Running Title: Standardized Care After Back Surgery

March 4, 2026 updated by: Sideeq Sadir Ali, Hawler Medical University

The Effect of a Standardized Care Program on Pain, Disability, and Knowledge Among Postoperative Back Surgery Patients in Erbil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • Kurdistan Region
      • Erbil, Kurdistan Region, Iraq, 44001
        • Hawler Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients who were admitted for emergency procedures, or had cognitive impairments that could interfere with comprehension of instructions. Additional exclusion criteria included revision or second-time back surgeries and severe comorbid conditions, such as limb fractures or other major mobility-limiting issues that could affect postoperative recovery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standardized Care After Back Surgery
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
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.
No Intervention: Routine Postoperative Care
Participants in this arm receive routine postoperative hospital care following lumbar spine surgery without the structured standardized educational care program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity Score
Time Frame: Baseline and 8 weeks postoperatively
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Disability Score
Time Frame: Baseline and 8 weeks postoperatively
Functional disability assessed using the Oswestry Low Back Disability Questionnaire (0-100 scale). Higher scores indicate greater disability. The outcome is the change from baseline to 8 weeks after surgery.
Baseline and 8 weeks postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Knowledge Score
Time Frame: Baseline and 8 weeks postoperatively
Patient knowledge regarding postoperative self-care, pain management, activity modification, and complication prevention measured using a structured knowledge questionnaire developed for the study. Higher scores indicate greater knowledge. The outcome is the change from baseline to 8 weeks.
Baseline and 8 weeks postoperatively
Patient Satisfaction with Postoperative Care
Time Frame: 8 weeks postoperatively
Postoperative satisfaction was assessed using a structured patient satisfaction questionnaire. Higher scores indicate greater satisfaction with care and the recovery process.
8 weeks postoperatively
Incidence of Postoperative Complications
Time Frame: From surgery to 8 weeks postoperatively
Occurrence of postoperative complications such as wound infection, delayed healing, or readmission during the follow-up period.
From surgery to 8 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hawler Medical University

Investigators

  • Study Director: Vian Afan Naqshbandi, PhD, Hawler Medical University/College of nursing, Erbil, Kurdistan Region, Iraq
  • Study Chair: Nuraddin Hamad Mhammad, PhD, Hawler Medical University/ College of Medicine, Erbil, Kurdistan Region, Iraq

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2024

Primary Completion (Actual)

April 25, 2025

Study Completion (Actual)

September 20, 2025

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2435, HawlerMUErbil

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Standardized Educational Care Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe