Postoperative MobilityNCT04674215
The Effect of Preoperative Turning in Bed and Mobilization Training on the Postoperative First Mobility
A study testing Turning in Bed, Mobilization and information in people with Postoperative Mobility, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Mobility
- What is being tested?
- Turning in Bed, Mobilization and information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2019to 29 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital, University of Health Sciences
Ankara, 06010
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Mobility
- Being tested
- Turning in Bed, Mobilization, information
- Keywords
- Postoperative, Nursing, Lumbar Disk Surgery, Role Playing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turning in BedBehavioural
Also called EDUCATİON
Preoperative Turning in Bed Training
MobilizationBehavioural
Also called EDUCATİON
Preoperative Mobilization Training
informationOther
Routine Clinical Care
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 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. Receives: Behavioral: Turning in Bed; Behavioral: Mobilization; Other: information |
| control group | Other | 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. Receives: Other: information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Operation day (8 hours after surgery)
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.
Measured: Operation day (8 hours after surgery)
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.
Measured: Operation day (8 hours after surgery)
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.
Measured: On the first postoperative day
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.
Measured: On the first postoperative day
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.
Measured: On the first postoperative day
Secondary outcomes (2)
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.
Measured: On the first postoperative day
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.
Measured: On the first postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start2 Jan 2019
- Primary completion23 May 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative MobilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Cinar, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Hatice Akkaya, Study director, Saglik Bilimleri Universitesi Gulhane Tip FakultesiHatice Ayhan, Principal investigator, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674215
- Sponsor's protocol ID
- YL-20
- Status last verified
- Dec 2020
- First submitted
- 6 Oct 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Turning in Bed and Mobilization Training on the Postoperative First Mobility of Patients Who Will Have Lumbar Disc Surgery
- ClinicalTrials.gov ID
- NCT04674215
- Acronym / sponsor ID
- YL-20
- Conditions
- Postoperative Mobility
- Keywords
- Postoperative, Nursing, Lumbar Disk Surgery, Role Playing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Turning in Bed, Behavioral: Mobilization, Other: informationData 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. |
| control group | Other | Other: informationData 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turning in BedAlso: EDUCATİONPreoperative Turning in Bed Training | Behavioural | intervention group |
| MobilizationAlso: EDUCATİONPreoperative Mobilization Training | Behavioural | intervention group |
| informationRoutine Clinical Care | Other | control group, intervention group |
Primary outcome
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.
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.
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.
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.
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.
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.
2 secondary outcomes
The willingness of the patients for mobilization
Time frame: On the first postoperative day
Anxiety levels of the patients
Time frame: On the first postoperative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Should Patients Walk From the Postanesthesia Care Unit to the General Ward After a Lumbar Discectomy? A Randomized StudyLink provided by the sponsor.
- Establishing clinically meaningful severity levels for the Tampa Scale for Kinesiophobia (TSK-13)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatice Akkaya study director
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Hatice Ayhan principal investigator
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turning in Bed, Mobilization and information in people with Postoperative Mobility, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Competence during the first postoperative in-bed turning (time frame: Operation day (8 hours after surgery)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.