Cold Application on Pain During Chest Tube Removal

NCT03307239 | Completed

• 1 other identifier: 103044
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chest Tube Removal

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

cold application (experimental group)

EXPERIMENTAL

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

Other: cold application

tap water packs application (sham group)

SHAM COMPARATOR

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

Other: tap water packs application

Interventions

cold application OTHER

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.

cold application (experimental group)

tap water packs application OTHER

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.

tap water packs application (sham group)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• cold urticaria

Sponsors & Collaborators

• Chiayi Christian Hospital: lead

Related Publications (1)

• 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.

  PMID: 29145288 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the researcher assigned participants to one of the two groups: cold application (experimental group) or tap water packs application (sham group) according the random allocation sequence.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: subjects in the experimental group received cold application of 600 g ice packs 15 min before CTR, whereas subjects in the sham group

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 11, 2017
• Study Start: September 15, 2014
• Primary Completion: September 15, 2015
• Study Completion: September 15, 2015
• Last Updated: October 11, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share