CClinicalTrials.gg
CompletedNCT07459985Updated Mar 10, 2026

Running Title: Standardized Care After Back Surgery

An interventional study of Standardized Educational Care Program in Back Surgery, Pain and Back Pain, sponsored by Hawler Medical University. Completed at 1 site in Iraq. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Hawler Medical University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Sep 2024, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Back Surgery
  • Pain
  • Back Pain
  • Disabilities

Browse trials for

Keywords

  • Back surgery, Standardized care, Pain, Disability, Knowledge, Postoperative outcomes
03

In context

Pain

2,219 studies on the registry are indexed under Pain; 917 are open to participants now.

This study's enrollment of 70 is close to the median of 70 across 1,904 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Hawler Medical University is the lead sponsor of 56 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralStandardized 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.

06

What researchers measure

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.

    Time frame: Baseline and 8 weeks postoperatively

Secondary outcomes

  1. Change in Functional Disability Score

    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.

    Time frame: Baseline and 8 weeks postoperatively

Other outcomes

  1. Change in Patient Knowledge Score

    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.

    Time frame: Baseline and 8 weeks postoperatively

  2. Patient Satisfaction with Postoperative Care

    Postoperative satisfaction was assessed using a structured patient satisfaction questionnaire. Higher scores indicate greater satisfaction with care and the recovery process.

    Time frame: 8 weeks postoperatively

  3. Incidence of Postoperative Complications

    Occurrence of postoperative complications such as wound infection, delayed healing, or readmission during the follow-up period.

    Time frame: From surgery to 8 weeks postoperatively

07

Study locations

1 site
  • Hawler Teaching Hospital
    Erbil, Kurdistan Region 44001, Iraq
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07459985
Lead sponsor
Hawler Medical University
Responsible party
Sideeq Sadir Ali (The Effect of a Standardized Care Program on Pain, Disability, and Knowledge Among Postoperative Back Surgery Patients in Erbil, Hawler Medical University) — Principal investigator
First posted
Mar 10, 2026
Start date
Sep 29, 2024
Primary completion
Apr 25, 2025
Completion
Sep 20, 2025
Last update
Mar 10, 2026

Study contacts

Vian Afan Naqshbandi, PhD
study director · Hawler Medical University/College of nursing, Erbil, Kurdistan Region, Iraq
Nuraddin Hamad Mhammad, PhD
study chair · Hawler Medical University/ College of Medicine, Erbil, Kurdistan Region, Iraq

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion