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

NCT ID: NCT04512664

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-05
• Study Completion Date: 2017-03-29

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.

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.

Conditions

Rhinoplasty; Cryotherapy Effect; Nurse's Role

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

short term group

cold treatment for 4 hours

Group Type: ACTIVE_COMPARATOR

cold application

Intervention Type: OTHER

cold application with gel pacs

long term group

cold treatment for 48 hours

Group Type: EXPERIMENTAL

cold application

Intervention Type: OTHER

cold application with gel pacs

Interventions

cold application

cold application with gel pacs

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Beykent

OTHER

Sponsor Role: lead

Responsible Party

Yasemin Eda Tekin

Register nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

YASEMİN EDA TEKİN, PHD

Role: PRINCIPAL_INVESTIGATOR

FACULTY MEMBER

Other Identifiers

beykent

Identifier Type: -

Identifier Source: org_study_id