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CompletedNCT03307239Updated Oct 11, 2017

Cold Application on Pain During Chest Tube Removal

An interventional study of cold application and tap water packs application in Chest Tube Removal, sponsored by Chiayi Christian Hospital. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-10-11.

Sponsored by Chiayi Christian Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chest Tube Removal
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • cold urticaria
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    cold application (experimental group)

    subjects in the experimental group (n = 30) received cold application of 600 g ice packs 15 minutes before CTR

    Other: cold application

  • Sham comparator
    tap water packs application (sham group)

    subjects in the sham group (n = 30) received tap water packs.

    Other: tap water packs application

Interventions

  • Othercold application

    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.

  • Othertap water packs application

    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.

05

What researchers measure

Primary outcomes

  1. numerical rating scale (NRS)

    the intensity of pain at the chest tube replacement

    Time frame: before cold application

  2. numerical rating scale (NRS)

    the intensity of pain at the chest tube removal

    Time frame: immediately after chest tube removal

  3. numerical rating scale (NRS)

    the intensity of pain at the chest tube removal

    Time frame: 10 minutes after chest tube removal

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Hsieh LY, Chen YR, Lu MC. Efficacy of cold application on pain during chest tube removal: a randomized controlled trial: A CONSORT-compliant article. Medicine (Baltimore). 2017 Nov;96(46):e8642. doi: 10.1097/MD.0000000000008642. PubMed 29145288 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03307239
Lead sponsor
Chiayi Christian Hospital
Responsible party
Sponsor
First posted
Oct 11, 2017
Start date
Sep 15, 2014
Primary completion
Sep 15, 2015
Completion
Sep 15, 2015
Last update
Oct 11, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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