Effect of Two Different Methods on Pain and Anxiety

February 12, 2024 updated by: Serpil SU, Necmettin Erbakan University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain evaluated using the Visual Pain Scale
Time Frame: It will be applied within 1 minute after the virtual reality reality glasses and ball squeezing processes.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anxiety evaluated using the State Anxiety Scale
Time Frame: It will be applied before and afte within 1 minute after the virtual reality reality glasses and ball squeezing processes.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Necmettin Erbakan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Serpil SU, Necmettin Erbakan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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