Effect of Shotblocker and Palm Stimulator

Pain Clinical Trial

Official title:

Effect of Shotblocker and Palm Stimulator in Reducing Pain Associated With Intramuscular Injection: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381804
• Other study ID #: 24YL9001
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2024
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study discusses the advancements in nursing, particularly focusing on intramuscular injections, their complications, and innovative non-pharmacological methods such as the Shotblocker and palm stimulator to reduce pain. These methods, based on the gate control theory, aim to minimize discomfort during injections by applying tactile stimulation, which has proven effective in various studies.

Description:

It was planned to examine the effect of shot blocker and palm stimulator use on injection-related pain during intramuscular injection.This study is a randomized controlled, single-blind, parallel group experimental study to be conducted in the emergency department of a State Hospital in Konya, Turkey. The research will be conducted on individuals who will receive intramuscular (IM) injection. Participants will be randomized and divided into Shotblocker, Palm stimulator and control groups. Data collection will run from April 2024 to May 2024 and analyzes will be conducted blinded by an independent statistician. This study aims to evaluate the effects of these techniques on pain and anxiety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Volunteering to participate in the research,
• Those who will receive vitamin B injection ordered by physician due to B12 deficiency,
• Conscious and oriented,
• Able to understand and speak Turkish,
• Age range is between 18-65,
• Having no vision or hearing problems,
• Pain score of 2 or less when evaluated with a visual analog scale,
• Able to lie in the right lateral position where injection can be administered,
• Those who have not had an IM injection into the right ventrogluteal area in the last week,
• Body mass index is within the normal range (25.0-29.9 kg/m2) according to WHO,
• Those who have not used any analgesics or muscle relaxants in the last 24 hours,
• Does not have any problems such as hardness, mass, edema or infection in the area to be injected,
• According to his own statement, he has no psychiatric diagnosis,

Exclusion Criteria:

• Having pain anywhere in the body,
• Narcotic type or different analgesic area before application,
• Pregnant or suspected of pregnancy,
• Individuals in menstrual period,
• Receiving chemotherapy and radiotherapy treatment,
• Those who have migraine, are in the postoperative period, have nerve damage, neuropathy and a vascular disease,
• Those who have disabilities in grasping their hands,

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• shotblocker
shotblocker device
• palm stimulator
palm stimulator

Locations

Country	Name	City	State
Turkey	Necmettin Erbakan University	Meram

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale (VAS) pain Scale score	The Visual analog scale (VAS) score for grading of pain consists of a 10 centimetres (cm) line with 10 mm (0.01 cm) to each point of the scale and two end-points representing no pain and worst possible pain, where 0 = no pain, 1-3 = mild, 4-6 = moderate and 7-10 = severe pain	up to 6 weeks