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OpenTrials
Completed

NCT Number: NCT07459985

Running Title: Standardized Care After Back Surgery

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.

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Key information

Conditions

Back Surgery Back Pain Disabilities Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hawler Teaching Hospital

Erbil, Kurdistan Region, 44001, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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