Rhinoplasty Clinical Trial
Official title:
Evaluation of the Effect of Different Bed Head Heights After Rhinoplasty on Edema, Ecchymosis, Respiratory Function and Sleep Quality
Verified date | January 2023 |
Source | Bartin University |
Contact | Polat |
Phone | 05388480455 |
sevvalseyrek74[@]gmail.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will be conducted to evaluate the effect of different bed head heights (thirty degrees and forty-five degrees) given to patients after rhinoplasty surgery on periorbital edema, periorbital ecchymosis, respiratory function and sleep quality.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 2023 |
Est. primary completion date | March 21, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Zonguldak Ataturk State Hospital | Zonguldak |
Lead Sponsor | Collaborator |
---|---|
Bartin University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Periorbital edema score | This measurement tool has a single question and has options that score between 0-4:
0 points: No periorbital edema point: Mild periorbital edema points: Periorbital edema enlarged towards the iris layer of the eye points: Periorbital edema covering the iris points: Severe periorbital edema covering the eyelid completely With this measurement tool, the periorbital edema status of all patients will be evaluated in terms of periorbital edema as stated above, and a score will be given by the researcher immediately after the patients come to the service from the operating room, at the 1st hour, 4th hour and 24th hour. |
1 hour after surgery | |
Primary | Periorbital edema score | This measurement tool has a single question and has options that score between 0-4:
0 points: No periorbital edema point: Mild periorbital edema points: Periorbital edema enlarged towards the iris layer of the eye points: Periorbital edema covering the iris points: Severe periorbital edema covering the eyelid completely With this measurement tool, the periorbital edema status of all patients will be evaluated in terms of periorbital edema as stated above, and a score will be given by the researcher immediately after the patients come to the service from the operating room, at the 1st hour, 4th hour and 24th hour. |
4 hours after surgery | |
Primary | Periorbital edema score | This measurement tool has a single question and has options that score between 0-4:
0 points: No periorbital edema point: Mild periorbital edema points: Periorbital edema enlarged towards the iris layer of the eye points: Periorbital edema covering the iris points: Severe periorbital edema covering the eyelid completely With this measurement tool, the periorbital edema status of all patients will be evaluated in terms of periorbital edema as stated above, and a score will be given by the researcher immediately after the patients come to the service from the operating room, at the 1st hour, 4th hour and 24th hour. |
24th hour after surgery | |
Primary | Right and left periorbital ecchymosis score | 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 | |
Primary | Right and left periorbital ecchymosis score | 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 | |
Primary | Right and left periorbital ecchymosis score | 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 | |
Secondary | Monitoring the change in fever | 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. | 1 hour after surgery 4 hours after surgery 24th hour after surgery | |
Secondary | Monitoring the change in systolic blood pressure | 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. | 1 hour after surgery 4 hours after surgery 24th hour after surgery | |
Secondary | Monitoring the change in diastolic blood pressure | 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. | 1 hour after surgery 4 hours after surgery 24th hour after surgery | |
Secondary | Monitoring the change in pulse | 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. | 1 hour after surgery 4 hours after surgery 24th hour after surgery | |
Secondary | Monitoring the change in oxygen saturation | 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. | 1 hour after surgery 4 hours after surgery 24th hour after surgery | |
Secondary | Richard's Campbell Sleep Scale | 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. | 1 hour after surgery 4 hours after surgery 24th hour after surgery |
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