Nurse's Role Clinical Trial
Official title:
Principal Investigator
NCT number | NCT04512664 |
Other study ID # | beykent |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 5, 2015 |
Est. completion date | March 29, 2017 |
Verified date | August 2020 |
Source | University of Beykent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Beykent |
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 |
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