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Completed

NCT Number: NCT06381804

Effect of Shotblocker and Palm Stimulator

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University

Meram, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

shotblocker

Other

shotblocker device

palm stimulator

Other

palm stimulator

Primary outcomes

  1. Visual analog scale (VAS) pain Scale score

    Time frame: up to 6 weeks

    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

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2024
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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