Clinical trial NCT05833646: Comparison of the Effects of ShotBlocker, Virtual Reality Glasses and Cold Application in Subcutaneous Heparin Injection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subcutaneous Injection
Keywords: Subcutaneous injection
Pain
Satisfaction
Virtual reality
ShotBlocker
Cold application
Nursing
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Self-controlled, quasi-experimental
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain assessed by the VAS (Visual Analog Scale)
timeFrame: 4 month
measure: Satisfaction assessed by the VAS (Visual Analog Scale)
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazit University Faculty of Health Sciences, Department of Nursing
state: Çubuk
Study officials:
affiliation: Ankara Yildirim Beyazit University , Faculty of Health Sciences, Department of Nursing
name: Hafize Güllü, MsN
role: PRINCIPAL_INVESTIGATOR
References: