Effect of Two Different Methods on Pain and Anxiety

NCT05769647 | Completed DMC

• 1 other identifier: Nec EU
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pain

Keywords

Peripheral Intravenous Catheter Insertion; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anxiety evaluated using the State Anxiety Scale

  It will be applied before and afte within 1 minute after the virtual reality reality glasses and ball squeezing processes.

Study Arms (3)

Virtual Reality Glasses Group

EXPERIMENTAL

* "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

Ball Squeezing Group

EXPERIMENTAL

* "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

Control Group:

NO INTERVENTION

* "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.

Interventions

Virtual Reality Glasses DEVICE

3 minutes after the individual starts watching the video, the IV catheter insertion attempt will be performed while continuing to watch the video.

Virtual Reality Glasses Group

Stress Ball DEVICE

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.

Ball Squeezing Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (2)

Necmettin Erbakan University

Konya, 42040, Turkey (Türkiye)

Location

Turkey, Necmettin Erbakan University

Konya, 42040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Serpil SU

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients will be informed about the study and their consent will be obtained without explaining which group they are in. Since the researcher manages the implementation process of the study, researcher blinding cannot be done. In addition, it will be ensured that the researcher learns which group the patients are in after the patients accept to participate in the study. Thus, the internal validity of the research will be ensured. Since data is collected from the patients in the sample group at the time of admission to the ward, interaction between patients will be prevented. At the same time, blind technique will be applied in terms of statistical analysis in the research. The data will be recorded on the computer by the researcher without using the expression of experimental and control groups, and data analysis will be done by another statistician other than the person who made the randomization.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: July 15, 2023
• Primary Completion: August 4, 2023
• Study Completion: August 4, 2023
• Last Updated: February 14, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)