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Enrolling by Invitation

NCT Number: NCT07362589

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

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

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Key information

Conditions

Pain Management Agnosia Arthroplasty Hip Replacement Knee Replacement Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeditepe Üniversitesi Hastanesi

Istanbul, Kayişdaği, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain Education

Other

education booklet and video

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Registry information

Official study title

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

Acronym: Pain-Anxiety

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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