The Effect of Mobilization Protocol Assisted With Simulated Clinical Immersion Videos on Patients Undergoing Lumbar Spine Surgery

NCT05462210 | Completed

• 1 other identifier: KAEK-312
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study focused on examining the effect of mobilization protocol assisted with simulated clinical immersion videos on postoperative pain, fear of movement, mobility level and satisfaction in patients undergoing lumbar spine surgery.

Conditions

Lumbar Spine Surgery; Lumbar Disc Herniation

Keywords

Mobilization; Nursing; Spinal Surgery; Pain; Fear of Movement; Patient Satisfaction; Simulation

Outcome Measures

Primary Outcomes (3)

• Back and leg pain

  The Visual Analog Scale (VAS) is a straight horizontal line of 100 mm. One end describes no paint at all while the other describes an excessive amount of pain. VAS score is calculated by measuring in millimeters from the left end of the line to the point marked by the patient. VAS will be used to assess low back pain (VAS-BP) and right and left leg pain (VAS-LP) separately (Nayak, Coats, Abdullah, Stein, \& Malhotra, 2015).

  Changes in hospitalization, first mobilization after surgery and the day of discharge. 1. Day of hospitalization (24 hours) 2. The first 24 hours after surgery 3. The day of discharge (24 hours)

• Fear of Movement

  Tampa Scale for Kinesiophobia (TKS): The TKS is used to assess the subjective degree of kinesiophobia or fear of movement, and consists of 17 items. The 4-point Likert-type scale ranges from 1 to 4 (1=Strongly disagree, 4=Completely agree). The overall score is calculated after reverse scoring the items 4, 8, 12 and 16. The overall scale score ranges between 17 and 68, and higher scores indicate higher level of kinesiophobia (Yılmaz et al., 2011).

  Changes in hospitalization, first mobilization after surgery and the day of discharge. 1. Day of hospitalization (24 hours) 2. The first 24 hours after surgery 3. The day of discharge (24 hours)

• Mobility Level

  Patient Mobility Scale: The level of pain and difficulty that patients experience doing four activities (turning from side to side in bed, sitting on the edge of the bed, sitting up at the side of the bed, walking in hospital room) during the postoperative period are assessed using a 15-cm visual analogue, throughout which verbal expressions are included. The lowest and highest possible scores obtained from each item ranges between 0 and 15, and the overall scale score ranges between 0 and 120. Higher scores indicate higher level of pain and difficulty (Ayoğlu, 2011).

  Changes in hospitalization, first mobilization after surgery and the day of discharge. 1. Day of hospitalization (24 hours) 2. The first 24 hours after surgery 3. The day of discharge (24 hours)

Secondary Outcomes (1)

• Patient Satisfaction

  The day of discharge (24 hours)

Study Arms (2)

Control group

NO INTERVENTION

The first mobilization of patients undergoing surgical treatment for lumbar disc herniation in the clinics where the study will be conducted is routinely performed within the first 24 hours after surgery. When the data collection process of the control group is completed, the data will be integrated with the mobilization protocol assisted with simulated clinical immersion videos created for the research.

Intervention group

EXPERIMENTAL

Mobilization Protocol Assisted with Simulated Clinical Immersion Videos Simulated clinical immersion videos created for the mobilization protocol for patients in the intervention group will be sent to their smartphones once they are admitted to the clinic. The videos prepared within the scope of the mobilization protocol will be watched by patients in company with the researcher the day before the operation, their questions will be answered, and the correct mobilization techniques will be shown practically. It is expected that patients watch the videos at least four times, as twice with the researcher and twice by themselves.

Other: Mobilization Protocol Assisted with Simulated Clinical Immersion Videos

Interventions

Mobilization Protocol Assisted with Simulated Clinical Immersion Videos OTHER

Mobilization Protocol Assisted with Simulated Clinical Immersion Videos Simulated clinical immersion videos created for the mobilization protocol for patients in the intervention group will be sent to their smartphones once they are admitted to the clinic. The videos prepared within the scope of the mobilization protocol will be watched by patients in company with the researcher the day before the operation, their questions will be answered, and the correct mobilization techniques will be shown practically. It is expected that patients watch the videos at least four times, as twice with the researcher and twice by themselves.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• According to the ICD-10 Codes: Those with S33.0-Traumatic rupture of lumbar intervertebral disc, G55-Nerve root and plexus compressions, M54.4-Lumbago with sciatica, underwent lumbar disc herniation surgery (microdiscectomy) due to diagnosed with M54.5-Low back pain,
• Aged 18 and over,
• With no hearing, vision, comprehension and speech impairments,
• Volunteering to participate in the research,
• Using a smartphone will be included in the study.

You may not qualify if:

• Those under the age of 18,
• Underwent revision lumbar spine surgery,
• With mental or physical disabilities to receive the mobilization training that will be provided before the operation will not be included in the sample.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, 07058, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Pain; Kinesiophobia; Patient Satisfaction

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants and statistician are blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 18, 2022
• Study Start: January 11, 2022
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

TU (1)