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CompletedNCT03645369Updated Aug 24, 2018

Effectiveness of Mechano-Analgesia and Cold Application on Ecchymosis, Pain and Satisfaction at Subcutaneous Heparin Injection

An interventional study of ShotBlocker and Ice pack in Injection Site Reaction and Injection Site Bruising, sponsored by Istanbul Saglik Bilimleri University. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-08-24.

Sponsored by Istanbul Saglik Bilimleri University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Mar 2015, registered Aug 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
165
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Fifty-five patients received three subcutaneous heparin injections (165 injections) by the same investigator using additional techniques such as mechano-analgesia and cold application, and without any additional techniques.

Read the detailed description

The abdomen was divided into four quarters. The first, second, and third SC heparin injections were applied from the right abdominal region using ShotBlocker®, left abdominal region with an ice pack, and lower abdominal region without any additional application, respectively. All the injection sites were circled using a skin marking pen (r = 5 cm).

All the injections were administered following a standard procedure. Pain and satisfaction were assessed immediately after the injection by using the VAS score. Ecchymosis was assessed with an ecchymosis measurement tool at 48 and 60 hours after the injection (Figure 3).

02

Conditions studied

  • Injection Site Reaction
  • Injection Site Bruising

Keywords

  • subcutaneous heparin
  • injection pain
  • ecchymosis
03

In context

Injection Site Reaction

22 studies on the registry are indexed under Injection Site Reaction; 3 are open to participants now.

This study's enrollment of 165 is above the median of 60 across 17 interventional studies indexed under Injection Site Reaction.

Browse Injection Site Reaction studies →

Lead sponsor

Istanbul Saglik Bilimleri University is the lead sponsor of 60 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must be older than 18 years
  • Open to communication
  • No complications during the operation
  • Normal (BMI; reference range, 18.5-29.9 kg/m2) (d) and
  • count (150.000-300.000)
  • Give consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Oral and parenteral anticoagulant treatment for at least 5 days
  • Infection, scar tissue or incision, and parenteral treatment in their abdominal area
  • Hematological and allergic disease
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
165 participants (actual)

Study arms

  • Experimental
    Mechano-Analgesia

    The first SC heparin injections were applied from the right abdominal region using ShotBlocker®.

    Device: ShotBlocker

  • Experimental
    Cold Application

    The second SC heparin injections were applied from the left abdominal region with an ice pack

    Device: Ice pack

  • No intervention
    Control

    The second SC heparin injections were applied from the lower abdominal region without any additional application

Interventions

  • DeviceShotBlocker

    ShotBlocker is a drug-free tool with no side effects and does not require preparation. It is a flexible, plastic, C-shaped device with a number of short (2 mm) blunt contact points on its back.

  • DeviceIce pack

    Ice pack containing gel

06

What researchers measure

Primary outcomes

  1. Pain Intensity Measure via VAS

    The VAS was used to measure pain intensity. The VAS was composed of a 10-cm long line, which had subjective descriptive expressions on both sides (0 cm: no pain and 10 cm: unbearable pain). The individual was asked to make a sign on the line indicating the degree of the pain. The numerical values were recorded by the researcher.

    Time frame: Immediately after injection

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Celik N, Khorshid L. The Use of ShotBlocker for Reducing the Pain and Anxiety Associated With Intramuscular Injection: A Randomized, Placebo Controlled Study. Holist Nurs Pract. 2015 Sep-Oct;29(5):261-71. doi: 10.1097/HNP.0000000000000105. PubMed 26263287 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2015 to primary completion in Mar 2015, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2018
First posted
Aug 24, 2018
StartActual
Mar 2, 2015
Primary completionActual
Mar 15, 2015
CompletionActual
Dec 25, 2015
Last update
Aug 24, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03645369
Lead sponsor
Istanbul Saglik Bilimleri University
Responsible party
Demet İnangil, PhD (Principal Investigator, Istanbul Saglik Bilimleri University) — Principal investigator
First posted
Aug 24, 2018
Start date
Mar 2, 2015
Primary completion
Mar 15, 2015
Completion
Dec 25, 2015
Last update
Aug 24, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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