NCT07659015

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jun 2026

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 9, 2026

Last Update Submit

June 15, 2026

Conditions

Keywords

NursingPeripheral intravenous catheterPICPainAnxietySatisfaction

Outcome Measures

Primary Outcomes (1)

  • Pain associated with PIC procedure (using VAS-visual analogue scale)

    Pain associated with PIC procedure

    after the PIC implementation

Secondary Outcomes (2)

  • satisfaction associated with PIC procedure (using State-Trait Anxiety Inventory)

    after the PIC implementation

  • anxiety associated with PIC procedure (using a five likert type quesiton-)

    after the PIC implementation

Study Arms (2)

İntervention

EXPERIMENTAL

Hand Extension Rubber will be used for distraction

Other: Hand Extension Rubber

control

NO INTERVENTION

No intervention group

Interventions

Hand Extension Rubber will be used for distraction while peripheral IV catheher placement.

İntervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

PainAnxiety DisordersPersonal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavior

Study Officials

  • Melike Kışla

    Master student

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melike Kışla

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the study, researcher and participant blinding will not be possible. However, the statistician conducting the data analysis will be blinded.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: It is designed as a pre-test-post-test randomized controlled experimental study with parallel groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Ph.D.

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 22, 2026

Study Start

June 15, 2026

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

June 22, 2026

Record last verified: 2026-06

Locations