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

Sponsor
University of Beykent (Other)
Overall Status
Completed
CT.gov ID
NCT04512664
Collaborator
(none)
60
2
26.7

Study Details

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
  • Other: cold application
N/A

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
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, 2-group, Single-blind, Randomized clinical trialProspective, 2-group, Single-blind, Randomized clinical trial
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Principal Investigator
Actual Study Start Date :
Jan 5, 2015
Actual Primary Completion Date :
Mar 29, 2017
Actual Study Completion Date :
Mar 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 [Postoperative 1st hour]

    Bruising around the eye

  2. Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 4th hour [Postoperative 4th hour]

    Bruising around the eye

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

    eyelid swelling

  2. Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 4th hour [postoperative 4th hour]

    eyelid swelling

  3. Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 2nd day [postoperative 2nd day]

    eyelid swelling

Other Outcome Measures

  1. Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st hour [postoperative 1st hour]

    Surgical site pain

  2. Surgical Site Pain as assesed using 100 point-VAS: postoperative 4th hour [postoperative 4th hour]

    Surgical site pain

  3. Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day morning before take the analgesic [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 [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 [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 [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 [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 [postoperative 2nd day after 45 minutes before take the analgesic]

    Surgical site pain

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

No locations specified.

Sponsors and Collaborators

  • University of Beykent

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yasemin Eda Tekin, Register nurse, University of Beykent
ClinicalTrials.gov Identifier:
NCT04512664
Other Study ID Numbers:
  • beykent
First Posted:
Aug 13, 2020
Last Update Posted:
Aug 13, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 13, 2020