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

• ClinicalTrials.gov Identifier: NCT04512664
• Recruitment Status: Completed
• First Posted: August 13, 2020
• Last Update Posted: August 13, 2020
• Sponsor: University of Beykent
• Information provided by (Responsible Party): Yasemin Eda Tekin, University of Beykent

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rhinoplasty; Cryotherapy Effect; Nurse's Role	Other: cold application	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, 2-group, Single-blind, Randomized clinical trial
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Principal Investigator
• Actual Study Start Date: January 5, 2015
• Actual Primary Completion Date: March 29, 2017
• Actual Study Completion Date: March 29, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 1st hour [ Time Frame: Postoperative 1st hour ]
   Bruising around the eye
2. Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 4th hour [ Time Frame: Postoperative 4th hour ]
   Bruising around the eye
3. Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 2nd day [ Time Frame: Postoperative 2nd day ]
   Bruising around the eye

Secondary Outcome Measures :

1. Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 1st hour [ Time Frame: postoperative 1st hour ]
   eyelid swelling
2. Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 4th hour [ Time Frame: postoperative 4th hour ]
   eyelid swelling
3. Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 2nd day [ Time Frame: postoperative 2nd day ]
   eyelid swelling

Other Outcome Measures:

1. Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st hour [ Time Frame: postoperative 1st hour ]
   Surgical site pain
2. Surgical Site Pain as assesed using 100 point-VAS: postoperative 4th hour [ Time Frame: postoperative 4th hour ]
   Surgical site pain
3. Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day morning before take the analgesic [ Time Frame: postoperative 1st day morning before take the analgesic ]
   Surgical site pain
4. Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day morning after take the analgesic [ Time Frame: postoperative 1st day morning, 45 minutes after take the analgesic ]
   Surgical site pain
5. Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day evening, before take the analgesic [ Time Frame: postoperative 1st day evening, before take the analgesic ]
   Surgical site pain
6. Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day evening after take the analgesic [ Time Frame: postoperative 1st day evening, 45 minutes after take the analgesic ]
   Surgical site pain
7. Surgical Site Pain as assesed using 100 point-VAS: postoperative 2nd day morning before take the analgesic [ Time Frame: postoperative 2nd day morning before take the analgesic ]
   Surgical site pain
8. Surgical Site Pain as assesed using 100 point-VAS: postoperative 2nd day after before take the analgesic [ Time Frame: postoperative 2nd day after 45 minutes before take the analgesic ]
   Surgical site pain

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Sponsors and Collaborators

University of Beykent

Investigators

• Principal Investigator: YASEMİN EDA TEKİN, PHD; FACULTY MEMBER

More Information

• Responsible Party: Yasemin Eda Tekin, Register nurse, University of Beykent
• ClinicalTrials.gov Identifier: NCT04512664
• Other Study ID Numbers: beykent
• First Posted: August 13, 2020
• Last Update Posted: August 13, 2020
• Last Verified: August 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No