ShotBlocker, Cold Needling, and Both Methods in Combination Pain and Satisfaction

NCT07258953 | Completed

• 1 other identifier: ShotBlocker and Cold Needle
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Intramuscular (IM) injections are one of the most frequently used pharmacological treatment methods in nursing practice. Reducing the pain experienced by patients during this procedure and ensuring patient satisfaction are important indicators of treatment quality. Reducing injection-related pain should be a priority in nursing care for both patient safety and the effectiveness of the treatment process. This study is a trpile-blind, randomized, controlled trial. It was designed to evaluate the effects of ShotBlocker, cold needle, and a combination of both methods during intramuscular injection on patient pain levels and satisfaction. The research will be conducted in the injection unit affiliated with the Adult Emergency Department of Konya City Hospital, Ministry of Health of the Republic of Turkey. The study population will consist of patients who presented for cyanocobalamin injections, and the sample will consist of 132 individuals who voluntarily agreed to participate in the study and met the inclusion criteria. Before conducting the study, ethical approval will be obtained from the Necmettin Erbakan University Health Sciences Ethics Committee and from the Konya City Hospital of the Ministry of Health of the Republic of Turkey. Collected data will be analyzed using the SPSS statistical package program (version 22.0; SPSS Inc., USA). The Kolmogorov-Smirnov test will be used to assess whether the data exhibit a normal distribution; statistical significance will be accepted as p\<0.05.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Visual Pain Scale (VAS)

  After the injection, the pain level will be determined using VAS.The lowest VAS score is "0" and the highest is "10." A higher score indicates greater pain.

  up to 5 months

Secondary Outcomes (1)

• Injection satisfaction

  up to 5 months

Study Arms (4)

ShotBlocker+cold needle

EXPERIMENTAL

During intramuscular injection, ShotBlocker and the cold needle will be used simultaneously.

Other: ShotBlocker+cold needle

Cold needle

EXPERIMENTAL

ShotBlocker will be used during intramuscular injection.

Other: ShotBlokcer

ShotBlocker

EXPERIMENTAL

A cold needle will be used during intramuscular injection.

Other: Cold needle

Control

PLACEBO COMPARATOR

Intramuscular injections will be performed according to standard technique.

Other: Control

Interventions

ShotBlocker+cold needle OTHER

During intramuscular injection, ShotBlocker and the cold needle will be used simultaneously.

ShotBlocker+cold needle

Cold needle OTHER

A cold needle will be used during intramuscular injection.

ShotBlocker

Control OTHER

Intramuscular injection will be conducted according to standard technique.

Control

ShotBlokcer OTHER

ShotBlocker will be used during intramuscular injection.

Cold needle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be between 18 and 65 years of age.
• Must have no problems speaking and understanding Turkish.
• Must have been prescribed 1000 mcg (1 ml ampoule) of cyanocobalamin IM injection.
• Must use the deltoid region for the injection.
• Must not be in the menstrual cycle.
• Must not be pregnant.
• Must have no history of diabetes.
• Must have a Body Mass Index (BMI) between 18.5 and 30.
• Must have no scars, incisions, lipodystrophy, or infection at the injection site.
• Must have no history of allergy to the medication.
• not using centrally or peripherally acting analgesics or sedatives,
• not having limb impairments,
• having a VAS score of "0" before the injection,
• agreeing to participate in the study.

You may not qualify if:

• Chronic or acute pain,
• Receiving oral or parenteral analgesic treatment before the study,
• Receiving another injection in the deltoid region,
• Developing a drug-related allergy or other complication,
• Having a contact-related infectious disease,
• Participants wishing to withdraw from the study.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Yadigar Yadigar

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomly assigned to groups and each will be taken individually to the injection unit. All injections will be administered by a single nurse working in the unit where the injections will be administered. The researcher will participate solely as an observer, will not intervene, and will not know which patient is in which group. Data obtained from the study will be coded as A, B, C, and D and submitted for statistical analysis. By concealing the group information, the analysis will be conducted objectively.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Group 1: ShotBlocker Group 2: Cold Needle Group 3: ShotBlocker + Cold Needle Group 4: Control

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: December 2, 2025
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 4, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)