Effect of Two Different Methods on Pain and Anxiety

Effect of Two Different Methods Applied During Peripheral Intravenous Catheter Placement on Pain and Anxiety

The aim of this study is to determine the effect of virtual reality glasses and ball squeezing method used during peripheral intravenous catheter placement on pain and anxiety.The hypotheses of this research are that virtual reality glasses and a stress ball reduces pain and anxiety.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: Virtual Reality Glasses; Device: Stress Ball

Detailed Description

This study was designed as a pretest-posttest regular parallel group, randomized controlled experimental. The research will be carried out in the general surgery clinic of Necmettin Erbakan University Meram Medical Faculty Hospital. Patients will be randomly assigned to three groups: ball squeezing (37), virtual reality glasses (37) and control group (37). For Virtual Reality Glasses Group: The video containing the nature walk will be watched by virtual reality. 3 minutes after the individual starts watching the video, the IV catheter insertion attempt will be performed while continuing to watch the video. For Ball Squeezing Group: Patients will be given a ball and instructed to tighten and loosen with their free hand during intravenöz catheter placement. The intravenöz catheter insertion attempt will be made while the patient continues to squeeze the ball. For Control Group: No application will be made during intravenous catheter placement in the control group.The primary outcome of this study was to determine the patients' pain scores during the peripheral venous cannula insertion process.The secondary outcomes of the study were to determine the patients' anxiety levels.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42040
    • Turkey, Necmettin Erbakan University
  • Konya, Turkey, 42040
    • Necmettin Erbakan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Admission to the General Surgery clinic.
• No verbal, perceptual and visual communication problems,
• Being between 18 - 65 years old,
• Being literate,
• Volunteer to participate in the research,
• Not using drugs that will create a chronic analgesic effect,
• Absence of chronic or acute pain,
• No intervention in the last month in the vein where an IV catheter was placed.
• The absence of scar tissue and infection in the areas to be used for IV catheter placement,
• It was determined as not having a disease (such as neuropathy) that would cause problems in feeling pain.

Exclusion Criteria:

• The individual's desire to leave the study,
• Inability to perform the ball squeezing motion,
• Feeling unwell during IV catheter placement (such as dizziness, palpitations),
• During use of VR, the patient experiences symptoms such as nausea and dizziness,
• Using sedatives or alcohol,

Termination criteria

• Failure of PIV catheter placement,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Glasses Group; "Volunteer Information and Approval Form" will be filled.; Physician request, the name and surname of the individual will be checked.; Patient Information Form and State Anxiety Scale will be filled.; The video containing the nature walk will be watched by virtual reality. 3 minutes after the individual starts watching the video, the IV catheter insertion attempt will be performed while continuing to watch the video.; Visual Pain Scale and State Anxiety Scale will be filled within one minute after intravenous catheter placement is completed.	Device: Virtual Reality Glasses; 3 minutes after the individual starts watching the video, the IV catheter insertion attempt will be performed while continuing to watch the video.
Experimental: Ball Squeezing Group; "Volunteer Information and Approval Form" will be filled.; Physician request, the name and surname of the individual will be checked.; Patient Information Form and State Anxiety Scale will be filled.; Patients will be given a ball and instructed to tighten and loosen with their free hand during IVC placement. The IV catheter insertion attempt will be made while the patient continues to squeeze the ball.; Visual Pain Scale and State Anxiety Scale will be filled within one minute after intravenous catheter placement is completed.	Device: Stress Ball; Patients will be given a ball and instructed to tighten and loosen with their free hand during IVC placement. The patient will continue to squeeze the ball throughout the IV catheter insertion attempt.
No Intervention: Control Group: "Volunteer Information and Approval Form" will be filled.; Physician request, the name and surname of the individual will be checked.; Patient Information Form and State Anxiety Scale will be filled.; An intravenous catheter will be placed.; Visual Pain Scale and State Anxiety Scale will be filled within one minute after intravenous catheter placement is completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain evaluated using the Visual Pain Scale	The Visual Pain Scale is mostly a 10 cm/100 mm long horizontal or vertical line starting with "No pain" and ending with "Unbearable pain". While measuring, there is no pain at one end, very severe or unbearable pain is written on the other end, and the patient marks his or her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.	It will be applied within 1 minute after the virtual reality reality glasses and ball squeezing processes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety evaluated using the State Anxiety Scale	In the State Anxiety Inventory, the individual evaluates how he or she feels "at the moment" and according to the severity of the emotions or behaviors expressed in the items (1) "never", (2) "a little", (3) "a lot" and (4) "a lot". are asked to choose one of the statements "completely". The highest score of 4 is given for choosing the phrase "completely", and the lowest score is 1 for choosing the phrase "not at all". The lowest total score that can be obtained from the State Anxiety Scale is 20, and the highest total score is 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.	It will be applied before and afte within 1 minute after the virtual reality reality glasses and ball squeezing processes.

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University
• Investigators: Principal Investigator: Serpil SU, Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2023
• Primary Completion (Actual): August 4, 2023
• Study Completion (Actual): August 4, 2023

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Peripheral Intravenous Catheter Insertion
• Other Study ID Numbers: Nec EU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No