Cold Application on Pain During Chest Tube Removal

Study Overview
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Brief Summary
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Abstract Objectives: Use of analgesics is the most common method to alleviate the pain induced by chest tube removal (CTR), but patient response to medication can vary and may not be achieved complete relaxation. This study was to determine the effectiveness of cold application in combination with standard analgesic administration before CTR on CTR-induced pain. Methods: A prospective, randomized, single-blind, placebo sham-controlled study was conducted. In addition to the same routine care, subjects in the experimental group (n = 30) received cold application of 600 g ice packs 15 minutes before CTR, whereas subjects in the placebo sham group (n = 30) received tap water packs. Numerical rating scale was used to measured pain intensity before, immediately after, and 10 minutes after CTR.

Official Title
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Efficacy of Cold Application on Pain During Chest Tube Removal: A Randomized Controlled Trial : A CONSORT Compliant Article

Conditions
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Chest Tube Removal

Intervention / Treatment
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* Other: cold application
* Other: tap water packs application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (a) age greater than 20 years, (b) single chest-tube insertion, (c) first-time insertion of the chest tube, (d) ability to verbally report pain, (e) body mass index of < 30 kg/m2, and (f) normal vital signs. Exclusion Criteria: cold urticaria

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: subjects in the experimental group received cold application of 600 g ice packs 15 min before CTR, whereas subjects in the sham group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cold application (experimental group)<br>subjects in the experimental group (n = 30) received cold application of 600 g ice packs 15 minutes before CTR | Other: cold application<br>* We manufactured two ice packs (17 × 12 cm) with a combined weight of 600 g. The ice packs were inserted into adjustable wraps made in our hospital so that they can be fixed next to the skin on each side of the chest tube in patients awaiting CTR. The combined contact area of the ice packs was approximately 25 cm in diameter around the chest tube. For patients of the experimental group, they were received 15-minutes cold application.<br>|
| Sham Comparator: tap water packs application (sham group)<br>subjects in the sham group (n = 30) received tap water packs. | Other: tap water packs application<br>* We manufactured two tap water packs (17 × 12 cm) with a combined weight of 600 g. The tap water packs were inserted into adjustable wraps made in our hospital so that they can be fixed next to the skin on each side of the chest tube in patients awaiting CTR. The combined contact area of the tap water packs was approximately 25 cm in diameter around the chest tube. For patients of the sham group, they were received 15-minutes tap water application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numerical rating scale (NRS) | the intensity of pain at the chest tube replacement | before cold application | 
| numerical rating scale (NRS) | the intensity of pain at the chest tube removal | immediately after chest tube removal | 
| numerical rating scale (NRS) | the intensity of pain at the chest tube removal | 10 minutes after chest tube removal |