Effect of Shotblocker on Procedure-related Pain, Satisfaction and Comfort in Patients Receiving Spinal Anesthesia

NCT06163027 | Unknown

• 1 other identifier: tulay22
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Although spinal anesthesia, which is increasingly common today, is a fast and reliable method, many patients are afraid of this procedure due to their fear of needles. Different methods have been studied to reduce pain during spinal needle insertion. One of the methods used to reduce pain due to needle insertion is ShotBlocker. This non-invasive, very simple to use application involves minimal risk and can be easily integrated into the application. For this reason, the research will be conducted to determine the effect of shot blockers on procedure-related pain, satisfaction and comfort in patients who will undergo spinal anesthesia.

Conditions

Pain

Keywords

Spinal Anesthesia; Shotblocker; Pain; Satisfaction; Comfort

Outcome Measures

Primary Outcomes (1)

• Visual analog scale

  The visual analog scale will be used to assess the patient's pain intensity. It is a self-reported scale in the form of a 10- cm ruler indicating no pain at one end and unbearable pain at the other. Accordingly, the patient is told to evaluate his/ her pain between 0 and 10, with 0 indicating "no pain" and 10 indicating "unbearable pain

  up to 24 hours

Secondary Outcomes (1)

• Comfort Scale

  up to 24 hours

Other Outcomes (1)

• Visual Patient Satisfaction Scale

  up to 24 hours

Study Arms (3)

Shotblocker

EXPERIMENTAL

Shotblocker (experimental) group: Patients will undergo standard monitoring. The shotblocker will be sterilized before the procedure. Sterilization of the shotblocker will be controlled by the indicator on the packaging. Necessary sterilization conditions for spinal anesthesia application will be met and the procedure will be performed from the L3 -L4 or L4 -L5 spinal range. During the spinal anesthesia process, the protruding surface of the shot blocker will be placed in the area to be inserted, just before the spinal needle application. The shotblocker will be kept stationary throughout the procedure and pressure will continue to be applied. After entering for the spinal anesthesia procedure, the shot blocker will be removed. During the spinal anesthesia procedure, VAS, patient satisfaction and comfort scale will be applied to the patient in the first 1 minute and at the 24th hour after surgery.

Device: Shotblocker

Placebo

PLACEBO COMPARATOR

Placebo group: Patients will undergo standard monitoring (electrocardiogram, noninvasive blood pressure, peripheral oxygen saturation). The shotblocker will be sterilized before the procedure. Sterilization of the shotblocker will be controlled by the indicator on the packaging. Necessary sterilization conditions for spinal anesthesia application will be met and the procedure will be performed from the L3 -L4 or L4 -L5 spinal range. During the spinal anesthesia procedure, the reverse side of the shotblocker (without protrusions) will be placed on the skin surface and gently pressed with the fingertips. The shotblocker will be kept stationary throughout the procedure and pressure will continue to be applied. After entering for the spinal anesthesia procedure, the shot blocker will be removed. During the spinal anesthesia procedure, VAS, patient satisfaction and comfort scale will be applied to the patient in the first 1 minute and at the 24th hour after surgery.

Other: Shotblocker(Plasebo)

Control

NO INTERVENTION

Routine treatment and care will be applied to the control group and no intervention will be made. During the spinal anesthesia procedure, VAS, patient satisfaction and comfort scale will be applied to the patient in the first 1 minute and at the 24th hour after surgery. The data obtained will be recorded in the patient diagnosis form. All interventions will be performed by the same anesthesiologist. The data will be filled in by a healthcare professional who is blinded to the study.

Interventions

Shotblocker DEVICE

Shotblocher will be administered during spinal needle injection

Shotblocker

Shotblocker(Plasebo) OTHER

The back side of the shotblocher will be applied during spinal needle injection

Placebo

Eligibility Criteria

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

You may qualify if:

• Being 18 years or older
• Does not have a disease that may cause loss of sensation or loss of sensation
• Be open to communication
• Volunteering to participate in research

You may not qualify if:

• Experiencing a change in consciousness,
• Patients receiving centrally or peripherally acting analgesics or sedatives
• Patients with clinical conditions requiring urgent intervention

Sponsors & Collaborators

• Ataturk University: lead

MeSH Terms

Conditions

Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: December 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-11