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Venous Cannulation PainNCT05920915

The Effect of the Cold Application on Venous Cannulation Pain

A study testing non-interventional clinical research in people with Venous Cannulation Pain and Nervous Vagus, run by Samsun University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Venous Cannulation Pain, Nervous Vagus, Cold
What is being tested?
non-interventional clinical research
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
159 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Jun 2023to 30 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75 years old
  • American Society of Anesthesiologists (ASA) I,II,III patients
  • Patients who will have elective surgery

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Şenay Canikli Adıgüzel

    Samsun, 55270

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Cold Application to the Lateral Neck Region on Venous Cannulation Pain: A Prospective Randomized Controlled Study

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.

Read the detailed description

Various ways have been tried to reduce cannulation pain. Methods such as local anesthetic injection to the intervention area, topical anesthetic use, ice application, and vibrating buzzi application were used to relieve the patient's pain and distract him. There are many different methods of stimulating the vagus nerve. The Valsalva maneuver is a mechanism that stimulates the Nervus Vagus (N. Vagus). Stimulation of the vagus nerve is thought to have an analgesic effect (2). Stimulation of the vagal nerve has an antinociceptive effect by triggering the baroreceptor reflex arc. It is thought that a P-like substance is released from the antinociceptive substance with the activation of the baroreceptor reflex arc. The regions where the N. Vagus is most superficial in the periphery are the inner auricle and the lateral neck region. It is also known that cold application to the lateral neck region stimulates the N. Vagus and reduces the heart rate (3). Applying cold to the neck area will have an antinociceptive effect by activating the baroreceptor reflex arc by stimulating the N. vagus. Patients between the ages of 18-70 who will be operated on electively (excluding those who will undergo oncological surgery and those who will undergo cesarean section) will be included in the study. These patients will be evaluated in the anesthesia polyclinic before the operation. Those with scars on the dorsum of the hand, operated on the dorsum of the hand, psoriasis, peripheral vascular disease, chronic analgesic use, opioid use, steroid use, gabapentin use, a history of substance abuse, peripheral neuropathy, oncological treatment, and limited cooperation patients will not be included in the study. The patients will be divided into 3 groups Group K, Group M, and Group S, with 53 people in each group. (The number of patients in the groups was calculated as α=0.05 and β=0.80 when power analysis was performed. The lottery method will be used for randomization.

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

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.

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

After the patients are taken to the operating room and monitored, we will use the method suitable for the groups we determined by drawing lots. Heart rate (HR), respiratory rate (RR), and noninvasive blood pressure (NIBB) will be recorded before the intravenous line is opened.HR, RR, and NIBB values will be recorded after the application to the neck area. Then, an 18 gauge (green) intravenous cannula will be inserted at once by the same experienced practitioner on the back of the left hand, and patients will be asked to rate their pain levels between 0-10 according to Numerical Rating Scale (NRS), and this value will be recorded. HR, RR, and NIBB values will also be recorded. Patients who cannot be cannulated at once will be excluded from the study.

The data of the patients will be recorded using the Statistical Package for the Social Sciences (SPSS) 18 program. The relationship between the NRS scores of all three groups and the patients' HR, RR, and NIBB values before cold application, after cold application, and during vascular access will be evaluated. Descriptive statistics, analysis of variance, and chi-square test will be used in the evaluation of the data. Mean±standard deviation and percentiles will be used in descriptive statistics. Results will be evaluated at a 95% confidence interval and significance as p<0.05.

Being tested
non-interventional clinical research
Medical subject headings
Common Cold

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • non-interventional clinical researchOther

    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

Study groups in NCT05920915
Study groupRoleWhat they receive
Group KPlacebo comparatorGroup K: Control group; 30 seconds (sec) will be waited before the vascular access is opened, no additional action will be taken.
Receives: Other: non-interventional clinical research
Group MExperimentalGroup 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.
Receives: Other: non-interventional clinical research
Group SSham comparatorGroup 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.
Receives: Other: non-interventional clinical research

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 minutes before induction of anesthesia

  2. Heart rate will be evaluated

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

    Measured: 5 minutes before induction of anesthesia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2023
  2. Study start18 Jun 2023
  3. Primary completion25 Jul 2023
  4. Study completion30 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05920915
Sponsor's protocol ID
SÜEK-2023 11/19
Status last verified
Nov 2023
First submitted
8 Jun 2023
Last updated
21 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26885298
  • 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.

    PubMed 16192551
  • 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.

    PubMed 30684416

Questions about this trial

What is this clinical trial studying?

A study testing non-interventional clinical research in people with Venous Cannulation Pain and Nervous Vagus, run by Samsun University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Venous cannulation pain (time frame: 5 minutes before induction of anesthesia). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05920915, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.

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