ClinicalTrials.gg
Status unknownNCT05695794Updated Jan 25, 2023

The Effect of Different Bed Head Heights on Patients After Rhinoplasty

An interventional study of the group with a bed head height of 45 degrees and the group with a bed head height of 30 degrees in Rhinoplasty, sponsored by Bartın Unıversity. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-25.

Sponsored by Bartın Unıversity · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rhinoplasty

Keywords

  • Rhinoplasty
  • Edema
  • Ecchymosis
  • Respiratory Function Tests
  • Sleep Quality
03

In context

Edema

566 studies on the registry are indexed under Edema; 95 are open to participants now.

This study's planned enrollment of 60 is above the median of 52 across 401 interventional studies indexed under Edema.

Browse Edema studies →

Lead sponsor

Bartın Unıversity is the lead sponsor of 47 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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.

    Other: the group with a bed head height of 45 degrees

  • 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.

    Other: the group with a bed head height of 30 degrees

Interventions

  • Otherthe group with a bed head height of 45 degrees

    Edema, ecchymosis, respiratory function and sleep quality will be evaluated by giving a 45 degree head height to 30 patients determined by Randomizer.org.

    Also known as: Nursing care intervention for positioning appropriately after surgery

  • Otherthe group with a bed head height of 30 degrees

    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.

    Also known as: Nursing care intervention for positioning appropriately after surgery

06

What researchers measure

Primary outcomes

  1. Periorbital edema score

    This measurement tool has a single question and has options that score between 0-4: 0 points: No periorbital edema 1. point: Mild periorbital edema 2. points: Periorbital edema enlarged towards the iris layer of the eye 3. points: Periorbital edema covering the iris 4. 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

  2. Periorbital edema score

    This measurement tool has a single question and has options that score between 0-4: 0 points: No periorbital edema 1. point: Mild periorbital edema 2. points: Periorbital edema enlarged towards the iris layer of the eye 3. points: Periorbital edema covering the iris 4. 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

  3. Periorbital edema score

    This measurement tool has a single question and has options that score between 0-4: 0 points: No periorbital edema 1. point: Mild periorbital edema 2. points: Periorbital edema enlarged towards the iris layer of the eye 3. points: Periorbital edema covering the iris 4. 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

  4. 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.

    Time frame: 1 hour after surgery

  5. 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.

    Time frame: 4 hours after surgery

  6. 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.

    Time frame: 24th hour after surgery

Secondary outcomes

  1. 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.

    Time frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery

  2. 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.

    Time frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery

  3. 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.

    Time frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery

  4. 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.

    Time frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery

  5. 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.

    Time frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery

  6. 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.

    Time frame: 1 hour after surgery 4 hours after surgery 24th hour after surgery

07

Study locations

1 of 1 sites recruiting
  • Zonguldak Ataturk State Hospital
    Zonguldak, 67030, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05695794
Lead sponsor
Bartın Unıversity
Responsible party
Şevval Polat (Principal Investigator, Bartın Unıversity) — Principal investigator
First posted
Jan 25, 2023
Start date
Dec 8, 2022
Primary completion
Mar 21, 2023 (estimated)
Completion
Jun 2023 (estimated)
Last update
Jan 25, 2023

Study contacts

Polat
Contact
sevvalseyrek74@gmail.com
05388480455
Şevval Polat
Contact
sevvalseyrek74@gmail.com
05388480455
Şevval Polat
principal investigator · Uzunmehmet chest and occupational diseases hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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