NCT07107360

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 30, 2025

Last Update Submit

July 30, 2025

Conditions

Keywords

pain neuroscience educationpreoperative anxietyrecoveryorthopaedic surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    Assessments were performed at two time points: one hour prior to surgery and one month after surgery.

Study Arms (2)

Pain Neuroscience Education Group

EXPERIMENTAL

received pain neuroscience education in addition to conventional preoperative education

Other: Pain Neuroscience Education

Control Group

ACTIVE COMPARATOR

received conventional preoperative education

Other: Conventional preoperative education

Interventions

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.

Pain Neuroscience Education Group

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.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Atlas University

Istanbul, Kagıthane, 34413, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asst. prof.

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 6, 2025

Study Start

January 6, 2025

Primary Completion

May 15, 2025

Study Completion

May 15, 2025

Last Updated

August 6, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations