Arterial PunctureNCT06661187
Simple Psychological Interventions and Cryoanalgesia
A study testing Cryoanalgesia, Psychological instructions and Routine care in people with Arterial Puncture, run by Damanhour University at 2 sites in Egypt.
Trial summary
This study aims to explore the effect of using simple psychological interventions and cryoanalgesia for reducing arterial punctures pain and anxiety in critically ill patients Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Puncture
- What is being tested?
- Cryoanalgesia, Psychological instructions and Routine care
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Dec 2024to 1 Jan 2026
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients of both genders.
- Consciousness patient required arterial puncture
Who cannot join
- Unconsciousness patients Patients with complicated site from arterial puncture
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Effect of Using Simple Psychological Interventions and Cryoanalgesia for Reducing Arterial Puncture Pain and Anxiety in Critically Ill Patients
This study aims to explore the effect of using simple psychological interventions and cryoanalgesia for reducing arterial punctures pain and anxiety in critically ill patients
Read the detailed description
The present study will be carried out in two interventions Patients who received cryoanalgesia: patients subjects underwent arterial puncture. patients in the intervention group had a small plastic bag filled with 12 oz of crushed ice applied to the radial artery puncture site for 3 min (timed with a stopwatch) without external compression or massage.
Psychological interventions using verbal signals of the impending procedure, music distraction, visual distraction, and breathing interventions be used during arterial puncture in adults
- Conditions
- Arterial Puncture
- Being tested
- Cryoanalgesia, Psychological instructions, Routine care
- Keywords
- Cryoanalgesia, Arterial Puncture, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoanalgesiaProcedure or surgery
Patients who received cryoanalgesia: patients subjects underwent arterial puncture. patients in the intervention group had a small plastic bag filled with 12 oz of crushed ice applied to the radial artery puncture site for 3 min (timed with a stopwatch) without external compression or massage.
Psychological instructionsProcedure or surgery
Psychological interventions using verbal signals of the impending procedure, music distraction, visual distraction, and breathing interventions be used during arterial puncture in adults
Routine careProcedure or surgery
No intervention deliver routine care
| Study group | Role | What they receive |
|---|---|---|
| Cryoanalgesia | Experimental | Patients who received cryoanalgesia: patients subjects underwent arterial puncture. patients in the intervention group had a small plastic bag filled with 12 oz of crushed ice applied to the radial artery puncture site for 3 min (timed with a stopwatch) without external compression or massage. Receives: Procedure: Cryoanalgesia |
| Psychological instructions | Experimental | Psychological interventions using verbal signals of the impending procedure, music distraction, visual distraction, and breathing interventions be used during arterial puncture injections in adults Receives: Procedure: Psychological instructions |
| control group | Placebo comparator | Patients received routine care Receives: Procedure: Routine care |
| Mixed group | Active comparator | received both interventions Receives: Procedure: Cryoanalgesia; Procedure: Psychological instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of pain using numerical pain scale
The patient is asked to rate their pain on a 0-10 scale, where: 0 = No pain 1-3 = Mild pain (nagging, annoying, but doesn't interfere much with daily activities) 4-6 = Moderate pain (noticeable, bothersome, may interfere with concentration or some activities) 7-10 = Severe pain (very intense, disabling, interferes with most activities or rest)
Measured: Three observations after the end arterial puncture procedure
Level of anxiety using the Hamilton Anxiety Rating Scale
Hamilton Anxiety Rating Scale consisted of 14 items measuring psychic anxiety (mental agitation) and somatic anxiety (physical complaints) Each item scored from 0 (not present) to 4 (severe) Total score ranges from 0-56, with higher scores indicating more severe
Measured: Two observations before and after arterial puncture procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Dec 2024
- Primary completion1 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial PunctureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- group one will use cryoanalgesia group two will use simple psychological instruction control group Group will use both method (cryoanalgesia and simple psychological instruction)
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661187
- Sponsor's protocol ID
- Cryoanalgesia
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Simple Psychological Interventions and Cryoanalgesia for Reducing Arterial Puncture Pain and Anxiety in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06661187
- Acronym / sponsor ID
- Cryoanalgesia
- Conditions
- Arterial Puncture
- Keywords
- Cryoanalgesia, Arterial Puncture, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 28 Oct 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.
This study aims to explore the effect of using simple psychological interventions and cryoanalgesia for reducing arterial punctures pain and anxiety in critically ill patients
Detailed description
The present study will be carried out in two interventions Patients who received cryoanalgesia: patients subjects underwent arterial puncture. patients in the intervention group had a small plastic bag filled with 12 oz of crushed ice applied to the radial artery puncture site for 3 min (timed with a stopwatch) without external compression or massage.
Psychological interventions using verbal signals of the impending procedure, music distraction, visual distraction, and breathing interventions be used during arterial puncture in adults
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- group one will use cryoanalgesia group two will use simple psychological instruction control group Group will use both method (cryoanalgesia and simple psychological instruction)
| Arm | Type | Receives |
|---|---|---|
| Cryoanalgesia | Experimental | Procedure: CryoanalgesiaPatients who received cryoanalgesia: patients subjects underwent arterial puncture. patients in the intervention group had a small plastic bag filled with 12 oz of crushed ice applied to the radial artery puncture site for 3 min (timed with a stopwatch) without external compression or massage. |
| Psychological instructions | Experimental | Procedure: Psychological instructionsPsychological interventions using verbal signals of the impending procedure, music distraction, visual distraction, and breathing interventions be used during arterial puncture injections in adults |
| control group | Placebo comparator | Procedure: Routine carePatients received routine care |
| Mixed group | Active comparator | Procedure: Cryoanalgesia, Procedure: Psychological instructionsreceived both interventions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult patients of both genders.
- Consciousness patient required arterial puncture
Key exclusion criteria (1 listed)
- Unconsciousness patients Patients with complicated site from arterial puncture
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 |
|---|---|---|
| CryoanalgesiaPatients who received cryoanalgesia: patients subjects underwent arterial puncture. patients in the intervention group had a small plastic bag filled with 12 oz of crushed ice applied to the radial artery puncture site for 3 min (timed with a stopwatch) without external compression or massage. | Procedure or surgery | Cryoanalgesia, Mixed group |
| Psychological instructionsPsychological interventions using verbal signals of the impending procedure, music distraction, visual distraction, and breathing interventions be used during arterial puncture in adults | Procedure or surgery | Mixed group, Psychological instructions |
| Routine careNo intervention deliver routine care | Procedure or surgery | control group |
Primary outcome
Severity of pain using numerical pain scale
Time frame: Three observations after the end arterial puncture procedure
The patient is asked to rate their pain on a 0-10 scale, where: 0 = No pain 1-3 = Mild pain (nagging, annoying, but doesn't interfere much with daily activities) 4-6 = Moderate pain (noticeable, bothersome, may interfere with concentration or some activities) 7-10 = Severe pain (very intense, disabling, interferes with most activities or rest)
Level of anxiety using the Hamilton Anxiety Rating Scale
Time frame: Two observations before and after arterial puncture procedure
Hamilton Anxiety Rating Scale consisted of 14 items measuring psychic anxiety (mental agitation) and somatic anxiety (physical complaints) Each item scored from 0 (not present) to 4 (severe) Total score ranges from 0-56, with higher scores indicating more severe
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 2 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoanalgesia, Psychological instructions and Routine care in people with Arterial Puncture, run by Damanhour University at 2 sites in Egypt.
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 2 inclusion and 1 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Severity of pain using numerical pain scale (time frame: Three observations after the end arterial puncture procedure). 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?
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 2 Mar 2026; AzTrials last refreshed its copy on 2 Nov 2026.