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Cold Application on Pain During Chest Tube Removal

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ClinicalTrials.gov Identifier: NCT03307239
Recruitment Status : Completed
First Posted : October 11, 2017
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Chiayi Christian Hospital

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.


Condition or disease Intervention/treatment Phase
Chest Tube Removal Other: cold application Other: tap water packs application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Efficacy of Cold Application on Pain During Chest Tube Removal: A Randomized Controlled Trial : A CONSORT Compliant Article
Actual Study Start Date : September 15, 2014
Actual Primary Completion Date : September 15, 2015
Actual Study Completion Date : September 15, 2015

Arm Intervention/treatment
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

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.


Sham Comparator: tap water packs application (sham group)
subjects in the sham group (n = 30) received tap water packs.
Other: tap 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.





Primary Outcome Measures :
  1. numerical rating scale (NRS) [ Time Frame: before cold application ]
    the intensity of pain at the chest tube replacement

  2. numerical rating scale (NRS) [ Time Frame: immediately after chest tube removal ]
    the intensity of pain at the chest tube removal

  3. numerical rating scale (NRS) [ Time Frame: 10 minutes after chest tube removal ]
    the intensity of pain at the chest tube removal



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chiayi Christian Hospital
ClinicalTrials.gov Identifier: NCT03307239     History of Changes
Other Study ID Numbers: 103044
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No