Cryoanalgesia for Arterial Puncture Pain

NCT05251688 | Completed

• 1 other identifier: Cryoanalgesia
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Arterial puncture is a painful procedure performed to assess patients' acid-base and respiratory status. Pain is a stressful situation for unconscious patients as they cannot communicate their feeling verbally. To control patients' pain and avoid the adverse effects of painkillers, nonpharmacological pain management strategies have been solicited. therefore, this study aimed to investigate the effect of cryoanalgesia on unconscious patients' pain during arterial puncture.

Conditions

Cryotherapy Effect

Outcome Measures

Primary Outcomes (1)

• reducing pain intensity for unconscious patients during arterial puncture

  Unconscious patients' pain was assessed during the arterial puncture before and after application of cryoanalgesia using the behavioral pain scale. This scale was adopted from Chanques et al. (2009). It was used to assess the participants' pain. The original behavioral pain scale was developed by Payen et al. (2001) to assess pain for intubated and mechanically ventilated patients. It consists of three items: facial expressions, movements of the upper limbs, and compliance with MV with a score range from 3 (no pain) to 12 (severe pain). Later on, Chanques et al. (2009) adapted the original BPS to facilitate pain assessment for non-intubated or non-ventilated patients who were unable to self-report their pain. They switched the "compliance with ventilation" domain of the initial BPS to a "vocalization" domain in this new form of BPS and combined it with the two other parts. The total score still ranges from 3 to 12.

  pain intensity was assessed for two days

Study Arms (1)

participants

OTHER

The participants were encountered two times (before and after the application of cryoanalgesia).

Other: Cryoanalgesia

Interventions

Cryoanalgesia OTHER

On the first day of the study, the PI met the participants and assessed their level of consciousness using the Modified Glasgow Coma Scale to ensure that they were unconscious and reviewed the medical records to collect their sociodemographic data. After that, the participants received routine care before the arterial puncture. The PI assessed their pain scores during the puncture. In the second meeting (on the same day or the following day), the PI prepared the ice packs by crushing small pieces of ice and wrapping them in smooth gauze to avoid skin damage and moisture in the puncture area. Before the arterial puncture, the ice pack was applied over the selected puncture site (radial, brachial, or femoral artery) for 5 minutes in addition to the routine care. After removing the ice pack, the nurse palpated the artery, wiped of the residue of ice vapor present on the skin, and took the arterial blood sample. During the puncture, the PI assessed the participants' pain scores.

participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females who were ≥18years old and were unconscious according to the Modified Glasgow Coma Scale (MGCS)

You may not qualify if:

• Sedated patients and those who were on controlled mode mechanical ventilation (MV). Patients who had traumatic brain injuries or Raynaud's syndrome were also excluded.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Nursing, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Study Officials

• Sara Hegazy

  Faculty of Nursing, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: A quasi-experimental research design

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 23, 2022
• Study Start: June 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: October 30, 2019
• Last Updated: February 23, 2022

Record last verified: 2022-02

Locations

EG (1)