The Effect of the Cold Application on Venous Cannulation Pain

NCT05920915 | Completed

• 1 other identifier: SÜEK-2023 11/19
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

Intravenous (iv) cannulation is one of the most common practices performed by anesthesiologists in and outside the operating room. Vascular access is required before any anesthetic procedure. Venous cannulation is a moderately painful procedure and is uncomfortable for patients, and the pain of intravenous cannulation can increase the patient's stress. Various methods are used to reduce cannulation pain. N. Vagus stimulation is among these methods (1). In this study, we aim to evaluate vascular access pain by stimulating the Nervus Vagus with the cold application method to the neck region of our patients who applied venous cannulation from the back of the hand before anesthesia.

Conditions

Venous Cannulation Pain; Nervous Vagus; Cold

Outcome Measures

Primary Outcomes (2)

• Venous cannulation pain

  To evaluate the effect of cold application to the neck area on venous cannulation pain. Pain will be scaled from 0 to 10 on a numerical pain scale. To evaluate the effect of cold application to the neck area on venous cannulation pain.

  5 minutes before induction of anesthesia

• Heart rate will be evaluated

  Changes in heart rate will be evaluated (measured in heart rate/minute) during venous cannulation.

  5 minutes before induction of anesthesia

Study Arms (3)

Group K

PLACEBO COMPARATOR

Group K: Control group; 30 seconds (sec) will be waited before the vascular access is opened, no additional action will be taken.

Other: non-interventional clinical research

Group M

EXPERIMENTAL

Group M: Cold application group; Just before the vascular access was opened, a marble plaque was placed on the carotid (2-3 cm above the clavicle, on the sternocleidomastoid muscle (SCM) 2-3 cm above the clavicle) in the bilateral neck region, 4x5 cm in size, for 30 seconds.

Other: non-interventional clinical research

Group S

SHAM COMPARATOR

Group S: Sham group; Before the vascular access is opened, a marble plaque of 4x5 cm with a polar sheath on it will be applied bilaterally to the neck region of the patients for 30 seconds.

Other: non-interventional clinical research

Interventions

non-interventional clinical research OTHER

This study is a non-invasive clinical trial designed to observe the effect of applying cold to the neck area to effect of venous cannulation pain

Group K; Group M; Group S

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• American Society of Anesthesiologists (ASA) I,II,III patients
• Patients who will have elective surgery

You may not qualify if:

• Patients undergoing emergency surgery
• Patients who will undergo oncological surgery
• Pregnant patients
• Patients with scars on the back of the hand
• Those who have been operated on the back of the hand
• Patients with psoriasis Those with peripheral vascular disease
• Patients using chronic analgesics
• Patients using opioids
• Those who use steroids Those who use gabapentin
• Those with a history of substance use Those with peripheral neuropathy
• Patients who have received oncological treatment
• Patients with limited cooperation

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Şenay Canikli Adıgüzel

Samsun, 55270, Turkey (Türkiye)

Location

Related Publications (3)

• Kumar S, Gautam SK, Gupta D, Agarwal A, Dhirraj S, Khuba S. The effect of Valsalva maneuver in attenuating skin puncture pain during spinal anesthesia: a randomized controlled trial. Korean J Anesthesiol. 2016 Feb;69(1):27-31. doi: 10.4097/kjae.2016.69.1.27. Epub 2016 Jan 28.

  PMID: 26885298 BACKGROUND

• Agarwal A, Sinha PK, Tandon M, Dhiraaj S, Singh U. Evaluating the efficacy of the valsalva maneuver on venous cannulation pain: a prospective, randomized study. Anesth Analg. 2005 Oct;101(4):1230-1232. doi: 10.1213/01.ane.0000167270.15047.49.

  PMID: 16192551 BACKGROUND

• Jungmann M, Vencatachellum S, Van Ryckeghem D, Vogele C. Effects of Cold Stimulation on Cardiac-Vagal Activation in Healthy Participants: Randomized Controlled Trial. JMIR Form Res. 2018 Oct 9;2(2):e10257. doi: 10.2196/10257.

  PMID: 30684416 BACKGROUND

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Mustafa SÜREN

  Samsun University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomization will be done by closed envelope method
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical specialist (Anesthesiology and Reanimation)

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 27, 2023
• Study Start: June 18, 2023
• Primary Completion: July 25, 2023
• Study Completion: July 30, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

TU (1)