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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04674215
Other study ID # YL-20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2, 2019
Est. completion date November 29, 2019

Study information

Verified date December 2020
Source Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the effect on the first mobility of inside bed rotation and mobilization training to patients who will be lumbar disc surgery.


Description:

The purpose of this study is to examine the effect on the first mobility of inside bed rotation and mobilization training to patients who will be lumbar disc surgery. This study Is a randomized controlled clinical trial. The sample of this study consisted of 40 operated with the diagnosis lumbar disc herniation patients that 19 of which were intervention and 21 of which were control patients between January- November 2019. The patients were taken to the table randomization method in the study. While the patients receiving control treatment received routine clinical care, the patients in the intervention group received in- bed rotation and mobilization training with planned training with planned training one day before the operation.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 29, 2019
Est. primary completion date May 23, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Turning in Bed
Preoperative Turning in Bed Training
Mobilization
Preoperative Mobilization Training
Other:
information
Routine Clinical Care

Locations

Country Name City State
Turkey Gulhane Training and Research Hospital, University of Health Sciences Ankara

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Competence during the first postoperative in-bed turning 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)
Primary Pain during the first postoperative in-bed turning 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)
Primary Strain during the first postoperative in-bed turning 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)
Primary Competence during the first postoperative mobilization 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
Primary Pain during the first postoperative mobilization 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
Primary Strain during the first postoperative mobilization 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 The willingness of the patients for mobilization 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
Secondary Anxiety levels of the patients 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
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