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CompletedNCT06661187Updated Mar 2, 2026

Simple Psychological Interventions and Cryoanalgesia

An interventional study of Cryoanalgesia and Psychological instructions in Arterial Puncture, sponsored by Damanhour University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-02.

Sponsored by Damanhour University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Arterial Puncture

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Keywords

  • Cryoanalgesia
  • Arterial Puncture
  • Anxiety
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 120 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Damanhour University is the lead sponsor of 76 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult patients of both genders.
  • Consciousness patient required arterial puncture

Exclusion criteria

Exclusion Criteria:

  • Unconsciousness patients Patients with complicated site from arterial puncture
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Cryoanalgesia

    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.

    Procedure: Cryoanalgesia

  • Experimental
    Psychological instructions

    Psychological interventions using verbal signals of the impending procedure, music distraction, visual distraction, and breathing interventions be used during arterial puncture injections in adults

    Procedure: Psychological instructions

  • Placebo comparator
    control group

    Patients received routine care

    Procedure: Routine care

  • Active comparator
    Mixed group

    received both interventions

    Procedure: Cryoanalgesia · Procedure: Psychological instructions

Interventions

  • ProcedureCryoanalgesia

    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.

  • ProcedurePsychological instructions

    Psychological interventions using verbal signals of the impending procedure, music distraction, visual distraction, and breathing interventions be used during arterial puncture in adults

  • ProcedureRoutine care

    No intervention deliver routine care

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Three observations after the end arterial puncture procedure

  2. 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

    Time frame: Two observations before and after arterial puncture procedure

07

Study locations

2 sites
  • Damanhour university
    Damanhūr, Egypt
  • Faculty Of Nursing
    Damanhūr, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06661187
Lead sponsor
Damanhour University
Responsible party
Sponsor
First posted
Oct 28, 2024
Start date
Dec 1, 2024
Primary completion
Dec 1, 2025
Completion
Jan 1, 2026
Last update
Mar 2, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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