Effect of Cold Application Materials on Pain During Chest Tube Removal

NCT04200859 | Completed

• 1 other identifier: Mersin University
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Despite being an important treatment intervention, chest tube causes severe pain during removal because it attaches to the endothelium in the chest cavity. Objectives: This study aimed to determine the effectiveness of cold application with ice pack and gel pad in the control of pain experienced during chest tube removal. Design: Prospective, parallel three armed, randomized controlled trial. Settings: The study was conducted in athoracic surgery unit of a university hospital. Methods: The sample of this study consisted of 180 patients in two experimental groups and one control group.The patients were randomly assigned by a computer program to either intervention groups (ice pack or gel pad) or control group.One experimental group received cold application using ice pack and the other received cold application using gel pad until the skin temperature of all the patients fell to 13.6°C. The control group did not receive any intervention. Pain severity was assessed with Numerical Rating Scale (NRS) before chest tube removal, at the end of the procedure and 15 minutes after the procedure. Data was analyzed using descriptive statistics, chi-square, student t-test in independent groups, one-way analysis of variance (ANOVA), and repeated measures ANOVA.

Conditions

Local Application / Packing Too Cold

Keywords

chest tube,; chest tube removal; pain; cold aplication; nursing

Outcome Measures

Primary Outcomes (1)

• effect of cold application materials on severity of pain

  Numerical Rating Scale: The scale was used to determine the severity of pain during chest tube removal process. On this scale, patients are asked to describe their pain with numbers, with "0" indicating "no pain" and "10" indicating "the worst, unbearable pain"

  Change from first NRS at 15 minutes

Secondary Outcomes (2)

• effect of cold application materials on duration of cold application

  30 minutes

• effect of cold application materials on analgesic requirements of the patients

  up to 6 hours

Study Arms (3)

Cold application with ice pack

EXPERIMENTAL

Before the chest tube was removed, two ice packs with a size of 15.5x9cm were inserted around the chest tube so as to make as much contact as possible

Other: Cold application

Cold application with gel pad group

EXPERIMENTAL

Before the chest tube was removed, a gel pad with a radius of 15 cm was completely inserted around the chest tube

Other: Cold application

Control group

NO INTERVENTION

Routine analgesic drugs are not administered to patients before removal of the chest tube in thoracic surgery clinic. However, analgesic is performed according to the severity of pain after the procedure.

Interventions

Cold application OTHER

cold application using ice pack/gel pad in the control of pain experienced during chest tube removal

Cold application with gel pad group; Cold application with ice pack

Eligibility Criteria

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

You may qualify if:

• had chest tube
• Must be conscious, orientated and cooperated
• Must be able to speak and understand Turkish

You may not qualify if:

• Psychiatric disease
• Language problems

Sponsors & Collaborators

• Mersin University: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding in the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Prospective, parallel three armed, randomized controlled trial

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 16, 2019
• Study Start: September 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 16, 2019

Record last verified: 2019-12