Comparison of the Effects of ShotBlocker, Virtual Reality Glasses and Cold Application in Subcutaneous Heparin Injection

January 30, 2024 updated by: Ebru Erek Kazan, Ankara Yildirim Beyazıt University

Comparison of the Effects of ShotBlocker, Virtual Reality Glasses and Cold Application on Pain and Patient Satisfaction in Subcutaneous Heparin Injection Application in Adult Patients

This study aims to compare the effects of ShotBlocker, virtual reality glasses and cold application on pain and patient satisfaction in patients who were applied subcutaneous low molecular weight heparin (LMWH) injection in adult patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research being carried out in Ankara City Hospital Clinic of Orthopedics. The research sample is expected to consist of 150 adult patients, who will be randomly divided into three groups. First group will be applied ShotBlocker (n=50); second group will be applied Virtual Reality Glasses (n=50) and third group will be applied subcutaneous LMWH via cold application (n=50). So as to assess the effect of the injection, it will be applied on patients' left side within abdomen site via standard method (control) while the same will be done on patients' right side according to method of intervention (intervention). Therefore, each patient will form both intervention and control groups. Prior to subcutaneous LMWH injection, "Descriptive Characteristics Form", which includes participants' socio-demographic attributes (gender, marital status, age, level of education, etc.), will be filled out by the researcher by means of face-to-face interview. Following the injection, in order to evaluate patients' pain, "Visual Analog Scale for Pain" will be filled while "Visual Analog Scale for Satisfaction" will be used in order to identify patients' satisfaction with the application. It is expected that compared to standard injection, ShotBlocker, virtual reality glasses and cold application will reveal more positive results on pain and patient satisfaction during subcutaneous LMWH injection in adult patients. Besides, the method that has the more effect will be determined by comparing different methods. It is thought the data collected by the research will contribute to literature.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • 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
    • Çubuk
      • Ankara, Çubuk, Turkey, 06010
        • Ankara Yildirim Beyazit University Faculty of Health Sciences, Department of Nursing

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Open to communication
  • 18 or over years of age
  • Received 1x0,4 ml enoksaparin sodium treatment
  • Experienced no complications during or after operation
  • Normal values of thrombocyte (150.000-300.000), aPTT (25-35 sec) and INR (0.8-1.2) (Thrombocyte, INR and aPTT tests will be assessed in accordance with reference values of the kits that the hospital uses.)
  • No infection, scar tissue or incision in abdomen site
  • Received no parenteral treatment other than this site
  • Not diagnosed with any sort of coagulation disorder
  • No visual impairment to be able to wear VR glasses
  • No allergy to cold
  • No mental or neurological disability
  • No audio-visual impairment disability to be able to watch the video
  • Turkish speaking and comprehending
  • Non-pregnant
  • No hematological or allergic disease
  • Willing to be hospitalized for 2 days
  • Volunteer to participate in the research will constitute the research sample.

Exclusion Criteria:

During data collection, those who;

  • Renounce from participating in the research
  • Remove virtual reality glasses during or after operation
  • Fail to hold the cold pack for necessary period of time
  • Show signs of cold allergy during operation
  • Change institutions or were discharged early during research
  • Change dose of drugs within drug system
  • Develop drawbacks in the abdomen site will be excluded from the research.

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ShotBlocker Group
In control application, subcutaneous (SC) LMWH injection will be applied in patient's left abdomen with standard method on Post-op 0th day by the researcher. Intervention with ShotBlocker will be performed on the right abdomen site on post-op 1st day by the researcher. During subcutaneous LMWH injection with ShotBlocker, suitable injection site in right abdomen will be grasped by applying medium-weight pressure as ShotBlocker's obtuse touching points would touch the skin. In order to avoid ecchymosis and hematoma, it will be applied slowly for 10 seconds by entering from the middle point of ShotBlocker with a 90° angle. When injection is over, ShotBlocker will be removed 10 seconds will be waited. Removing the needle, the entry point will be applied light pressure with dry cotton for 10 seconds without any massage. Patients' level of pain and satisfaction will be assessed by a nurse working in the clinic with visual analog scale (VAS) within 1 minute after injection.
Device: Group 1
In each group, patients will be applied both standard subcutaneous heparin injection and with ShotBlocker.
Other Names:
  • ShotBlocker
Experimental: Virtual Reality Glasses (VRG) Group

Standard LMWH application will be performed on the left side for control on Post-op 0th day by the researcher.

Intervention with VRG will be performed on the right abdomen site on post-op 1st day. The researcher will show the patient a video 5 minutes before the injection providing them with virtual reality glasses, which will continue till the end of the operation, after which the glasses will be removed. Patients' level of pain and satisfaction will be assessed by a nurse working in the clinic with visual analog scale (VAS) within 1 minute after injection.
Device: Group 2
In each group, patients will be applied both standard subcutaneous heparin injection and with virtual reality glasses.
Other Names:
  • Virtual Reality Glasses (VRG)
Experimental: Cold Application Group
Standard heparin application will be performed on left side for control on post-op 0th day by the researcher. Intervention with cold application will be performed on the right abdomen site on post-op 1st day. Prior to the intervention, cold silica gel pack which stayed in the freezer for at least 2 hours will be placed on patient's injection site by wrapping up with towel and will be applied on the site for 5 minutes. After 5 minutes, the cold gel pack will be removed from the site and subcutaneous LMWH injection will be applied by the researcher. Following the removal of the injector, cold application will continue for another 2 minutes. Patients' level of pain and satisfaction will be assessed by a nurse working in the clinic with visual analog scale (VAS) after injection.
Device: Group 3
In each group, patients will be applied both standard subcutaneous heparin injection and with cold application.
Other Names:
  • Cold Application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessed by the VAS (Visual Analog Scale)
Time Frame: 4 month
In this research, in order to assess patients' level of injection pain, Visual Analog Scale (VAS) will be used. It is a 10 cm scale, on each side of which there is "no pain" and "worst pain". In using VAS, the patient is informed that they are free to choose a spot between two endpoints and the destination from the start of "no pain" and the spot the patient chooses is measured and recorded as cm./ mm. In this assessment, mean pain scores ranging among 1-10 are given. Thus, while "0" refers to no pain, 1-4 VAS values refer to dull pain; 5-6 to moderate pain; 7-10 refer to worst pain. Results will be compared both within group and among all groups at the end of the research.
4 month
Satisfaction assessed by the VAS (Visual Analog Scale)
Time Frame: 4 month
VAS is also used to measure components other than pain. VAS-Patient Satisfaction is a 10 cm scale, on each side of which there is "Dissatisfied" and "Very Satisfied". After injection, the patient is expect to detect their level of satisfaction by synthesizing affecting factors related to the process and mark the level of satisfaction on a line with a cross (X). High scores obtained from the scale refer to high levels of patient satisfaction. Results will be compared both within group and among all groups at the end of the research.
4 month

Collaborators and Investigators

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

Sponsor

Ankara Yildirim Beyazıt University

Investigators

  • Principal Investigator: Hafize Güllü, MsN, Ankara Yildirim Beyazit University , Faculty of Health Sciences, Department of Nursing

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)

March 1, 2023

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

July 25, 2023

Study Registration Dates

First Submitted

April 16, 2023

First Submitted That Met QC Criteria

April 16, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-1790

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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