- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04674215
The Effect of Preoperative Turning in Bed and Mobilization Training on the Postoperative First Mobility
The Effect of Preoperative Turning in Bed and Mobilization Training on the Postoperative First Mobility of Patients Who Will Have Lumbar Disc Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey, 06010
- Gulhane Training and Research Hospital, University of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being over the age of 18,
- Being literate in Turkish,
- Being in the ASA(American Society of Anesthesiologists) 1,2 and 3 classification,
- Having surgery for the first time due to lumber disc herniation and volunteering to participate in the research.
Exclusion Criteria:
- Having a mental or physical disability to prevent in-bed rotation and mobilization training to be given before surgery,
- to get a score above 16 from the Observer Mobility Scale before surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: intervention group
Data about sociodemographic and clinical characteristics of the patients in all groups were collected. Their mobility status and general anxiety levels were evaluated. The patients in the intervention group were given a planned "in-bed turning and mobilization training" in the patient's room by the researcher one day before the surgery. This training included explaining the importance of postoperative mobility, demonstrating the correct in-bed turning and mobilization steps through pictures with the "Illustrated In-Bed Turning and Mobilization Training Material", answering questions (if any), and finally, simulating postoperative in-bed turning and the first mobilization using the role-playing technique in collaboration with the patient. |
Preoperative Turning in Bed Training
Other Names:
Preoperative Mobilization Training
Other Names:
Routine Clinical Care
|
OTHER: control group
Data about sociodemographic and clinical characteristics of the patients in all groups were collected. Their mobility status and general anxiety levels were evaluated. Patients in the control group received routine clinical care. This care included the provision of verbal information to the patient at different times by the primary physician and/or nurse about postoperative in-bed turning and mobilization and answering questions if any. |
Routine Clinical Care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Competence during the first postoperative in-bed turning
Time Frame: Operation day (8 hours after surgery)
|
The patient's first postoperative in-bed turning, the intensive care nurse scored the patient's dependence-independence status/degree with the in-bed turning section of the Observer Mobility Scale.
The Observer Mobility Scale: During the same four activities following the surgery, the patient's dependence-independence status on the nurse is scored between "1- performing the activity independently" and "5-inability to perform the activity despite help".
The score that can be obtained from each item varies between 1 and 5, and the total scale score ranges from 4 to 20.
Increased scores indicate inadequate movement skills.
|
Operation day (8 hours after surgery)
|
Pain during the first postoperative in-bed turning
Time Frame: Operation day (8 hours after surgery)
|
The patient scored the degree of the pain during in-bed turning with the related section of the Patient Mobility Scale.
The Patient Mobility Scale: The level of pain and difficulty experienced during four activities performed after surgery is evaluated using a 15-cm-wide visual analog.
The score that can be obtained from each item varies between 0-15, and the total scale score ranges from 0 to 120.
Increased scores indicate an increased level of pain related to the activity.
|
Operation day (8 hours after surgery)
|
Strain during the first postoperative in-bed turning
Time Frame: Operation day (8 hours after surgery)
|
The patient scored the degree of the strain during in-bed turning with the related section of the Patient Mobility Scale.
The Patient Mobility Scale: The level of pain and difficulty experienced during four activities performed after surgery is evaluated using a 15-cm-wide visual analog.
The score that can be obtained from each item varies between 0-15, and the total scale score ranges from 0 to 120.
Increased scores indicate an increased level of difficulty related to the activity.
|
Operation day (8 hours after surgery)
|
Competence during the first postoperative mobilization
Time Frame: On the first postoperative day
|
Following the mobilization, the intensive care nurse evaluated the patient's dependence-independence status/degree during the mobilization steps with the Observer Mobility Scale.
The Observer Mobility Scale: During the same four activities following the surgery, the patient's dependence-independence status on the nurse is scored between "1- performing the activity independently" and "5-inability to perform the activity despite help".
The score that can be obtained from each item varies between 1 and 5, and the total scale score ranges from 4 to 20.
Increased scores indicate inadequate movement skills.
|
On the first postoperative day
|
Pain during the first postoperative mobilization
Time Frame: On the first postoperative day
|
Following the mobilization, the patient evaluated the degree of pain during mobilization with the Patient Mobility Scale.
The Patient Mobility Scale: The level of pain and difficulty experienced during four activities performed after surgery is evaluated using a 15-cm-wide visual analog.
The score that can be obtained from each item varies between 0-15, and the total scale score ranges from 0 to 120.
Increased scores indicate an increased level of pain related to the activity.
|
On the first postoperative day
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Strain during the first postoperative mobilization
Time Frame: On the first postoperative day
|
Following the mobilization, the patient evaluated the degree of the strain during mobilization with the Patient Mobility Scale.
The Patient Mobility Scale: The level of pain and difficulty experienced during four activities performed after surgery is evaluated using a 15-cm-wide visual analog.
The score that can be obtained from each item varies between 0-15, and the total scale score ranges from 0 to 120.
Increased scores indicate an increased level of pain related to the activity.
|
On the first postoperative day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The willingness of the patients for mobilization
Time Frame: On the first postoperative day
|
Their willingness for mobilization was evaluated by the intensive care nurse just before the first mobilization by asking the patients and using the Numeric Rating Scale.
The scores on the scale range between "0 - I'm not ready for mobilization" and "10 - I feel ready for mobilization" regarding the pre-mobilization willingness.
|
On the first postoperative day
|
Anxiety levels of the patients
Time Frame: On the first postoperative day
|
Mobilization-related anxiety levels of the patients were evaluated with the Spielberger State Anxiety Inventory filled out by the patient just before and after the first mobilization.
The state anxiety scale consists of 20 items.
It evaluates the feelings or behaviors experienced by the individual at a certain time or under certain conditions.
The trait anxiety scale, on the other hand, requires the individual to describe how they generally feel.
It consists of 20 items.
The score that can be obtained from the scale ranges between 20 and 80.
A high score indicates a high level of anxiety.
|
On the first postoperative day
|
Collaborators and Investigators
Investigators
- Study Director: Hatice Akkaya, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Principal Investigator: Hatice Ayhan, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- YL-20
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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