Effect of Shotblocker and Palm Stimulator

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: shotblocker; Other: palm stimulator

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Meram, Turkey
    • Necmettin Erbakan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Experimental: shotblocker	Other: shotblocker; shotblocker device
Experimental: palm stimulator	Other: palm stimulator; palm stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University
• Investigators: Study Director: Gülden Basit, PhD, Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2024
• Primary Completion (Actual): May 23, 2024
• Study Completion (Actual): May 23, 2024

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 24YL9001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No