- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07659015
Use of Hand Extension Rubber During Intravenous Catheter Placement (PIC)
June 15, 2026 updated by: Gulden Basit, Necmettin Erbakan University
The Effect of Hand Extension Rubber Used in Patients With Peripheral Intravenous Catheter Insertion on Pain, Anxiety and Satisfaction: A Randomized Controlled Trial
The study aims to investigate the effect of a hand extension rubber used in patients with peripheral intravenous catheters on pain, anxiety, and satisfaction.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
While the use of non-pharmacological methods to reduce pain and anxiety levels and increase satisfaction during peripheral intravenous catheterization has gained importance in recent years, studies on techniques that are easy to implement, low-cost, and proven to be effective-particularly in adults-remain limited.
It is believed that the hand extension rubber has the potential to reduce pain and anxiety as a distraction method, thereby increasing patient satisfaction.
The findings will enhance nurses' adherence to evidence-based practices and improve the quality of patient care.
This study holds unique value as it is the first research in Turkey to address this method in adult individuals.
Study Type
Interventional
Enrollment (Estimated)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gülden Basit
- Phone Number: +90 332 320 40 29
- Email: guldenbasit@gmail.com
Study Contact Backup
- Name: Melike Kışla
- Email: melikeksla@gmail.com
Study Locations
-
-
Meram
-
Konya, Meram, Turkey (Türkiye)
- Recruiting
- Necmettin Erbakan University
-
Contact:
- Gülden Basit, Assoc. Prof.
- Phone Number: +90 332 320 40 29
- Email: guldenbasit@gmail.com
-
Contact:
- Melike Kışla, Msc student
- Email: melikeksla@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Volunteers willing to participate in the study
- Patients aged 18-65
- Patients who are alert and able to communicate verbally in Turkish
- Patients assigned to the green zone during triage
- Patients suitable for PICC placement in the left cephalic and basilic veins
- Patients who are right-handed
- Patients with a VAS pain score of 0 prior to the PIC procedure
Exclusion Criteria:
- Patients with acute or chronic pain
- Patients with conditions that cause limited mobility, such as muscle disorders or grip dysfunction
- Patients with peripheral neuropathy, arteriovenous fistula, or bilateral mastectomy
- Patients with a psychiatric diagnosis (as self-reported)
- Patients with communication impairments (hearing, speech, and vision)
- Patients with a history of negative PIC procedure experiences
Terminating Criteria:
- Participants wishing to withdraw from the study at any stage after giving their consent
- Failure of the PIC procedure
- Failure to use the hand extension band until the end of the procedure
- Occurrence of complications related to the PIC procedure during the procedure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: İntervention
Hand Extension Rubber will be used for distraction
|
Hand Extension Rubber will be used for distraction while peripheral IV catheher placement.
|
|
No Intervention: control
No intervention group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain associated with PIC procedure (using VAS-visual analogue scale)
Time Frame: after the PIC implementation
|
Pain associated with PIC procedure
|
after the PIC implementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
satisfaction associated with PIC procedure (using State-Trait Anxiety Inventory)
Time Frame: after the PIC implementation
|
satisfaction
|
after the PIC implementation
|
|
anxiety associated with PIC procedure (using a five likert type quesiton-)
Time Frame: after the PIC implementation
|
anxiety
|
after the PIC implementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Melike Kışla, Master student
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 15, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
June 9, 2026
First Submitted That Met QC Criteria
June 15, 2026
First Posted (Actual)
June 22, 2026
Study Record Updates
Last Update Posted (Actual)
June 22, 2026
Last Update Submitted That Met QC Criteria
June 15, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GB-MK-2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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