Effect of Cold Application Materials on Pain During Chest Tube Removal

Not Applicable

Completed

• Conditions: Local Application / Packing Too Cold
• Interventions: Other: Cold application

• Registration Number: NCT04200859
• Lead Sponsor: Mersin University

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.

Detailed Description

This study was aimed to determine which cold application material is more effective in pain control of patients during chest tube removal process.

The primary outcomes measures of this study were the effect of cold application materials on severity of pain.The secondary outcome measures of this study were duration of cold application and analgesic requirements of the patients.

Procedure Before removal of chest tube, nurse researcher (DS) who is working in the thoracic surgery clinic as a nurse, explained aim of study and take informed consent all patients. Data were collected with Patient Information Form and NRS.

Patient Information Form was filled out for each using the information obtained from patients/patients' relatives, patient files and health professionals of the clinic and the patients' pain severity was measured with NRS.

The patients were randomly assigned by a computer program to either intervention groups (ice pack or gel pad) or control group. Before the chest tube was removed, nurse researcher (DS) made cold application with ice pack the first experimental group and cold application with gel pad the second experimental group. The control group did not receive any intervention. Since the cold application temperature should be reduced to 13.6 °C in order to have local analgesic effect in both of the experimental groups the patient's skin temperature was measured at one-minute intervals by using an infrared non-contact thermometer (Microlife Non-Contact, Switzerland) with a wide measurement range (0-100 °C) and a measurement time of three seconds. This application was terminated when the temperature was 13.6 °C and the chest tube was removed by the physician.

Pain severity of all the patients was measured with NRS immediately after and 15 minutes after chest tube removal.

Study Timeline

• Study Start: 2016-09
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2019-12
• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-13
• Last Update Submitted: 2019-12-13
• Study First Posted: 2019-12-16
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

• Psychiatric disease
• Language problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold application with gel pad group	Cold application	Before the chest tube was removed, a gel pad with a radius of 15 cm was completely inserted around the chest tube
Cold application with ice pack	Cold application	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

Primary Outcome Measures

Name	Time	Method
effect of cold application materials on severity of pain	Change from first NRS at 15 minutes	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"

Secondary Outcome Measures

Name	Time	Method
effect of cold application materials on duration of cold application	30 minutes	The Patients Information Form was used to determine patients duration of cold application. How many minutes of cold application material applied
effect of cold application materials on analgesic requirements of the patients	up to 6 hours	The Patients Information Form was used to determine presence of analgesic administration after chest tube removal, time passed between the last analgesic time and chest tube removal time and time passed between chest tube removal time and the first analgesic administration time.