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The Peripheral Intravenous Catheterisation

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ClinicalTrials.gov Identifier: NCT03945929
Recruitment Status : Completed
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Ayla Demirtas, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

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 Intervention/treatment Phase
Pain Behavioral: Distraction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: The researcher, who did not know which patient was in which group, collected the data on the assessment of PIC procedure-associated pain and satisfaction levels immediately after PIC insertion using face-to-face interviews.
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 18, 2018
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Arm Intervention/treatment
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.


No Intervention: Control
Control
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.





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.



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Ages Eligible for Study:   18 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945929


Locations
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Turkey
Ayla Demirtas
Ankara, Turkey, 06018
Sponsors and Collaborators
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Investigators
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Study Chair: University of Health Sciences Gulhane Faculty of Nursing University of Health Sciences Ankara/Turkey
  Study Documents (Full-Text)

Documents provided by Ayla Demirtas, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi:
Study Protocol  [PDF] September 16, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ayla Demirtas, Assistant Professor, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
ClinicalTrials.gov Identifier: NCT03945929    
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No