Effect of Two Different Methods on Pain and Anxiety

NCT ID: NCT05769647

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-15

Study Completion Date

2023-08-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual Reality Glasses

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

Stress Ball

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

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Serpil SU

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serpil SU

Role: PRINCIPAL_INVESTIGATOR

Necmettin Erbakan University

Locations

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Necmettin Erbakan University

Konya, , Turkey (Türkiye)

Site Status

Turkey, Necmettin Erbakan University

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Nec EU

Identifier Type: -

Identifier Source: org_study_id

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