Different Cold Application Times on Ecchmosis, Edema and Pain After Rhinoplasty

NCT04512664 | Completed DMC

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

Brief Summary

The aim of this study is to investigate the effects of different cold application times with cold gel pads after rhinoplasty on eyelid edema, eye ecchymosis and pain. A total of 60 patients undergoing rhinoplasty were divided into two groups by simple randomization method. Cold application applied to short term group for 4 hours and to long term group for 48 hours. Cold application was applied around both eyes with cold gel pads for 20 minutes per hour. Pain was evaluated with the Visuel Analog Scale, ecchymosis with eyelid ecchymosis score, and edema with eye-edema score. Edema and ecchymosis were evaluated on the 1st and 4th hours and 2nd day. Pain conditions were evaluated before and after analgesics for 1, 4 hours and 2 times daily.

Conditions

Rhinoplasty; Cryotherapy Effect; Nurse's Role

Outcome Measures

Primary Outcomes (3)

• Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 1st hour

  Bruising around the eye

  Postoperative 1st hour

• Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 4th hour

  Bruising around the eye

  Postoperative 4th hour

• Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 2nd day

  Bruising around the eye

  Postoperative 2nd day

Secondary Outcomes (3)

• Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 1st hour

  postoperative 1st hour

• Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 4th hour

  postoperative 4th hour

• Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 2nd day

  postoperative 2nd day

Other Outcomes (8)

• Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st hour

  postoperative 1st hour

• Surgical Site Pain as assesed using 100 point-VAS: postoperative 4th hour

  postoperative 4th hour

• Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day morning before take the analgesic

  postoperative 1st day morning before take the analgesic

Study Arms (2)

short term group

ACTIVE COMPARATOR

cold treatment for 4 hours

Other: cold application

long term group

EXPERIMENTAL

cold treatment for 48 hours

Other: cold application

Interventions

cold application OTHER

cold application with gel pacs

long term group; short term group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years or older
• who underwent rhinoplasty / septorhinoplasty
• voluntarily participated in the study

You may not qualify if:

• Patients with cold allergy,
• refused to participate,
• performed outside the research protocol,
• required early re-operation due to postoperative complications

Sponsors & Collaborators

• University of Beykent: lead

Study Officials

• YASEMİN EDA TEKİN, PHD

  FACULTY MEMBER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Register nurse

Model Details: Prospective, 2-group, Single-blind, Randomized clinical trial

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: August 13, 2020
• Study Start: January 5, 2015
• Primary Completion: March 29, 2017
• Study Completion: March 29, 2017
• Last Updated: August 13, 2020

Record last verified: 2020-08