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NCT Number: NCT05769647

Effect of Two Different Methods 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.

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Key information

Conditions

Pain Anxiety Disorders Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University, Konya, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2023
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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