Running Title: Standardized Care After Back Surgery

NCT07459985 | Completed DMC

• 1 other identifier: 2435, HawlerMUErbil
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to examine the effectiveness of a standardized care program on pain, disability, and patient knowledge among postoperative back-surgery patients in Erbil, Iraq.

Conditions

Back Surgery; Pain; Back Pain; Disabilities

Keywords

Back surgery, Standardized care, Pain, Disability, Knowledge, Postoperative outcomes

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity Score

  Pain intensity was measured using the Universal Pain Assessment Tool (0-10 numeric rating scale). Higher scores indicate greater pain severity. The primary endpoint is the change in pain score from baseline (pre-intervention) to 8 weeks postoperatively.

  Baseline and 8 weeks postoperatively

Secondary Outcomes (1)

• Change in Functional Disability Score

  Baseline and 8 weeks postoperatively

Other Outcomes (3)

• Change in Patient Knowledge Score

  Baseline and 8 weeks postoperatively

• Patient Satisfaction with Postoperative Care

  8 weeks postoperatively

• Incidence of Postoperative Complications

  From surgery to 8 weeks postoperatively

Study Arms (2)

Standardized Care After Back Surgery

EXPERIMENTAL

Participants in this arm receive a structured standardized care program in addition to routine postoperative management following lumbar spine surgery. The program includes individualized patient education regarding pain management, wound care, early mobilization, activity modification, body mechanics, medication adherence, prevention of complications, and follow-up instructions. Educational materials and verbal instructions are provided preoperatively and reinforced postoperatively to improve pain outcomes, functional recovery, knowledge, and satisfaction.

Behavioral: Standardized Educational Care Program

Routine Postoperative Care

NO INTERVENTION

Participants in this arm receive routine postoperative hospital care following lumbar spine surgery without the structured standardized educational care program.

Interventions

Standardized Educational Care Program BEHAVIORAL

A structured, standardized educational care program is delivered to patients undergoing lumbar spine surgery. The program includes preoperative and postoperative education on pain management, wound care, early mobilization, activity modification, proper body mechanics, medication adherence, prevention of complications, and discharge instructions. Education is provided verbally and through written materials.

Standardized Care After Back Surgery

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between 18 and 60 years of age, of either sex, scheduled for elective thoracic (T1) to lumbar (L5) spine surgery, able to communicate in Kurdish or Arabic, and capable of providing informed consent. Only those willing to complete all follow-up assessments were enrolled to ensure complete data collection.

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Hawler Teaching Hospital

Erbil, Kurdistan Region, 44001, Iraq

Location

MeSH Terms

Conditions

Pain; Back Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vian Afan Naqshbandi, PhD

  Hawler Medical University/College of nursing, Erbil, Kurdistan Region, Iraq

  STUDY DIRECTOR

• Nuraddin Hamad Mhammad, PhD

  Hawler Medical University/ College of Medicine, Erbil, Kurdistan Region, Iraq

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Effect of a Standardized Care Program on Pain, Disability, and Knowledge Among Postoperative Back Surgery Patients in Erbil

Model Details: This is a non-randomized, parallel-group interventional study comparing a standardized educational care program versus routine postoperative care among patients undergoing lumbar spine surgery.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: September 29, 2024
• Primary Completion: April 25, 2025
• Study Completion: September 20, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

IR (1)