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

NCT05833646 | Completed

• 1 other identifier: 2022-1790
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subcutaneous Injection

Keywords

Subcutaneous injection; Pain; Satisfaction; Virtual reality; ShotBlocker; Cold application; Nursing

Outcome Measures

Primary Outcomes (2)

• Pain assessed by the VAS (Visual Analog Scale)

  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)

  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

Study Arms (3)

ShotBlocker Group

EXPERIMENTAL

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

Virtual Reality Glasses (VRG) Group

EXPERIMENTAL

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

Cold Application Group

EXPERIMENTAL

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

Interventions

Group 1 DEVICE

In each group, patients will be applied both standard subcutaneous heparin injection and with ShotBlocker.

Also known as: ShotBlocker

ShotBlocker Group

Group 2 DEVICE

In each group, patients will be applied both standard subcutaneous heparin injection and with virtual reality glasses.

Also known as: Virtual Reality Glasses (VRG)

Virtual Reality Glasses (VRG) Group

Group 3 DEVICE

In each group, patients will be applied both standard subcutaneous heparin injection and with cold application.

Also known as: Cold Application

Cold Application Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Open to communication
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yildirim Beyazit University Faculty of Health Sciences, Department of Nursing

Ankara, Çubuk, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Hafize Güllü, MsN

  Ankara Yildirim Beyazit University , Faculty of Health Sciences, Department of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Model Details: Self-controlled, quasi-experimental

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: April 27, 2023
• Study Start: March 1, 2023
• Primary Completion: March 15, 2023
• Study Completion: July 25, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)