Back SurgeryNCT07459985
Running Title: Standardized Care After Back Surgery
A study testing Standardized Educational Care Program in people with Back Surgery and Pain, run by Hawler Medical University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Back Surgery, Pain, Back Pain
- What is being tested?
- Standardized Educational Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIraq
- Study dates
- 29 Sep 2024to 20 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Back Surgery, Pain, Back Pain, Disabilities
- Being tested
- Standardized Educational Care Program
- Keywords
- Back surgery, Standardized care, Pain, Disability, Knowledge, Postoperative outcomes
- Medical subject headings
- Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Educational Care ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 8 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start29 Sep 2024
- Primary completion25 Apr 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sideeq Sadir Ali, Hawler Medical University
- Investigators
- Vian Afan Naqshbandi, PhD, Study director, Hawler Medical University/College of nursing, Erbil, Kurdistan Region, IraqNuraddin Hamad Mhammad, PhD, Study chair, Hawler Medical University/ College of Medicine, Erbil, Kurdistan Region, Iraq
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459985
- Sponsor's protocol ID
- 2435, HawlerMUErbil
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Naqshbandi VA, Ali SS, Mhammad NH, Saber AF. A Standardized Perioperative Care Program and Postoperative Pain, Disability, and Knowledge Among Patients Undergoing Lumbar Spine Surgery in Erbil, Iraq: A Non-Randomized Controlled Study. Health Sci Rep. 2026 Sep 9;9(9):e73213. doi: 10.1002/hsr2.73213. eCollection 2026 Sep.
PubMed 42719606
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Standardized Care Program on Pain, Disability, and Knowledge Among Postoperative Back Surgery Patients in Erbil
- ClinicalTrials.gov ID
- NCT07459985
- Acronym / sponsor ID
- 2435, HawlerMUErbil
- Conditions
- Back Surgery, Pain, Back Pain, Disabilities
- Keywords
- Back surgery, Standardized care, Pain, Disability, Knowledge, Postoperative outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 29 Sep 2024 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standardized Care After Back Surgery | Experimental | Behavioral: Standardized Educational Care ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Educational Care ProgramA 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. | Behavioural | Standardized Care After Back Surgery |
Primary outcome
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.
1 secondary outcome
Change in Functional Disability Score
Time frame: Baseline and 8 weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Derived from this study: PubMed 42719606Naqshbandi VA, Ali SS, Mhammad NH, Saber AF. A Standardized Perioperative Care Program and Postoperative Pain, Disability, and Knowledge Among Patients Undergoing Lumbar Spine Surgery in Erbil, Iraq: A Non-Randomized Controlled Study. Health Sci Rep. 2026 Sep 9;9(9):e73213. doi: 10.1002/hsr2.73213. eCollection 2026 Sep.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Educational Care Program in people with Back Surgery and Pain, run by Hawler Medical University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity Score (time frame: Baseline and 8 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07459985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.