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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

The Peripheral Intravenous Catheterisation

Clinicaltrials.gov identifier NCT03945929

Recruitment Status Completed

First Posted May 10, 2019

Last update posted May 10, 2019

Study Description

Brief summary:

Pain management during medical care is considered to be a basic human right and also affects patient satisfaction. In addition, effective management of acute pain contributes to improved patient outcomes. Patient satisfaction is a subjective state that indicates whether the healthcare provided has met the patient's needs and expectations. Many nurse theorists, including Florence Nightingale, have expressed the importance of providing comfort and relief for patients. In fact, comfort has been a crucial aspect of patient care since Nightingale's days, and has been considered an indispensable constituent of integrated nursing care. Studies to improve comfort may contribute to improving individuals' health outcomes, enforcing health-improvement behaviors, and improving healthcare quality as well as satisfaction and contentment of the individual and the nurse in the process of administering healthcare. In the literature, although the efficacy of various pharmacological methods for reducing pain associated with the insertion of PIC has been evaluated in adults, studies on nonpharmacological methods are limited. However, most of the studies were performed in healthy adults. Easy, inexpensive, and fast methods with unlikely side effects are needed to control pain and distress due to the PIC insertion in adults. Therefore, this study was performed to evaluate the effectiveness of distraction methods.

  • Condition or Disease:Pain
  • Intervention/Treatment: Behavioral: Distraction
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 120 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Investigator)
  • Primary Purpose: Supportive Care
  • Official Title: Can We Alleviate Pain Associated With The Peripheral Intravenous Catheterisation By Using Distraction Methods in Adults: A Randomised Controlled Trial
  • Actual Study Start Date: January 2018
  • Actual Primary Completion Date: April 2018
  • Actual Study Completion Date: April 2018
Arms and interventions
Arm Intervention/treatment
Experimental: Distraction 2 group
Distraction-2 Group
Behavioral: Distraction
Distraction-1 Group: Cards containing approximately six optical illusion pictures were shown to the patients and as a method of distraction during the PIC insertion procedure they were asked what they saw in these cards. Distraction-2 Group: Underwater 3D audial videos were played with visual reality (VR) goggles during PIC insertion until the procedure was completed.
Experimental: Distraction1 group
Distraction-1 Group (Cards containing optical illusion pictures)
Behavioral: Distraction
Distraction-1 Group: Cards containing approximately six optical illusion pictures were shown to the patients and as a method of distraction during the PIC insertion procedure they were asked what they saw in these cards. Distraction-2 Group: Underwater 3D audial videos were played with visual reality (VR) goggles during PIC insertion until the procedure was completed.
Outcome Measures
  • Primary Outcome Measures: 1. Pain Associated With The Peripheral Intravenous Catheterisation [ Time Frame: 1-2 minute ]
    Visual Analog Scale was used to evaluate pain caused by needle insertion. In the Visual Analog Scale of 10 cm length, "0" indicated no pain, and "10" indicated the severest pain.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Patients who ranked 4 (less urgent) and 5 (non-urgent) based on Canadian Emergency
Department Triage

- Patients who had no visual, audial, or lingual disabilities, and no mental disorder.

Exclusion Criteria:

- Patients who planned to have PIC insertion and were suitable for having a peripheral
intravenous catheter insertion at their antecubital location using 20 Gauge (pink)
cannula were eligible.

- Patients who refused to participate in the study,

- Patients who were not eligible for a 20 G peripheral intravenous catheter insertion,

- Patients who could not be inserted a peripheral intravenous catheter at the first time

Contacts and Locations
Contacts
Locations

Turkey
Ayla Demirtas
Ankara

Sponsors and Collaborators

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Investigators

Study Chair: University of Health Sciences Gulhane Faculty of Nursing University of Health Sciences Ankara/Turkey

More Information
  • Responsible Party: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
  • ClinicalTrials.gov Identifier: NCT03945929 History of Changes
  • Other Study ID Numbers: 18/7
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: May 10, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No