Effect of Shotblocker and Palm Stimulator

NCT06381804 | Completed

• 1 other identifier: 24YL9001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

shotblocker

EXPERIMENTAL

shotblocker

Other: shotblocker

palm stimulator

EXPERIMENTAL

palm stimulator

Other: palm stimulator

control

NO INTERVENTION

control

Interventions

shotblocker OTHER

shotblocker device

shotblocker

palm stimulator OTHER

palm stimulator

palm stimulator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Meram, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gülden Basit, PhD

  Necmettin Erbakan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 24, 2024
• Study Start: April 19, 2024
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)