search
Back to results

The Effect of Different Bed Head Heights on Patients After Rhinoplasty

Primary Purpose

Rhinoplasty

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
the group with a bed head height of 45 degrees
the group with a bed head height of 30 degrees
Sponsored by
Bartın Unıversity
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rhinoplasty focused on measuring Rhinoplasty, Edema, Ecchymosis, Respiratory Function Tests, Sleep Quality

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Zonguldak Ataturk State HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

the group with a bed head height of 45 degrees

the group with a bed head height of 30 degrees

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 22, 2022
Last Updated
January 23, 2023
Sponsor
Bartın Unıversity
search

1. Study Identification

Unique Protocol Identification Number
NCT05695794
Brief Title
The Effect of Different Bed Head Heights on Patients After Rhinoplasty
Official Title
Evaluation of the Effect of Different Bed Head Heights After Rhinoplasty on Edema, Ecchymosis, Respiratory Function and Sleep Quality
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
March 21, 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bartın Unıversity

4. Oversight

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

5. Study Description

Brief Summary
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.
Detailed Description
The nose is morphologically a functional and aesthetic organ. These two concepts are inseparable and interact with each other. The nose is one of the structures most exposed to trauma, especially on the face. Rhinoplasty is one of the most common operations performed by plastic surgeons for functional correction or cosmetic purposes. When we examine the history of nose surgeries, we see that nose surgeries begin with reconstruction. Reduction rhinoplasty emerged later and forms the basis of today's rhinoplasty. The treatment of nasal trauma was first mentioned in the Edwin Smith Surgical Papyrus in 3000 BC (BC). In these papyri, 48 patients were reported to have been treated surgically. In the 5th century BC, Hippocrates made detailed patient analysis in his work named "Mochlicon" and classified nasal injuries from simple fracture to complicated. He discussed the reduction of nasal bones and their treatment with poultice. Most historians reported that nasal reconstruction was first mentioned in Sanskrit writings in Ancient India. In these writings, it was reported that the noses of Hindu women were cut as punishment. B.C. In the 6th century; Sushruta performed the reconstruction of the nose using his own instruments. He performed tissue transfer from forehead and cheek to nose. He called it the Indian Method. Sushruta mentioned the nasal reconstruction methods he developed in his book Samhita. 1st century There are articles describing the nose reconstruction in the book called De Medicina, which was written in Rome. VII. In the sculpture of the Byzantine Emperor in the 16th century, it is depicted that there is a scar on his forehead. It was accepted that this was a sign of nasal reconstruction. With the Muslim conquest of India, the nose reconstruction techniques applied in India started to be used in Muslim countries as well. XIV. Since the 19th century, the development of nose surgery has accelerated in Europe. XIV. Since the 19th century, the development of nose surgery has accelerated in Europe. XV. In the 19th century, the Italian surgeon Branca introduced the Indian Method in nose surgery to Europe. Branca's son Antonio, on the other hand, developed a new method in nose surgery and named it the "Italian Method". Nose surgeries have been performed with open technique for centuries. It was Jacques Joseph who coined the term "open rhinoplasty" for the first time, which he would later adopt in Millard and Gillies. Joseph is the scientist who introduced techniques such as nasal dorsum reconstruction with bone grafting and cartilage suturing to rhinoplasty. The first to describe the closed approach in rhinoplasty was John O Roe (1887), an American surgeon. Later, Weir presented the closed technique in 1892 and the German J. Joseph in 1898. In the closed technique, incisions are made through the nose, and in the open technique, a very small incision of approximately 2 millimeters in length is made in the columella of the nose (the part visible from the outside of the middle support) in addition to the incisions made through the nose. If the nose wings need to be narrowed; Additional incisions of approximately 5-6 millimeters can also be made so that they remain in the fold at the base of the nose wings. As with all surgical interventions, the comfort of the patient is important after rhinoplasty. Factors affecting the comfort of the patient in the early period after rhinoplasty; nausea, vomiting, bleeding, periorbital edema, periorbital ecchymosis, nasal airway obstruction and pain. Among these, the factors that most affect the comfort of the patient are; pain, periorbital edema and periorbital ecchymosis. Occurrence of periorbital edema and periorbital ecchymosis; Even if it is a natural result of the procedure, it is an undesirable result for patients who undergo this procedure with aesthetic demands. Postoperative periorbital edema and periorbital ecchymosis cause a delay in patients' return to daily life and adversely affect their social lives. Depending on the degree of periorbital edema, visual difficulties may also be experienced in the early postoperative period. Periorbital ecchymosis occurs by extravasation from damaged vessels and can be positioned by the effect of gravity. This may cause color change in the operation area and delays in returning to the patient's normal social life. Various agents such as corticosteroids, arnica, lidocaine, adrenaline combination and Melilotus extract and cold application methods for different durations have been used to reduce periorbital edema and periorbital ecchymosis after rhinoplasty. In line with these scanned literatures, it was observed that studies on bed head height after rhinoplasty were limited, and it was observed that there was no common decision on bed head heights given to patients in practice.For these reasons, it was decided to examine the effect of different bed head heights (thirty degrees and forty-five degrees) given to patients on periorbital edema, periorbital ecchymosis and respiratory functions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinoplasty
Keywords
Rhinoplasty, Edema, Ecchymosis, Respiratory Function Tests, Sleep Quality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
experimental group and control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the group with a bed head height of 45 degrees
Arm Type
Other
Arm Description
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.
Arm Title
the group with a bed head height of 30 degrees
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
the group with a bed head height of 45 degrees
Other Intervention Name(s)
Nursing care intervention for positioning appropriately after surgery
Intervention Description
Edema, ecchymosis, respiratory function and sleep quality will be evaluated by giving a 45 degree head height to 30 patients determined by Randomizer.org.
Intervention Type
Other
Intervention Name(s)
the group with a bed head height of 30 degrees
Other Intervention Name(s)
Nursing care intervention for positioning appropriately after surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Periorbital edema score
Description
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.
Time Frame
1 hour after surgery
Title
Periorbital edema score
Description
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.
Time Frame
4 hours after surgery
Title
Periorbital edema score
Description
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.
Time Frame
24th hour after surgery
Title
Right and left periorbital ecchymosis score
Description
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.
Time Frame
1 hour after surgery
Title
Right and left periorbital ecchymosis score
Description
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.
Time Frame
4 hours after surgery
Title
Right and left periorbital ecchymosis score
Description
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.
Time Frame
24th hour after surgery
Secondary Outcome Measure Information:
Title
Monitoring the change in fever
Description
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.
Time Frame
1 hour after surgery 4 hours after surgery 24th hour after surgery
Title
Monitoring the change in systolic blood pressure
Description
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.
Time Frame
1 hour after surgery 4 hours after surgery 24th hour after surgery
Title
Monitoring the change in diastolic blood pressure
Description
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.
Time Frame
1 hour after surgery 4 hours after surgery 24th hour after surgery
Title
Monitoring the change in pulse
Description
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.
Time Frame
1 hour after surgery 4 hours after surgery 24th hour after surgery
Title
Monitoring the change in oxygen saturation
Description
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.
Time Frame
1 hour after surgery 4 hours after surgery 24th hour after surgery
Title
Richard's Campbell Sleep Scale
Description
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.
Time Frame
1 hour after surgery 4 hours after surgery 24th hour after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Polat
Phone
05388480455
Email
sevvalseyrek74@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Şevval Polat
Phone
05388480455
Email
sevvalseyrek74@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şevval Polat
Organizational Affiliation
Uzunmehmet chest and occupational diseases hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zonguldak Ataturk State Hospital
City
Zonguldak
ZIP/Postal Code
67030
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Different Bed Head Heights on Patients After Rhinoplasty

We'll reach out to this number within 24 hrs