Pain ManagementPain-AnxietyNCT07362589
Effect of Preoperative Pain Education on Anxiety, Pain, and Analgesic Use in Total Knee and Hip Replacement Patients
A study testing Pain education in people with Pain Management and Arthroplasty, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management, Arthroplasty, Knee Replacement
- What is being tested?
- Pain education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Yeditepe Üniversitesi Hastanesi
Istanbul, Kayişdaği
About this study
Official 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
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
Read the 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.
- Conditions
- Pain Management, Arthroplasty, Knee Replacement, Hip Replacement
- Being tested
- Pain education
- Keywords
- Postoperative Pain, Nursing, Patient Education
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain educationOther
education booklet and video
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Pain Education Receives: Other: Pain education |
| Control Group | No intervention | No education no video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (preoperatively, before surgery) and postoperatively at 1 hour, 6 hours, 12 hours, 24 hours, and 48 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start30 Jul 2025
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Ustun, Yeditepe University
- Investigators
- İNCİ KIRTIL, Assist.Prof, Study director, Yeditepe Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362589
- Sponsor's protocol ID
- E.83321821-805.02.03-472
- Acronym
- Pain-Anxiety
- Status last verified
- Jan 2026
- First submitted
- 23 Sep 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Decision not reached
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07362589
- Acronym / sponsor ID
- Pain-Anxiety / E.83321821-805.02.03-472
- Conditions
- Pain Management, Arthroplasty, Knee Replacement, Hip Replacement
- Keywords
- Postoperative Pain, Nursing, Patient Education
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 23 Jan 2026 (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 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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Pain educationPain Education |
| Control Group | No intervention | –No education no video |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (6 listed)
- Patients who do not meet the specified inclusion criteria will not be included in the study.
- 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
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 educationeducation booklet and video | Other | Experimental Group |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes. Decision not reached
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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.
İNCİ KIRTIL, Assist.Prof study director
Yeditepe Üniversitesi
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 education in people with Pain Management and Arthroplasty, run by Yeditepe 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 10 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 23 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
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 study lists 2 primary outcomes in all. 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 23 Jan 2026.