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

Subcutaneous Injection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05833646
• Other study ID #: 2022-1790
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: July 25, 2023

Study information

• Verified date: January 2024
• Source: Ankara Yildirim Beyazit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 25, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Subcutaneous Injection

Intervention

Device:
• Group 1
In each group, patients will be applied both standard subcutaneous heparin injection and with ShotBlocker.
• Group 2
In each group, patients will be applied both standard subcutaneous heparin injection and with virtual reality glasses.
• Group 3
In each group, patients will be applied both standard subcutaneous heparin injection and with cold application.

Locations

Country	Name	City	State
Turkey	Ankara Yildirim Beyazit University Faculty of Health Sciences, Department of Nursing	Ankara	Çubuk

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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