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

NCT07362589 | Enrolling By Invitation

• 1 other identifier: E.83321821-805.02.03-472
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arthroplasty; Knee Replacement; Hip Replacement; Pain Management

Keywords

Postoperative Pain; Nursing; Patient Education

Outcome Measures

Primary Outcomes (2)

• 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?"

  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?

  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.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Pain Education

Other: Pain education

Control Group

NO INTERVENTION

No education no video

Interventions

Pain education OTHER

education booklet and video

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (1)

Yeditepe Üniversitesi Hastanesi

Istanbul, Kayişdaği, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• İNCİ KIRTIL, Assist.Prof

  Yeditepe Üniversitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hemşire Ceren Üstün

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: January 23, 2026
• Study Start: July 30, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)