Orthopaedic SurgeryNCT07107360
The Effect of Pain Neuroscience Education on Preoperative Anxiety and Postoperative Recovery in Patients Scheduled for Orthopedic Surgery
A study testing Pain Neuroscience Education and Conventional preoperative education in people with Orthopaedic Surgery and Upper Extremity, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effects of preoperative PNE on preoperative anxiety, pain-related beliefs, and postoperative functional outcomes in patients undergoing upper extremity orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orthopaedic Surgery, Upper Extremity
- What is being tested?
- Pain Neuroscience Education and Conventional preoperative education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2025to 15 May 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 18 and 65 years
- scheduled for upper extremity orthopedic surgery; able to communicate effectively (i.e., speaks Turkish fluently,
- understands verbal and written instructions, and has no speech impairments);
- willing to voluntarily participate in the study.
Who cannot join
- any mental or cognitive impairments
- currently using medication for anxiety or related conditions
- taking painkillers regularly
- have undergone any surgical procedures within the past year.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Atlas University
Istanbul, Kagıthane, 34413
About this study
Official title: Pain Neuroscience Education for Patients Undergoing Orthopaedic Surgery: Exploring Preoperative Anxiety and Improving Postoperative Recovery
This study aimed to investigate the effects of preoperative PNE on preoperative anxiety, pain-related beliefs, and postoperative functional outcomes in patients undergoing upper extremity orthopedic surgery.
Read the detailed description
This study was designed as a single-blind, randomized controlled trial. It was conducted in accordance with the Declaration of Helsinki, adhering to ethical principles for medical research involving human participants. The study was completed with a total of 33 participants aged between 18 and 65 years who were scheduled for upper extremity surgery. Participants were randomly assigned to either the pain neuroscience education group or the control group.
The inclusion criteria were as follows: aged between 18 and 65 years; scheduled for upper extremity orthopedic surgery; able to communicate effectively (i.e., speaks Turkish fluently, understands verbal and written instructions, and has no speech impairments); and willing to voluntarily participate in the study.
Participants were excluded from the study if they met any of the following conditions: mental or cognitive impairments; are currently using medication for anxiety or related conditions; taking painkillers regularly; or have undergone any surgical procedures within the past year.
- Conditions
- Orthopaedic Surgery, Upper Extremity
- Being tested
- Pain Neuroscience Education, Conventional preoperative education
- Keywords
- pain neuroscience education, preoperative anxiety, recovery, orthopaedic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationOther
The study included two groups, consisting of participants who met the inclusion criteria and adhered to the procedures. Participants in the intervention group received a 20-minute Pain Neuroscience Education (PNE) session delivered face-to-face one hour prior to their scheduled surgery. The PNE focused on the biopsychosocial aspects of pain and included both theoretical and practical strategies for postoperative pain management.
Conventional preoperative educationOther
Participants in the experimental group received pain neuroscience education, while participants in the control group received a booklet summarizing this education in addition to routine preoperative care.
| Study group | Role | What they receive |
|---|---|---|
| Pain Neuroscience Education Group | Experimental | received pain neuroscience education in addition to conventional preoperative education Receives: Other: Pain Neuroscience Education |
| Control Group | Active comparator | received conventional preoperative education Receives: Other: Conventional preoperative education |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain-related beliefs
Pain Catastrophizing: The Pain Catastrophizing Scale (PCS) was developed in 1995 by Michael J. L. Sullivan and colleagues (Sullivan et al., 1995). The PCS is a 13-item self-report measure that assesses the extent of catastrophizing in the context of actual or anticipated pain. It conceptualizes catastrophizing as a multidimensional construct, measured across three subscales: rumination, magnification, and helplessness. Rumination refers to the tendency to focus on pain-related thoughts, helplessness reflects a perceived inability to cope with painful situations, and magnification represents an exaggerated interpretation of the threat value of pain.
Measured: Assessments were performed at two time points: one hour prior to surgery and one month after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start6 Jan 2025
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SOzkan, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107360
- Sponsor's protocol ID
- Pain Neuroscience Education
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuroscience Education for Patients Undergoing Orthopaedic Surgery: Exploring Preoperative Anxiety and Improving Postoperative Recovery
- ClinicalTrials.gov ID
- NCT07107360
- Acronym / sponsor ID
- Pain Neuroscience Education
- Conditions
- Orthopaedic Surgery, Upper Extremity
- Keywords
- pain neuroscience education, preoperative anxiety, recovery, orthopaedic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 6 Aug 2025 (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 investigate the effects of preoperative PNE on preoperative anxiety, pain-related beliefs, and postoperative functional outcomes in patients undergoing upper extremity orthopedic surgery.
Detailed description
This study was designed as a single-blind, randomized controlled trial. It was conducted in accordance with the Declaration of Helsinki, adhering to ethical principles for medical research involving human participants. The study was completed with a total of 33 participants aged between 18 and 65 years who were scheduled for upper extremity surgery. Participants were randomly assigned to either the pain neuroscience education group or the control group.
The inclusion criteria were as follows: aged between 18 and 65 years; scheduled for upper extremity orthopedic surgery; able to communicate effectively (i.e., speaks Turkish fluently, understands verbal and written instructions, and has no speech impairments); and willing to voluntarily participate in the study.
Participants were excluded from the study if they met any of the following conditions: mental or cognitive impairments; are currently using medication for anxiety or related conditions; taking painkillers regularly; or have undergone any surgical procedures within the past year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Neuroscience Education Group | Experimental | Other: Pain Neuroscience Educationreceived pain neuroscience education in addition to conventional preoperative education |
| Control Group | Active comparator | Other: Conventional preoperative educationreceived conventional preoperative education |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged between 18 and 65 years
- scheduled for upper extremity orthopedic surgery; able to communicate effectively (i.e., speaks Turkish fluently,
- understands verbal and written instructions, and has no speech impairments);
- willing to voluntarily participate in the study.
Key exclusion criteria (4 listed)
- any mental or cognitive impairments
- currently using medication for anxiety or related conditions
- taking painkillers regularly
- have undergone any surgical procedures within the past year.
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 |
|---|---|---|
| Pain Neuroscience EducationThe study included two groups, consisting of participants who met the inclusion criteria and adhered to the procedures. Participants in the intervention group received a 20-minute Pain Neuroscience Education (PNE) session delivered face-to-face one hour prior to their scheduled surgery. The PNE focused on the biopsychosocial aspects of pain and included both theoretical and practical strategies for postoperative pain management. | Other | Pain Neuroscience Education Group |
| Conventional preoperative educationParticipants in the experimental group received pain neuroscience education, while participants in the control group received a booklet summarizing this education in addition to routine preoperative care. | Other | Control Group |
Primary outcome
pain-related beliefs
Time frame: Assessments were performed at two time points: one hour prior to surgery and one month after surgery.
Pain Catastrophizing: The Pain Catastrophizing Scale (PCS) was developed in 1995 by Michael J. L. Sullivan and colleagues (Sullivan et al., 1995). The PCS is a 13-item self-report measure that assesses the extent of catastrophizing in the context of actual or anticipated pain. It conceptualizes catastrophizing as a multidimensional construct, measured across three subscales: rumination, magnification, and helplessness. Rumination refers to the tendency to focus on pain-related thoughts, helplessness reflects a perceived inability to cope with painful situations, and magnification represents an exaggerated interpretation of the threat value of pain.
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 6 Aug 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education and Conventional preoperative education in people with Orthopaedic Surgery and Upper Extremity, run by Atlas University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 6 Aug 2025. 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 Turkey (Türkiye). 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?
pain-related beliefs (time frame: Assessments were performed at two time points: one hour prior to surgery and one month after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2025.