The Effect of Preoperative Turning in Bed and Mobilization Training on the Postoperative First Mobility

December 18, 2020 updated by: Hatice Cinar, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

The Effect of Preoperative Turning in Bed and Mobilization Training on the Postoperative First Mobility of Patients Who Will Have Lumbar Disc Surgery

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06010
        • Gulhane Training and Research Hospital, University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • EDUCATİON
Preoperative Mobilization Training
Other Names:
  • EDUCATİON
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
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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2019

Primary Completion (ACTUAL)

May 23, 2019

Study Completion (ACTUAL)

November 29, 2019

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (ACTUAL)

December 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 18, 2020

Last Verified

December 1, 2020

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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