The Peripheral Intravenous Catheterisation

NCT03945929 | Completed

• 1 other identifier: 18/7
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pain Associated With The Peripheral Intravenous Catheterisation

  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.

  1-2 minute

Study Arms (3)

Distraction1 group

EXPERIMENTAL

Distraction-1 Group (Cards containing optical illusion pictures)

Behavioral: Distraction

Control

NO INTERVENTION

Control

Distraction 2 group

EXPERIMENTAL

Distraction-2 Group

Behavioral: Distraction

Interventions

Distraction BEHAVIORAL

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.

Distraction 2 group; Distraction1 group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

Study Sites (1)

Ayla Demirtas

Ankara, 06018, Turkey (Türkiye)

Location

Related Publications (1)

• Basak T, Duman S, Demirtas A. Distraction-based relief of pain associated with peripheral intravenous catheterisation in adults: a randomised controlled trial. J Clin Nurs. 2020 Mar;29(5-6):770-777. doi: 10.1111/jocn.15131. Epub 2019 Dec 16.

  PMID: 31793099 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Osteogenesis, Distraction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bone Lengthening; Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• University of Health Sciences Gulhane Faculty of Nursing

  University of Health Sciences Ankara/Turkey

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 10, 2019
• Study Start: January 18, 2018
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)