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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03307239
Other study ID # 103044
Secondary ID
Status Completed
Phase N/A
First received October 2, 2017
Last updated October 10, 2017
Start date September 15, 2014
Est. completion date September 15, 2015

Study information

Verified date October 2017
Source Chiayi Christian Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 15, 2015
Est. primary completion date September 15, 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chiayi Christian Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary numerical rating scale (NRS) the intensity of pain at the chest tube replacement before cold application
Primary numerical rating scale (NRS) the intensity of pain at the chest tube removal immediately after chest tube removal
Primary numerical rating scale (NRS) the intensity of pain at the chest tube removal 10 minutes after chest tube removal
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05046834 - Effect of Cold Application on Patient's Pain and Vital Signs During Chest Tube Removal. N/A
Completed NCT05032469 - Foot Reflexology to Reduce Pain and Anxiety Before Chest Tube Removal N/A
Completed NCT00873587 - Clinical Trial Evaluating the Optimal Technique for Chest Tube Removal N/A
Not yet recruiting NCT06444854 - Patient Reported Outcomes Targeting Early Chest Tube Removal (PROTECTR) Study N/A