Simple Psychological Interventions and Cryoanalgesia

NCT06661187 | Completed DMC

• 1 other identifier: Cryoanalgesia
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Arterial Puncture

Keywords

Cryoanalgesia; Arterial Puncture; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  Two observations before and after arterial puncture procedure

Study Arms (4)

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.

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

Procedure: Psychological instructions

control group

PLACEBO COMPARATOR

Patients received routine care

Procedure: Routine care

Mixed group

ACTIVE COMPARATOR

received both interventions

Procedure: Cryoanalgesia; Procedure: Psychological instructions

Interventions

Cryoanalgesia PROCEDURE

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.

Cryoanalgesia; Mixed group

Psychological instructions PROCEDURE

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

Mixed group; Psychological instructions

Routine care PROCEDURE

No intervention deliver routine care

control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Unconsciousness patients Patients with complicated site from arterial puncture

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (2)

Damanhour university

Damanhūr, Egypt

Location

Faculty Of Nursing

Damanhūr, Egypt

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: group one will use cryoanalgesia group two will use simple psychological instruction control group Group will use both method (cryoanalgesia and simple psychological instruction)

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 28, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2024-10

Locations

EG (2)