NCT04674215

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

October 6, 2020

Last Update Submit

December 18, 2020

Conditions

Keywords

PostoperativeNursingLumbar Disk SurgeryRole Playing

Outcome Measures

Primary Outcomes (6)

  • 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)

  • 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)

  • 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)

  • 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

  • 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

  • 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 Outcomes (2)

  • The willingness of the patients for mobilization

    On the first postoperative day

  • Anxiety levels of the patients

    On the first postoperative day

Study Arms (2)

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.

Behavioral: Turning in BedBehavioral: MobilizationOther: 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.

Other: information

Interventions

Turning in BedBEHAVIORAL

Preoperative Turning in Bed Training

Also known as: EDUCATİON
intervention group
MobilizationBEHAVIORAL

Preoperative Mobilization Training

Also known as: EDUCATİON
intervention group

Routine Clinical Care

control groupintervention group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Training and Research Hospital, University of Health Sciences

Ankara, 06010, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Interventions

BedsEducational Status

Intervention Hierarchy (Ancestors)

Equipment and Supplies, HospitalEquipment and SuppliesSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Hatice Akkaya

    Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

    STUDY DIRECTOR
  • Hatice Ayhan

    Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral student/Nurse/Principal Investigator

Study Record Dates

First Submitted

October 6, 2020

First Posted

December 19, 2020

Study Start

January 2, 2019

Primary Completion

May 23, 2019

Study Completion

November 29, 2019

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations