Use of Hand Extension Rubber During Intravenous Catheter... | NCT07659015

Studies
Use of Hand Extension Rubber During Intravenous Catheter Placement

NCT07659015

Sponsor

Necmettin Erbakan University

Status

Recruiting

Last Update Posted

Jun 22, 2026Actual

Enrollment

114Estimated

Phase

Not Applicable

Conditions

Pain
Anxiety
Satisfaction

Interventions

Hand Extension Rubber

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2026Estimated

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Aug 1, 2026Estimated

First Submitted Date

Jun 9, 2026

First Submission Date that Met QC Criteria

Jun 15, 2026

First Posted Date

Jun 22, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2026

Last Update Posted Date

Jun 22, 2026Actual

Name	Class
Konya Necmettin Erbakan Üniversitesi	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to investigate the effect of a hand extension rubber used in patients with peripheral intravenous catheters on pain, anxiety, and satisfaction.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

114Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
İntervention	Experimental	Hand Extension Rubber will be used for distraction	Other: Hand Extension Rubber
control	No Intervention	No intervention group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hand Extension Rubber	Other	Hand Extension Rubber will be used for distraction while peripheral IV catheher placement.	İntervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain associated with PIC procedure (using VAS-visual analogue scale)	Pain associated with PIC procedure	after the PIC implementation

Secondary Outcomes

Measure	Description	Time Frame
satisfaction associated with PIC procedure (using State-Trait Anxiety Inventory)	satisfaction	after the PIC implementation
anxiety associated with PIC procedure (using a five likert type quesiton-)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gülden Basit	Contact	+90 332 320 40 29		guldenbasit@gmail.com
Melike Kışla	Contact			melikeksla@gmail.com

Overall Officials

Name	Affiliation	Role
Melike Kışla	Master student	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Necmettin Erbakan University	Recruiting	Konya	Meram		Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D001008	Anxiety Disorders
D010549	Personal Satisfaction

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders

Browse Leaves

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Browse Branches

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