NCT06835712

Brief Summary

Aim: The aim of the present study was to examine the effect of virtual reality and guided imagery to reduce pain during peripheral intravenous catheterization procedures in adults.Methods: The study will include 90 adults who were randomly selected between February and March 2025. One application group (n=30) will receive a virtual reality glasses application; the other application group (n=30) will receive a guided imagery application. The applications to the site of the peripheral intravenous catheterization will last two minutes. The control group (n=30) will receive the standard peripheral intravenous catheterization application procedure. The groups' level of pain during catheterization will be assessed using a visual analog scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 8, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

February 20, 2025

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

28 days

First QC Date

February 8, 2025

Last Update Submit

April 28, 2025

Conditions

Keywords

virtual realityguided imagerypain managementperipheral intravenous catheterization

Outcome Measures

Primary Outcomes (3)

  • procedure duration in sec

    In the stages of the peripheral intravenous catheterization intervention of individuals in the application and control groups, a chronometer will start immediately after an automatic tourniquet is attached to the patient's arm. After catheterization was completed successfully, the chronometer was stopped, and the procedure duration was recorded in the form of seconds on the data collection form.

    during the intervention/procedure

  • pain intensity in mm

    A 10-cm vertical VAS was used to evaluate the severity of pain felt by the individuals during the procedure. The lowest score that can be obtained from the scale is 0 and the highest score is 10 cm (100 mm). Pain severity was evaluated in millimeters

    during the intervention/procedure

  • procedure satisfaction in mm

    A scale between 1 and 10 will be used to evaluate the patients' satisfaction levels with the procedure. "1" on this scale indicates the least satisfaction level, and "10" indicates the highest satisfaction level. Patients will be asked to mark their level.

    during the intervention/procedure

Study Arms (3)

The virtual reality group

EXPERIMENTAL

During peripheral intravenous catheterization, virtual reality headset (Oculus Go) will be worn. Because the headset is reusable, attention will be paid to disinfecting them before and after each use.

Other: The guided imagery

The guided imagery group

EXPERIMENTAL

During peripheral intravenous catheterization, an audio clip Mp3 player and headphones will be worn. Since these headphones are reusable, they will be disinfected before and after each use.

Other: The virtual reality

The control group

EXPERIMENTAL

No intervention will perform on the control group before the peripheral intravenous catheterization procedure, and the standard peripheral intravenous catheterization procedure will perform.

Other: The virtual realityOther: The guided imagery

Interventions

During the PIK application, 3D visual and audio videos of the beach will be played with an Oculus Go brand virtual reality (VR) headset until the procedure is completed. The video that starts at the beginning of the procedure is planned to last approximately 2-3 minutes during the application. During this time, patients will be asked to close their eyes and take a comfortable position. The VR headset will be disinfected after each application and used on the other patient.

The control groupThe guided imagery group

Patients in this group will be played an audio clip that helps them imagine walking on a beach and gives instructions during the walk until the procedure is completed, using an MP3 player and headphones. The audio clip aims to activate the imagination of patients by allowing them to use their senses. For example, the temperature of the sun (feeling), the texture of the sand (touching), the color of the sea (seeing), the sound of the waves (hearing), and the smell of the sea (smell) are some examples of this. The audio clip will be voiced by a professional voice artist with good diction. It is planned that the audio clip will be played for approximately 2-3 minutes during the application. During this time, patients will be allowed to close their eyes and take a comfortable position. The headphones of the MP3 player will be disinfected after each application and used on the other patient.

The control groupThe virtual reality group

Eligibility Criteria

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

You may qualify if:

  • Being in accordance with time and place
  • Being in no sensory problems
  • Being aged between 18 and 65 years
  • Being able to evaluate the visual analog scale correctly
  • Participating voluntarily in the research.

You may not qualify if:

  • Not participating voluntarily in the research
  • Having a vision or hearing problem
  • Having any illness which could affect pain perception, such as sensorymotor disorder, diabetes, peripheral vascular diseases or peripheral neuropathy
  • Having phlebitis, scar tissue, dermatitis, an incision or findings of infection at the place where the intervention was to be performed
  • Having taken an analgesic (within the previous six hours) or an anesthetic agent before the peripheral intravenous catheterization procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University

Izmir, Cigli, 35640, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2025

First Posted

February 19, 2025

Study Start

February 20, 2025

Primary Completion

March 20, 2025

Study Completion

March 30, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations