Simple Psychological Interventions and Cryoanalgesia

February 27, 2026 updated by: Damanhour University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Damanhūr, Egypt
        • Faculty of Nursing
      • Damanhūr, Egypt
        • Damanhour University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Unconsciousness patients Patients with complicated site from arterial puncture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
Psychological interventions using verbal signals of the impending procedure, music distraction, visual distraction, and breathing interventions be used during arterial puncture in adults
Placebo Comparator: control group
Patients received routine care
Procedure: Routine care
No intervention deliver routine care
Active Comparator: Mixed group
received both interventions
Procedure: 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: Psychological instructions
Psychological interventions using verbal signals of the impending procedure, music distraction, visual distraction, and breathing interventions be used during arterial puncture in adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Three observations after the end arterial puncture procedure
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
Two observations before and after arterial puncture procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

October 19, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cryoanalgesia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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