous Access: A Systemic Review and Meta-Analysis. J Emerg Nurs. 2022 Mar;48(2):145-158.e1. doi: 10.1016/j.jen.2021.12.003. Epub 2022 Feb 4.
PubMed 35125291Tran T, Lund SB, Nichols MD, Kummer T. Effect of two tourniquet techniques on peripheral intravenous cannulation success: A randomized controlled trial. Am J Emerg Med. 2019 Dec;37(12):2209-2214. doi: 10.1016/j.ajem.2019.03.034. Epub 2019 Mar 23.
PubMed 30948254
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dıfferent Tournıques and Posıtıons on Paın, Anxıety Levels and Applıcatıon Success in Perıpheral Intravenous Catheter Applıcatıon: a Randomızed Controlled Study
- ClinicalTrials.gov ID
- NCT06862921
- Acronym / sponsor ID
- CATHETER / Uskudar University
- Conditions
- Tourniquets, INTRAVENOUS CATHETER APPLICATION
- Keywords
- Peripheral Catheterization; tourniquet; pain; anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 6 Mar 2025 (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.
Aim:
The aim of this study was to investigate the effect of different tourniquet and position on pain, anxiety level and success of peripheral intravenous catheter (PIC) application.
Design:
Randomized controlled experimental design.
Detailed description
Aim:
The aim of this study was to investigate the effect of different tourniquet and position on pain, anxiety level and success of peripheral intravenous catheter (PIC) application.
Primary purpose:investigate the effect of different tourniquet and position on pain, Secondary purpose:investigate the effect of different tourniquet and position on anxiety level and success of peripheral intravenous catheter (PIC) application.
Design:
Randomized controlled experimental design.
Methods:
The randomized controlled experimental design study was conducted with 110 adult patients in the orthopedic department of a Training and Research Hospital between May 2024 and July 2024. Data were collected using the Patient Information Form, Visual Infusion Phlebitis Diagnostic Scale, Infiltration Scale, Visual Pain Scale, and Facial Anxiety Scale. PIC was applied to patients in the "Experimental Group 1" using a standard tourniquet in the supine position, to patients in the "Experimental Group 2" using a sphygmomanometer at 60 mmHg pressure in the fawler position, and to patients in the "Experimental Group 3" using a sphygmomanometer at 60 mmHg pressure in the supine position. In the control group, a peripheral intravenous catheter was applied in the fawler position using a standard tourniquet. Patients were asked to evaluate the level of pain and anxiety before and after the application. The patients were followed up for phlebitis and extravasation findings at eight-hour intervals after the application. Except for complications requiring removal of the peripheral intravenous catheter during follow-up, the PIC was removed 96 hours after application. The results were evaluated at 95% confidence intervals with a significance level of p ≤ 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Other: Controlstandard tourniquet in the supine position |
| Experimental Group 2 | Experimental | Other: Controlsphygmomanometer at 60 mmHg pressure in the fawler position |
| Experimental Group 3 | Experimental | Other: Controlsphygmomanometer at 60 mmHg pressure in the supine position |
Who may qualify
- Ages
- 18 to 64 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient
Key exclusion criteria (10 listed)
- In the patient
- <!-- -->
- <!-- -->
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 |
|---|---|---|
| Controlfawler position using a standard tourniquet | Other | Experimental Group 1, Experimental Group 2, Experimental Group 3 |
Primary outcome
Visual Infusion Phlebitis Diagnostic Scale
Time frame: 3 month
This scale developed by Schultze and Gallant (2006) was published by the Infusion Nurses Society (2006) and is a widely used scale in the clinical evaluation of infusion phlebitis. Phlebitis assessment was evaluated by the investigator using the VIFFS once every eight hours until the PIC was removed and recorded on the patient follow-up form.
Infiltration Scale (IS)
Time frame: 3 month
Infiltration Scale (IS): This scale was published by the Intravenous Nurses Association (2006) and its psychometric properties were evaluated by Groll et al. Infiltration assessment was evaluated by the investigator using the IS once every eight hours until the PIC was removed and recorded on the patient follow-up form
Visual Pain Scale (VAS):
Time frame: 3 month
Visual Pain Scale (VAS): This scale was developed by Hayes and Patterson in 1921 and is used to assess pain intensity. Pain intensity is measured using a 10 cm visual scale; mean pain scores ranging from 0 to 10 are given. zero indicates the absence of pain, ten indicates the presence of severe pain. A VAS value of one to four indicates mild pain, five to six indicates moderate pain, and seven to ten indicates severe pain. The researcher asked the patient to indicate the severity of pain according to VAS before and after PIC placement and recorded the value on the patient follow-up form.
Facial Anxiety Scale (FAS)
Time frame: 3 month
Facial Anxiety Scale (FAS): The Turkish validity and reliability of the scale developed by McKinley, Coote, and Stein-Parbury (2003) was performed by İyigün, Pazar, and Taştan (2016). The Face Anxiety Scale is 11 × 42 cm in size. It consists of five different facial expressions, the leftmost facial expression indicates the absence of anxiety, while the level of anxiety increases from left to right. The FAS is scored from zero to five from left to right, respectively. A score of three on this scale indicates moderate anxiety, while a score of four and above indicates high anxiety. In this scale, the patient evaluates his/her own anxiety (McKinley 2004). The researcher showed the scale to the patient before and after PIC placement and asked the patient to evaluate which facial expression corresponded to his/her anxiety level and recorded the result on the patient follow-up form.Application of research
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 6 Mar 2025.
- Background: PubMed 35125291Tran QK, Flanagan K, Fairchild M, Yardi I, Pourmand A. Nurses and Efficacy of Ultrasound-Guided Versus Traditional Venous Access: A Systemic Review and Meta-Analysis. J Emerg Nurs. 2022 Mar;48(2):145-158.e1. doi: 10.1016/j.jen.2021.12.003. Epub 2022 Feb 4.
- Background: PubMed 30948254Tran T, Lund SB, Nichols MD, Kummer T. Effect of two tourniquet techniques on peripheral intravenous cannulation success: A randomized controlled trial. Am J Emerg Med. 2019 Dec;37(12):2209-2214. doi: 10.1016/j.ajem.2019.03.034. Epub 2019 Mar 23.
- Individual participant dataSharing planned: Yes
Related trials for Tourniquets
Enrolling by invitation
Reducing Blood Loss During Myomectomy by Comparing Local Epinephrine and Uterine Artery Tourniquet During Procedure
Local Epinephrine in Myomectomy
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Not yet recruiting
Healthy Adults Aged 18-55, Three Ukrainian Windlass Tourniquets (SICH, DNIPRO GEN 2, PULS) Compared With CAT Gen 7, and Complete Limb Arterial Occlusion Confirmed by Doppler.
Hemorrhage, Healthy Volunteers
Not yet recruiting
Wide-Awake Local Anesthesia No-Tourniquet (WALANT) Procedures
Hand Injuries and Disorders
Not yet recruiting
Effect of Tourniquet Use on the Pivot Shift Test
Anterior Cruciate Ligament Injury
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 of Tourniquets and INTRAVENOUS CATHETER APPLICATION, run by Istanbul University - Cerrahpasa 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 10 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 6 Mar 2025. 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?
Visual Infusion Phlebitis Diagnostic Scale (time frame: 3 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06862921, which also lists 2 linked publications.
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 6 Mar 2025.