RhinoplastyNCT04512664
Different Cold Application Times on Ecchmosis, Edema and Pain After Rhinoplasty
A study testing cold application in people with Rhinoplasty and Cryotherapy Effect, run by University of Beykent.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rhinoplasty, Cryotherapy Effect, Nurse's Role
- What is being tested?
- cold application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2015to 29 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 years or older
- who underwent rhinoplasty / septorhinoplasty
- voluntarily participated in the study
Who cannot join
- Patients with cold allergy,
- refused to participate,
- performed outside the research protocol,
- required early re-operation due to postoperative complications
About this study
Official title: Principal Investigator
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.
Read the 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
- Being tested
- cold application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold applicationOther
cold application with gel pacs
| Study group | Role | What they receive |
|---|---|---|
| short term group | Active comparator | cold treatment for 4 hours Receives: Other: cold application |
| long term group | Experimental | cold treatment for 48 hours Receives: Other: cold application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 1st hour
Bruising around the eye
Measured: Postoperative 1st hour
Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 4th hour
Bruising around the eye
Measured: Postoperative 4th hour
Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 2nd day
Bruising around the eye
Measured: Postoperative 2nd day
Secondary outcomes (3)
Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 1st hour
eyelid swelling
Measured: postoperative 1st hour
Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 4th hour
eyelid swelling
Measured: postoperative 4th hour
Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 2nd day
eyelid swelling
Measured: postoperative 2nd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start5 Jan 2015
- Primary completion29 Mar 2017
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, 2-group, Single-blind, Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Eda Tekin, University of Beykent
- Investigators
- YASEMİN EDA TEKİN, PHD, Principal investigator, FACULTY MEMBER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512664
- Sponsor's protocol ID
- beykent
- Status last verified
- Aug 2020
- First submitted
- 25 Nov 2019
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator
- ClinicalTrials.gov ID
- NCT04512664
- Acronym / sponsor ID
- beykent
- Conditions
- Rhinoplasty, Cryotherapy Effect, Nurse's Role
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 5 Jan 2015 (actual)
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, 2-group, Single-blind, Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| short term group | Active comparator | Other: cold applicationcold treatment for 4 hours |
| long term group | Experimental | Other: cold applicationcold treatment for 48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 years or older
- who underwent rhinoplasty / septorhinoplasty
- voluntarily participated in the study
Key exclusion criteria (4 listed)
- Patients with cold allergy,
- refused to participate,
- performed outside the research protocol,
- required early re-operation due to postoperative complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cold applicationcold application with gel pacs | Other | long term group, short term group |
Primary outcome
Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 1st hour
Time frame: Postoperative 1st hour
Bruising around the eye
Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 4th hour
Time frame: Postoperative 4th hour
Bruising around the eye
Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 2nd day
Time frame: Postoperative 2nd day
Bruising around the eye
3 secondary outcomes
Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 1st hour
Time frame: postoperative 1st hour
Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 4th hour
Time frame: postoperative 4th hour
Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 2nd day
Time frame: postoperative 2nd day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YASEMİN EDA TEKİN, PHD principal investigator
FACULTY MEMBER
Questions about this trial
What is this clinical trial studying?
A study testing cold application in people with Rhinoplasty and Cryotherapy Effect, run by University of Beykent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 1st hour (time frame: Postoperative 1st hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.