- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05695794
The Effect of Different Bed Head Heights on Patients After Rhinoplasty
Evaluation of the Effect of Different Bed Head Heights After Rhinoplasty on Edema, Ecchymosis, Respiratory Function and Sleep Quality
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Polat
- Phone Number: 05388480455
- Email: sevvalseyrek74@gmail.com
Study Contact Backup
- Name: Şevval Polat
- Phone Number: 05388480455
- Email: sevvalseyrek74@gmail.com
Study Locations
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-
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Zonguldak, Turkey, 67030
- Recruiting
- Zonguldak Ataturk State Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participating in the research voluntarily
- Patients over the age of 18
- Patients who have undergone rhinoplasty for aesthetic purposes
- Can speak Turkish
- Patients who do not have a mental disability that may interfere with communication
- Patients who had rhinoplasty with open technique
- Patients without diagnosed respiratory and sleep disorders
Exclusion Criteria:
- Patients who did not agree to participate in the study
- Patients under the age of 18
- Patients who underwent rhinoplasty surgery due to trauma
- Patients with mental disabilities who interfere with communication
- Patients who cannot adapt to bed height
- Patients who had rhinoplasty surgery with the closed technique
- Patients with diagnosed respiratory and sleep disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: the group with a bed head height of 45 degrees
The bed head height of the patients in this group will be adjusted to 45 degrees.
This group was determined as the control group since the patients were given a 45-degree head height as a standard in the hospital where the study would be conducted.
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Edema, ecchymosis, respiratory function and sleep quality will be evaluated by giving a 45 degree head height to 30 patients determined by Randomizer.org.
Other Names:
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Experimental: the group with a bed head height of 30 degrees
The bed head height of the patients in this group will be adjusted to 30 degrees.
This group was determined as the experimental group since the patients were given a 45-degree head height as a standard in the hospital where the study would be conducted.
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Edema, ecchymosis, respiratory function and sleep quality will be evaluated by giving 30 degrees of bed head height to 30 patients determined by Randomizer.org.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Periorbital edema score
Time Frame: 1 hour after surgery
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This measurement tool has a single question and has options that score between 0-4: 0 points: No periorbital edema
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1 hour after surgery
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Periorbital edema score
Time Frame: 4 hours after surgery
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This measurement tool has a single question and has options that score between 0-4: 0 points: No periorbital edema
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4 hours after surgery
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Periorbital edema score
Time Frame: 24th hour after surgery
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This measurement tool has a single question and has options that score between 0-4: 0 points: No periorbital edema
|
24th hour after surgery
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Right and left periorbital ecchymosis score
Time Frame: 1 hour after surgery
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Right and left periorbital ecchymosis; Right and left eyelids of all patients will be evaluated separately according to the following scale at the 1st, 4th and 24th hours, immediately after the patients come to the service from the operating room. Scoring diagram for ecchymosis; Grade 1, medial ecchymosis up to one-third of the lower and/or upper eyelid. Grade 2, ecchymosis up to the medial two-thirds of the lower and/or upper eyelid. 3rd degree ecchymosis to the entire length of the lower and/or upper eyelid. |
1 hour after surgery
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Right and left periorbital ecchymosis score
Time Frame: 4 hours after surgery
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Right and left periorbital ecchymosis; Right and left eyelids of all patients will be evaluated separately according to the following scale at the 1st, 4th and 24th hours, immediately after the patients come to the service from the operating room. Scoring diagram for ecchymosis; Grade 1, medial ecchymosis up to one-third of the lower and/or upper eyelid. Grade 2, ecchymosis up to the medial two-thirds of the lower and/or upper eyelid. 3rd degree ecchymosis to the entire length of the lower and/or upper eyelid. |
4 hours after surgery
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Right and left periorbital ecchymosis score
Time Frame: 24th hour after surgery
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Right and left periorbital ecchymosis; Right and left eyelids of all patients will be evaluated separately according to the following scale at the 1st, 4th and 24th hours, immediately after the patients come to the service from the operating room. Scoring diagram for ecchymosis; Grade 1, medial ecchymosis up to one-third of the lower and/or upper eyelid. Grade 2, ecchymosis up to the medial two-thirds of the lower and/or upper eyelid. 3rd degree ecchymosis to the entire length of the lower and/or upper eyelid. |
24th hour after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Monitoring the change in fever
Time Frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery
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Vital signs (fever) will be monitored every fifteen minutes in the first hour after the surgery, every thirty minutes in the next hour, and hourly thereafter.
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1 hour after surgery 4 hours after surgery 24th hour after surgery
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Monitoring the change in systolic blood pressure
Time Frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery
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Vital signs (systolic blood pressure) will be monitored every fifteen minutes in the first hour after the surgery, every thirty minutes in the next hour, and hourly thereafter.
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1 hour after surgery 4 hours after surgery 24th hour after surgery
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Monitoring the change in diastolic blood pressure
Time Frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery
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Vital signs (diastolic blood pressure) will be monitored every fifteen minutes in the first hour after the surgery, every thirty minutes in the next hour, and hourly thereafter.
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1 hour after surgery 4 hours after surgery 24th hour after surgery
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Monitoring the change in pulse
Time Frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery
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Vital signs (pulse) will be monitored every fifteen minutes in the first hour after the surgery, every thirty minutes in the next hour, and hourly thereafter.
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1 hour after surgery 4 hours after surgery 24th hour after surgery
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Monitoring the change in oxygen saturation
Time Frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery
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The change in the oxygen saturation values of the patients will be followed by noninvasive peripheral pulse oximetry.The patient's oxygen saturation value will be monitored every 4 hours, unlike the routine treatment and follow-up hours of the hospital.
The saturation value will not be measured while the patient is asleep.
A questionnaire will be applied to the patient to evaluate the patient's breathing in the morning after the surgery.
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1 hour after surgery 4 hours after surgery 24th hour after surgery
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Richard's Campbell Sleep Scale
Time Frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery
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It is a scale consisting of 6 items.
These 6 items evaluate the depth of night sleep, the time to fall asleep, the frequency of waking up, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment.
Evaluation of the scale, on the other hand, is that the score between 0-25 is "very bad sleep", and the score between "76-100" is "very good sleep".
As the score of the scale increases, the sleep quality of the patients also increases.
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1 hour after surgery 4 hours after surgery 24th hour after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Şevval Polat, Uzunmehmet chest and occupational diseases hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BartınU-SBF-SP-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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