Effect of Two Different Methods on Pain and Anxiety

Sponsor

Necmettin Erbakan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05769647

Collaborator

(none)

111

Enrollment

Location

Arms

Anticipated Duration (Days)

112.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Device: Virtual Reality Glasses Device: Stress Ball	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

111 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Pain evaluated using the Visual Pain Scale [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 Outcome Measures

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.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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,
Body mass index (BMI) being within normal limits (18.5-24.9),
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),
Using sedatives or alcohol,
Receiving chemotherapy with peripheral venous catheter

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Turkey, Necmettin Erbakan University	Konya		Turkey	42040

Sponsors and Collaborators

Necmettin Erbakan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Serpil SU, Assistant Professor, Necmettin Erbakan University

ClinicalTrials.gov Identifier:

NCT05769647

Other Study ID Numbers:

Nec EU

First Posted:

Mar 15, 2023

Last Update Posted:

Mar 15, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Serpil SU, Assistant Professor, Necmettin Erbakan University

Peripheral Intravenous Catheter Insertion

Pain

Anxiety

Study Results

No Results Posted as of Mar 15, 2023