NCT06770387

Brief Summary

Post-operative care for Lumbar Disc Herniation (LDH) is important to reduce postoperative complications. The transition from hospital to home after discharge is important for LDH patients, as the transition process is flawless, the necessary care is provided appropriately, and follow-up is important. The aim of the study is to determine the effects of transitional model-based telenursing and mobile application-based follow-up on fall risk, post-discharge recovery, mobility, anxiety, and complications in patients who underwent lumbar disc surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

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

December 24, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

December 27, 2024

Last Update Submit

September 9, 2025

Conditions

Keywords

mHealthtelenursingtransitional carelumbar disc surgerycomplications

Outcome Measures

Primary Outcomes (3)

  • Complication

    developing complications

    From enrollment to the end of treatment at 1 weeks

  • Rehospitalization

    hospitalization in the postoperative period

    From enrollment to the end of treatment at 1 weeks

  • Readmission

    admission to hospital in the postoperative period

    From enrollment to the end of treatment at 1 weeks

Secondary Outcomes (3)

  • Measuring recovery status with the Post-Discharge Surgical Recovery Scale

    From enrollment to the end of treatment at 4 weeks

  • mobilization

    From enrollment to the end of treatment at 4 weeks

  • Measurement of anxiety status with the hospital anxiety depression scale

    From enrollment to the end of treatment at 4 weeks

Study Arms (2)

Control Group

NO INTERVENTION

No intervention, only routin care

Intervention Group

EXPERIMENTAL

Telenursing and mHealth intervention

Behavioral: mhealth

Interventions

mhealthBEHAVIORAL

mobile application for postoperative period

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Patients who are 18 years of age or older,
  • Can speak and understand Turkish,
  • Have no hearing, understanding, vision or speech problems,
  • Have undergone LDH surgery for the first time,
  • Have undergone LDH surgery with the open method,
  • Have not been diagnosed with depression or anxiety disorder before surgery and are not taking medication for this purpose,
  • Have a smart mobile phone suitable for taking photos or for those close to them,
  • Have not developed serious complications that would delay their discharge from the hospital,
  • Volunteer to participate in the study will be included in the study.

You may not qualify if:

  • Patients who wish to withdraw from the study at any stage after voluntarily participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Deva Hospital

Gaziantep, 27027, Turkey (Türkiye)

Location

Gaziantep University Şahinbey Research and Application Hospital

Gaziantep, 27027, Turkey (Türkiye)

Location

Medical Point Hospital

Gaziantep, 27027, Turkey (Türkiye)

Location

Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital

Kahramanmaraş, 46046, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 27, 2024

First Posted

January 13, 2025

Study Start

December 24, 2024

Primary Completion

May 30, 2025

Study Completion

May 30, 2025

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations