Effect of Preoperative Pain Education on Anxiety, Pain, and Analgesic Use in Total Knee and Hip Replacement Patients (Pain-Anxiety)

January 14, 2026 updated by: Ceren Ustun, Yeditepe University

The Effect of Pain Education Given to Patients Before Total Knee and Hip Replacement Surgery on Anxiety, Pain and Analgesic Use: A Randomized Controlled Study

This randomized controlled trial evaluates whether a standardized preoperative pain education session delivered by a nurse reduces postoperative pain intensity and surgical anxiety among adult elective orthopedic surgery patients compared with usual care.

Primary outcome is postoperative pain at 24 hours. Secondary outcomes include anxiety, analgesic consumption, patient satisfaction, and length of stay

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Adult patients scheduled for elective orthopedic surgery will be randomized (1:1) to receive either (a) a structured 20-30-minute preoperative pain education session plus booklet and video, or (b) usual care alone. Pain intensity measured with NRS at 1, 6,12, 24, 48h postop; analgesics recorded Day 0, 1, 2; preop anxiety measured with Surgical Anxiety Scale in both groups. Intention-to-treat analysis.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Kayişdaği
      • Istanbul, Kayişdaği, Turkey (Türkiye)
        • Yeditepe Üniversitesi Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Being 18 years of age or older,
  • Providing voluntary informed consent to participate in the study,
  • Scheduled to undergo elective knee or hip joint replacement (arthroplasty) surgery,
  • Having no communication barriers,
  • Having no history of alcohol or substance dependence,
  • Having no concurrent diagnosis of malignant disease and not receiving cancer treatment,
  • Not using opioid medications regularly in the preoperative period,
  • Having an ASA score of III or below,
  • Having no cognitive impairment that would affect the ability to comprehend the provided education,
  • Having no diagnosed neurological or psychiatric disorder and not using medications related to such conditions.

Exclusion criteria:

- Patients who do not meet the specified inclusion criteria will not be included in the study.

Elimination criteria:

  • Indication for postoperative intensive care,
  • Development of major complications after surgery, such as massive bleeding or pulmonary embolism,
  • Requesting to withdraw from the study at any stage,
  • Use of a patient-controlled analgesia device postoperatively

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Pain Education
Other: Pain education
education booklet and video
No Intervention: Control Group
No education no video

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Is there a difference in postoperative pain levels between the intervention group, which received preoperative pain education, and the control group, which did not receive preoperative pain education?"
Time Frame: Pain assessment was evaluated at 1, 6, 12, 24, and 48 hours postoperatively.
The intervention group received a preoperative pain education booklet and watched a pain education video, while the control group did not receive any educational intervention. Both groups were asked to rate their pain on the Numerical Rating Scale (NRS) from 0 to 10 at 1, 6, 12, 24, and 48 hours postoperatively, where 0 indicated no pain (a good score) and 10 indicated the worst possible pain (a poor score). Since pain is subjective, the patients' self-reported scores were recorded as provided. The differences between the two groups were subsequently analyzed.
Pain assessment was evaluated at 1, 6, 12, 24, and 48 hours postoperatively.
Does preoperative pain education reduce preoperative anxiety?
Time Frame: Baseline (preoperatively, before surgery) and postoperatively at 1 hour, 6 hours, 12 hours, 24 hours, and 48 hours after surgery.

This study aims to investigate whether there is a significant difference in preoperative anxiety levels between patients who received preoperative pain education (intervention group) and those who did not (control group). The Surgical Anxiety Questionnaire - (SAQ) was used to assess patients anxiety.

In this 17-item scale, the individual is asked to rate how anxious or worried they are for each item on a five-point likert type scale:"Not at all", "A little bit" ''Moderately'' ''Very'' and ''Extremely''. The answers given to each item are scored between 0-4. There is no cut-off value, and as the score increases, the individual anxiety is interpreted as higher. Cronbachs alpha coefficient was reported to be 0.91 in the original version of the scale. The Turkish version of the surgical anxiety questionnaire consisted of a 3-factor structure, and the Cronbach alpha value was 0.93. As a result, the Turkish form of the scale contains 15 items.
Baseline (preoperatively, before surgery) and postoperatively at 1 hour, 6 hours, 12 hours, 24 hours, and 48 hours after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yeditepe University

Investigators

  • Study Director: İNCİ KIRTIL, Assist.Prof, Yeditepe Üniversitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2025

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

September 23, 2025

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E.83321821-805.02.03-472

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Decision not reached

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthroplasty

Clinical Trials on Pain education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe