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

Principal Investigator

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.

Study Overview

• Status: Completed
• Conditions: Nurse's Role; Rhinoplasty; Cryotherapy Effect
• Intervention / Treatment: Other: cold application

Detailed Description

The research was carried out between January 2015 and March 2017 in an education and research hospital with a capacity of 26 beds. The research was suspended between July 2015 and January 2016. Patients who underwent rhinoplasty / septorhinoplasty operation between January 2015 and March 2017 with open or closed technique were included in the study. The study included patients who were 18 years of age or older who underwent a rhinoplasty / septorhinoplasty operation voluntarily. Patients who had cold allergy, refused to participate, applied outside of the research protocol and required re-operation in the early postoperative period due to complications were excluded from the study. All patients were provided with training and brochures for preoperative, intraoperative and postoperative periods. The cold application was done with gel pads of the same size and weight (13 cm x 13 cm-approximately 100 g) for 20 minutes per hour. Cold application was performed by the researcher in both groups for the first 4 hours. The patients in the short-term cold application group were given cold application by the researcher for 4 hours and 20 minutes per hour and the cold application was terminated. In the long-term application group, the first 4 hours of cold application were done by the researcher. Cold application after 4 hours; jel pads was applied at home by the patient's relative in accordance with the training given on the cold application protocol.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: short term group; cold treatment for 4 hours	Other: cold application; cold application with gel pacs
Experimental: long term group; cold treatment for 48 hours	Other: cold application; cold application with gel pacs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 1st hour	eyelid swelling	postoperative 1st hour
Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 4th hour	eyelid swelling	postoperative 4th hour
Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 2nd day	eyelid swelling	postoperative 2nd day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st hour	Surgical site pain	postoperative 1st hour
Surgical Site Pain as assesed using 100 point-VAS: postoperative 4th hour	Surgical site pain	postoperative 4th hour
Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day morning before take the analgesic	Surgical site pain	postoperative 1st day morning before take the analgesic
Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day morning after take the analgesic	Surgical site pain	postoperative 1st day morning, 45 minutes after take the analgesic
Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day evening, before take the analgesic	Surgical site pain	postoperative 1st day evening, before take the analgesic
Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day evening after take the analgesic	Surgical site pain	postoperative 1st day evening, 45 minutes after take the analgesic
Surgical Site Pain as assesed using 100 point-VAS: postoperative 2nd day morning before take the analgesic	Surgical site pain	postoperative 2nd day morning before take the analgesic
Surgical Site Pain as assesed using 100 point-VAS: postoperative 2nd day after before take the analgesic	Surgical site pain	postoperative 2nd day after 45 minutes before take the analgesic

Collaborators and Investigators

• Sponsor: University of Beykent
• Investigators: Principal Investigator: YASEMİN EDA TEKİN, PHD, Faculty Member

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2015
• Primary Completion (Actual): March 29, 2017
• Study Completion (Actual): March 29, 2017

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: beykent

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No