Clinical trial NCT04200859: Effect of Cold Application Materials on Pain During Chest Tube Removal
Official title: The Effect of Different Cold Application Materials on Pain During Chest Tube Removal: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Local Application / Packing Too Cold
Keywords: chest tube,
chest tube removal
pain
cold aplication
nursing
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel three armed, randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: effect of cold application materials on severity of pain
timeFrame: Change from first NRS at 15 minutes
Secondary outcomes:
measure: effect of cold application materials on duration of cold application
timeFrame: 30 minutes
measure: effect of cold application materials on analgesic requirements of the patients
timeFrame: up to 6 hours
Other outcomes:
Locations:
Study officials:
References: