Subcutaneous InjectionNCT05833646
Comparison of the Effects of ShotBlocker, Virtual Reality Glasses and Cold Application in Subcutaneous Heparin Injection
A study testing Group 1, Group 2 and Group 3 in people with Subcutaneous Injection, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subcutaneous Injection
- What is being tested?
- Group 1, Group 2 and Group 3
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yildirim Beyazit University Faculty of Health Sciences, Department of Nursing
Ankara, Çubuk, 06010
About this study
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
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.
Read the 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.
- Conditions
- Subcutaneous Injection
- Being tested
- Group 1, Group 2, Group 3
- Keywords
- Subcutaneous injection, Pain, Satisfaction, Virtual reality, ShotBlocker, Cold application, Nursing
- Medical subject headings
- Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Device
Also called ShotBlocker
In each group, patients will be applied both standard subcutaneous heparin injection and with ShotBlocker.
Group 2Device
Also called Virtual Reality Glasses (VRG)
In each group, patients will be applied both standard subcutaneous heparin injection and with virtual reality glasses.
Group 3Device
Also called Cold Application
In each group, patients will be applied both standard subcutaneous heparin injection and with cold application.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Group 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 Mar 2023
- Primary completion15 Mar 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subcutaneous InjectionStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Self-controlled, quasi-experimental
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Erek Kazan, Ankara Yildirim Beyazıt University
- Investigators
- Hafize Güllü, MsN, Principal investigator, Ankara Yildirim Beyazit University , Faculty of Health Sciences, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833646
- Sponsor's protocol ID
- 2022-1790
- Status last verified
- Jan 2024
- First submitted
- 16 Apr 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05833646
- Acronym / sponsor ID
- 2022-1790
- Conditions
- Subcutaneous Injection
- Keywords
- Subcutaneous injection, Pain, Satisfaction, Virtual reality, ShotBlocker, Cold application, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Self-controlled, quasi-experimental
| Arm | Type | Receives |
|---|---|---|
| ShotBlocker Group | Experimental | Device: Group 1In 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. |
| Virtual Reality Glasses (VRG) Group | Experimental | Device: Group 2Standard 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. |
| Cold Application Group | Experimental | Device: Group 3Standard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1Also: ShotBlockerIn each group, patients will be applied both standard subcutaneous heparin injection and with ShotBlocker. | Device | ShotBlocker Group |
| Group 2Also: Virtual Reality Glasses (VRG)In each group, patients will be applied both standard subcutaneous heparin injection and with virtual reality glasses. | Device | Virtual Reality Glasses (VRG) Group |
| Group 3Also: Cold ApplicationIn each group, patients will be applied both standard subcutaneous heparin injection and with cold application. | Device | Cold Application Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hafize Güllü, MsN principal investigator
Ankara Yildirim Beyazit University , Faculty of Health Sciences, Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1, Group 2 and Group 3 in people with Subcutaneous Injection, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessed by the VAS (Visual Analog Scale) (time frame: 4 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.