NCT05695794

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

December 8, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

November 22, 2022

Last Update Submit

January 23, 2023

Conditions

Rhinoplasty

Keywords

RhinoplastyEdemaEcchymosisRespiratory Function TestsSleep Quality

Outcome Measures

Primary Outcomes (6)

  • 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.

    1 hour after surgery

  • 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.

    4 hours after surgery

  • 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.

    24th hour after surgery

  • 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

  • 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

  • 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 Outcomes (6)

  • Monitoring the change in fever

    1 hour after surgery 4 hours after surgery 24th hour after surgery

  • Monitoring the change in systolic blood pressure

    1 hour after surgery 4 hours after surgery 24th hour after surgery

  • Monitoring the change in diastolic blood pressure

    1 hour after surgery 4 hours after surgery 24th hour after surgery

  • Monitoring the change in pulse

    1 hour after surgery 4 hours after surgery 24th hour after surgery

  • Monitoring the change in oxygen saturation

    1 hour after surgery 4 hours after surgery 24th hour after surgery

  • +1 more secondary outcomes

Study Arms (2)

the group with a bed head height of 45 degrees

OTHER

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

the group with a bed head height of 30 degrees

EXPERIMENTAL

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

the group with a bed head height of 45 degreesOTHER

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
the group with a bed head height of 45 degrees
the group with a bed head height of 30 degreesOTHER

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
the group with a bed head height of 30 degrees

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Ataturk State Hospital

Zonguldak, 67030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

EdemaEcchymosisSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagePathologic ProcessesSkin ManifestationsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Şevval Polat

    Uzunmehmet chest and occupational diseases hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Polat

CONTACT

05388480455sevvalseyrek74@gmail.com

Şevval Polat

CONTACT

05388480455sevvalseyrek74@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: experimental group and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2022

First Posted

January 25, 2023

Study Start

December 8, 2022

Primary Completion

March 21, 2023

Study Completion

June 1, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)