Venous Canulation PainNCT06253299
Effect of Cold Application to Different Side Neck Region on Venous Cannulation Pain
An observational study of Venous Canulation Pain and Nervous Vagus, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
Intravenous (iv) cannulation is one of the most common applications performed by anesthesiologists in and outside the operating room. It is necessary to provide vascular access before any anesthetic procedure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Venous Canulation Pain, Nervous Vagus, Left Side
- What is being tested?
- marble stone
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2024to 30 Mar 2024
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Patients between the ages of 18-75 who will undergo elective surgery
Who may be able to join
- 18-75 years old
- ASA I,II,III patients
- Patients who will undergo 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
- Who had surgery on the back of the hand
- Patients with psoriasis
Show all 18Show fewer
- Those with peripheral vascular disease
- Patients using chronic analgesics
- Patients using opioids
- Those who use steroids
- Those who use gabapentinoids
- Those with a history of substance use
- Those with peripheral neuropathy
- Patients who have received oncological treatment
- Patients with limited cooperation
- Patients using medications that affect heart rate (such as beta blockers, calcium channel blockers)
- Patients with rhythm disorders
- Patients using cardiac pacemaker
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şenay Canikli Adıgüzel
Ataşehir, Samsun, 55025
About this study
Official title: How Applying Cold to Different Side Neck Region Affects Venous Cannulation Pain: Prospective Randomized Controlled Study
Intravenous (iv) cannulation is one of the most common applications performed by anesthesiologists in and outside the operating room. It is necessary to provide vascular access before any anesthetic procedure. Venous cannulation is a moderately painful procedure and is uncomfortable for patients, and the pain of intravenous cannulation may increase the patient's stress. Various methods are used to reduce cannulation pain. Stimulation of the N. Vagus is also among these methods (1). The branches of N. Vagus are densely located under the skin in the auricle and on the lateral aspect of the neck. It is thought that the dominance of the right and left vagal nerve over different systems is different. For example; While the right vagal branches are thought to be more effective on heart rate, the left side vagal branches are thought to be more effective in the treatment of refractory epilepsy. Purpose: Our aim in this study is to evaluate the vascular access pain in our patients to whom investigator applied venous cannulation from the back of the hand before anesthesia, by stimulating the Vagus Nerve with cold application to the neck area on both sides separately.
Read the detailed description
Various methods are being tried to reduce cannulation pain. Methods such as injection of local anesthetic into the intervention area, use of topical anesthetic, application of ice, and vibrating buzz application have been used to relieve the patient's pain and distract him. There are many different methods of stimulating the vagus nerve. Valsalva maneuver is a mechanism that stimulates 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 antinociceptive substance P-like substance is released with the activation of the baroreceptor reflex arc. The areas where N. Vagus is most superficial in the periphery are inside the auricle and the lateral neck region. It is also known that cold application to the lateral neck area reduces the heart rate by stimulating the N. Vagus (5). The degree of effect of vagal stimulation from different sides on different systems may be different (2,3). Applying cold to the neck area will have an antinociceptive effect by activating the baroreceptor reflex arc by stimulating the N. Vagus, and the degree of this effect may be effective differently with stimulation from the right or left side.
Method:
Patients aged 18-75 who will undergo elective surgery (except those who will undergo oncological surgery and those who will undergo cesarean section) will be included in the study. These patients will be evaluated at the anesthesia clinic before the operation. Those who have a scar on the back of the hand, who have had surgery on the back of the hand, who have psoriasis, who have peripheral vascular disease, who use chronic analgesics, who use opioids, who use steroids, who use gabapentinoids, who have a history of substance use, who have peripheral neuropathy, who have received oncological treatment and who have limited cooperation. patients will not be included in the study. Power analysis was done with G*Power 3.1.9.7 program. Before the study, the program was run to calculate the sample size to be equally distributed among the groups, assuming α = 0.05, power (1-β) = 0.80, effect size = 0.5. According to this program, the total number of samples is 128 and there are 64 people in each group. Taking into account recording errors, 70 people in each group and the total sample size was determined as 140 people) will be randomized into 2 groups: Group R (right side) and Group L (left side). The lottery method will be used for randomization.
Group R: Just before the vascular access is opened, a 4x5 cm cold marble stone will be held on the carotid in the right lateral neck area (2-3 cm above the clavicle, on the sternocleidomastoid muscle (SKM)) for 30 seconds (sec), and then the vascular access will be opened.
Group L: Just before the vascular access is opened, a 4x5 cm sized marble stone will be applied to the carotid in the left lateral neck region (2-3 cm above the clavicle, on the sternocleidomastoid muscle (SKM)) for 30 seconds, and then the vascular access will be opened.
Before vascular access is established, heart rate (HR), respiratory rate (RR) and noninvasive blood pressure (NIBB) will be recorded. HR, RR and NIBB values will be recorded after application to the neck area. Then, an 18-gauge (green colored) intraket will be inserted one time by the same experienced practitioner on the back of the left hand, and the patients will be asked to rate their pain levels between 0-10 according to the 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.
Patients' data will be recorded using SPSS 18 program. The relationship between the NRS scores of both 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 to evaluate the data. Mean±standard deviation and percentages will be used in descriptive statistics. Results will be evaluated at 95% confidence interval and significance at p<0.05.
- Conditions
- Venous Canulation Pain, Nervous Vagus, Left Side, Right Side
- Being tested
- marble stone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
marble stoneOther
Marble stones with dimensions of 4x5 cm will be used for cold application. When placed in the freezer compartment of the refrigerator at -10°C (Celsius) for 4 minutes, they cool down to 11°C. Subsequently, in 1 minute, the temperature rises to 12°C when held in the palm. "After being placed on a table at room temperature, it reaches 18°C in 5 minutes."
| Study group | Role | What they receive |
|---|---|---|
| Group L | Just before the vascular access is opened, a 4x5 cm sized marble stone will be applied to the carotid in the left lateral neck region (2-3 cm above the clavicle, on the sternocleidomastoid muscle (SKM)) for 30 seconds, and then the vascular access will be opened Receives: Other: marble stone | |
| Group R | Just before the vascular access is opened, a 4x5 cm cold marble stone will be held on the carotid in the right lateral neck area (2-3 cm above the clavicle, on the sternocleidomastoid muscle (SKM)) for 30 seconds (sec), and then the vascular access will be opened. Receives: Other: marble stone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous cannulation pain
Venous cannulation pain will be evaluated with the numerical pain scale (NRS).
Measured: preoperative period
Secondary outcomes (1)
heart rate
Measured: preoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start20 Feb 2024
- Primary completion20 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Canulation PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senay Canikli, Samsun University
- Investigators
- Senay canikli adıgüzel, Principal investigator, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253299
- Sponsor's protocol ID
- GOKAEK 2024/3/9
- Status last verified
- Apr 2024
- First submitted
- 1 Feb 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Applying Cold to Different Side Neck Region Affects Venous Cannulation Pain: Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06253299
- Acronym / sponsor ID
- GOKAEK 2024/3/9
- Conditions
- Venous Canulation Pain, Nervous Vagus, Left Side, Right Side
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intravenous (iv) cannulation is one of the most common applications performed by anesthesiologists in and outside the operating room. It is necessary to provide vascular access before any anesthetic procedure. Venous cannulation is a moderately painful procedure and is uncomfortable for patients, and the pain of intravenous cannulation may increase the patient's stress. Various methods are used to reduce cannulation pain. Stimulation of the N. Vagus is also among these methods (1). The branches of N. Vagus are densely located under the skin in the auricle and on the lateral aspect of the neck. It is thought that the dominance of the right and left vagal nerve over different systems is different. For example; While the right vagal branches are thought to be more effective on heart rate, the left side vagal branches are thought to be more effective in the treatment of refractory epilepsy. Purpose: Our aim in this study is to evaluate the vascular access pain in our patients to whom investigator applied venous cannulation from the back of the hand before anesthesia, by stimulating the Vagus Nerve with cold application to the neck area on both sides separately.
Detailed description
Various methods are being tried to reduce cannulation pain. Methods such as injection of local anesthetic into the intervention area, use of topical anesthetic, application of ice, and vibrating buzz application have been used to relieve the patient's pain and distract him. There are many different methods of stimulating the vagus nerve. Valsalva maneuver is a mechanism that stimulates 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 antinociceptive substance P-like substance is released with the activation of the baroreceptor reflex arc. The areas where N. Vagus is most superficial in the periphery are inside the auricle and the lateral neck region. It is also known that cold application to the lateral neck area reduces the heart rate by stimulating the N. Vagus (5). The degree of effect of vagal stimulation from different sides on different systems may be different (2,3). Applying cold to the neck area will have an antinociceptive effect by activating the baroreceptor reflex arc by stimulating the N. Vagus, and the degree of this effect may be effective differently with stimulation from the right or left side.
Method:
Patients aged 18-75 who will undergo elective surgery (except those who will undergo oncological surgery and those who will undergo cesarean section) will be included in the study. These patients will be evaluated at the anesthesia clinic before the operation. Those who have a scar on the back of the hand, who have had surgery on the back of the hand, who have psoriasis, who have peripheral vascular disease, who use chronic analgesics, who use opioids, who use steroids, who use gabapentinoids, who have a history of substance use, who have peripheral neuropathy, who have received oncological treatment and who have limited cooperation. patients will not be included in the study. Power analysis was done with G*Power 3.1.9.7 program. Before the study, the program was run to calculate the sample size to be equally distributed among the groups, assuming α = 0.05, power (1-β) = 0.80, effect size = 0.5. According to this program, the total number of samples is 128 and there are 64 people in each group. Taking into account recording errors, 70 people in each group and the total sample size was determined as 140 people) will be randomized into 2 groups: Group R (right side) and Group L (left side). The lottery method will be used for randomization.
Group R: Just before the vascular access is opened, a 4x5 cm cold marble stone will be held on the carotid in the right lateral neck area (2-3 cm above the clavicle, on the sternocleidomastoid muscle (SKM)) for 30 seconds (sec), and then the vascular access will be opened.
Group L: Just before the vascular access is opened, a 4x5 cm sized marble stone will be applied to the carotid in the left lateral neck region (2-3 cm above the clavicle, on the sternocleidomastoid muscle (SKM)) for 30 seconds, and then the vascular access will be opened.
Before vascular access is established, heart rate (HR), respiratory rate (RR) and noninvasive blood pressure (NIBB) will be recorded. HR, RR and NIBB values will be recorded after application to the neck area. Then, an 18-gauge (green colored) intraket will be inserted one time by the same experienced practitioner on the back of the left hand, and the patients will be asked to rate their pain levels between 0-10 according to the 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.
Patients' data will be recorded using SPSS 18 program. The relationship between the NRS scores of both 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 to evaluate the data. Mean±standard deviation and percentages will be used in descriptive statistics. Results will be evaluated at 95% confidence interval and significance at p<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L | – | Other: marble stoneJust before the vascular access is opened, a 4x5 cm sized marble stone will be applied to the carotid in the left lateral neck region (2-3 cm above the clavicle, on the sternocleidomastoid muscle (SKM)) for 30 seconds, and then the vascular access will be opened |
| Group R | – | Other: marble stoneJust before the vascular access is opened, a 4x5 cm cold marble stone will be held on the carotid in the right lateral neck area (2-3 cm above the clavicle, on the sternocleidomastoid muscle (SKM)) for 30 seconds (sec), and then the vascular access will be opened. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18-75 who will undergo elective surgery
Key inclusion criteria (3 listed)
- 18-75 years old
- ASA I,II,III patients
- Patients who will undergo elective surgery
Key exclusion criteria (18 listed)
- -Patients undergoing emergency surgery
- Patients who will undergo oncological surgery
- Pregnant patients
- Patients with scars on the back of the hand
- Who had surgery on the back of the hand
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| marble stoneMarble stones with dimensions of 4x5 cm will be used for cold application. When placed in the freezer compartment of the refrigerator at -10°C (Celsius) for 4 minutes, they cool down to 11°C. Subsequently, in 1 minute, the temperature rises to 12°C when held in the palm. "After being placed on a table at room temperature, it reaches 18°C in 5 minutes." | Other | Group L, Group R |
Primary outcome
Venous cannulation pain
Time frame: preoperative period
Venous cannulation pain will be evaluated with the numerical pain scale (NRS).
1 secondary outcome
heart rate
Time frame: preoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Senay canikli adıgüzel principal investigator
Samsun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Canulation 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 18 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 15 Apr 2024. 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. 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: preoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2024; AzTrials last refreshed its copy on 2 Nov 2026.