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

Nurse's Role Clinical Trial

Official title:

Principal Investigator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512664
• Other study ID #: beykent
• Status: Completed
• Phase: N/A
• Start date: January 5, 2015
• Est. completion date: March 29, 2017

Study information

• Verified date: August 2020
• Source: University of Beykent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 29, 2017
• Est. primary completion date: March 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cryotherapy Effect
• Nurse's Role
• Rhinoplasty

Intervention

Other:
• cold application
cold application with gel pacs

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Beykent

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st hour	Surgical site pain	postoperative 1st hour
Other	Surgical Site Pain as assesed using 100 point-VAS: postoperative 4th hour	Surgical site pain	postoperative 4th hour
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 1st hour	Bruising around the eye	Postoperative 1st hour
Primary	Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 4th hour	Bruising around the eye	Postoperative 4th hour
Primary	Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 2nd day	Bruising around the eye	Postoperative 2nd day
Secondary	Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 1st hour	eyelid swelling	postoperative 1st hour
Secondary	Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 4th hour	eyelid swelling	postoperative 4th hour
Secondary	Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 2nd day	eyelid swelling	postoperative 2nd day