Cold Application on Pain During Chest Tube Removal

NCT ID: NCT03307239

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-15

Study Completion Date

2015-09-15

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.

Detailed Description

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Conditions

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Chest Tube Removal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

subjects in the experimental group received cold application of 600 g ice packs 15 min before CTR, whereas subjects in the sham group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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cold application (experimental group)

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

Group Type EXPERIMENTAL

cold application

Intervention Type 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.

tap water packs application (sham group)

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

Group Type SHAM_COMPARATOR

tap water packs application

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiayi Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 29145288 (View on PubMed)

Other Identifiers

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103044

Identifier Type: -

Identifier Source: org_study_id