Total Joint ArthroplastyNCT07194252
The Effect of Guided Imagery Technique on Anxiety, Pain, and Analgesic Use in Total Joint Arthroplasty Patients
A study testing Guided imagery technique application in people with Total Joint Arthroplasty, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study will investigate the effects of guided imagery on preoperative anxiety and postoperative pain and analgesic consumption in patients undergoing total joint arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Joint Arthroplasty
- What is being tested?
- Guided imagery technique application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Sep 2025to 22 Jun 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
- Patients who have undergone unilateral arthroplasty surgery,
- Without cognitive impairment,
- Who speak and write Turkish,
- Without hearing or vision problems,
- Without any other acute illness causing pain or anxiety,
- Who received the same analgesic agent in the treatment protocol during the postoperative period,
- And who volunteered to participate in the study will be included.
Who cannot join
- Having a diagnosis of chronic pain syndrome or neuropathic pain,
- Having a diagnosis of psychiatric illness/being under treatment
- Continuous use of analgesic/sedative medication that may affect the pain threshold,
- Hearing impairment or severe cognitive impairment that prevents participation in guided imagery applications.
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
Zonguldak Atatürk State Hospital
Zonguldak
Zonguldak Atatürk State Hospital, 0372 252 19 00, zonguldakdhs4@saglik.gov.tr
BÜŞRA ERGEN TURAN, Lecturer
About this study
Official title: The Effect of Guided Imagery Applied Before and After Surgery on Surgical Anxiety, Pain, and Analgesic Consumption in Patients Undergoing Total Joint Arthroplasty: A Randomized Controlled Trial
This randomized controlled study will investigate the effects of guided imagery on preoperative anxiety and postoperative pain and analgesic consumption in patients undergoing total joint arthroplasty. Conducted between September 2025 and June 2026 at a public hospital in Zonguldak, Turkey, the study will include patients scheduled for total joint arthroplasty following ethics committee approval. The intervention group will receive guided imagery twice preoperatively and once daily at 48 and 72 hours postoperatively. Outcomes will be assessed using the Surgical Anxiety Scale, surgery-specific anxiety scale, Numerical Rating Scale (NRS), and analgesic consumption tracking.
Read the detailed description
This study aimed to investigate the effects of preoperative guided imagery on anxiety and postoperative guided imagery on pain intensity and analgesic consumption in patients undergoing total joint arthroplasty. This randomized controlled trial (RCT) study's population consisted of patients undergoing total joint arthroplasty at the Orthopedics and Traumatology Clinic of a public hospital in Zonguldak province between September 2025 and June 2026. The required sample size and power calculations for this study were performed using the G*Power program, with an effect size of 0.76 for the independent samples t-test. The minimum number of participants to provide 80% test power at a 95% confidence level was 58 for each surgical group, totaling 116 participants. The following data collection tools will be used: a "Descriptive Patient Information Form," a "Surgical Anxiety Scale," a "Surgery-Specific Anxiety Scale," a "Numerical Rating Scale (NRS)," and an "Analgesic Consumption Tracking Form." In the first stage, the "Descriptive Patient Information Form" will be administered to both the intervention and control groups. Then, surgical anxiety levels will be assessed using the "Surgical Anxiety Scale" and the "Surgery-Specific Anxiety Scale" in both the intervention and control groups. Guided imagery will then be administered to the intervention group twice preoperatively (in the afternoon and evening) one day before the scheduled surgery date and once at the 48th and 72nd hours postoperatively. At the end of the intervention, the "Surgical Anxiety Scale" and the "Surgery-Specific Anxiety Scale" will be administered again to the intervention group. In the postoperative period, the pain intensity of the intervention group will be measured with the "NRS" at the 48th and 72nd postoperative hours, before and immediately after the intervention. The surgical anxiety levels of the control group patients will be assessed simultaneously with the intervention group using the "Surgical Anxiety Scale" and "Surgery-Specific Anxiety Scale" without any intervention. In the postoperative period, the pain intensity of the control group will be measured with the "NRS" at the 48th and 72nd postoperative hours and will be measured again after these measurements simultaneously with the intervention group. Finally, the analgesic consumption of the intervention and control groups will be assessed on the 2nd and 3rd postoperative days using the "Analgesic Consumption Tracking Form," concluding the intervention phase. Microsoft-Excel 2019 and International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS) 22.0 will be used for data analysis.
- Conditions
- Total Joint Arthroplasty
- Being tested
- Guided imagery technique application
- Keywords
- pain, anxiety, analgesic, total joint arthroplasty
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided imagery technique applicationOther
Intervention is a guided imagery technique designed for patients undergoing total joint arthroplasty. It will be administered in a total of 4 sessions: once daily on the day before surgery, twice daily on the day of surgery, and once daily on the 2nd and 3rd days after surgery, accompanied by imagery scenarios developed in accordance with the Compact Disc (CD) and literature developed by the Turkish Psychological Association. The study aims to examine its effects on surgical anxiety levels, postoperative pain intensity, and analgesic consumption. This approach is structured as a non-pharmacological method specific to surgical nursing practice and differs from previous similar studies in that it is applied in both the preoperative and postoperative periods using the same sample in the literature.
| Study group | Role | What they receive |
|---|---|---|
| intervention Grubs | Experimental | The intervention group's surgical anxiety levels were assessed using the "Surgical Anxiety Scale" during the preoperative period. Subsequently, at the relevant clinic, the scale was administered twice on the day before the scheduled surgery date (at noon and in the evening) and once each at 48 and 72 hours post-surgery, for a total of four times. At the end of the application, the "Surgical Anxiety Scale" and the "Surgical-Specific Anxiety Scale" will be reapplied to the intervention group. In the postoperative period, participants' pain intensity will be measured using the "NRS" at 48 hours postoperatively before the intervention, immediately after the intervention, and at 72 hours before the intervention and immediately after the intervention. Receives: Other: Guided imagery technique application |
| Control Grubs | No intervention | During the preoperative period, nursing care will be provided according to the routine care protocol of the clinic where the study is conducted. Subsequently, participants' levels of surgical anxiety will be assessed using the "Anxiety Scale Specific to Surgery" simultaneously with the intervention group patients. In the postoperative period, participants' pain intensity will be measured using the "NRS" at 48 and 72 hours postoperatively and will be measured again 60 minutes after the measurements (simultaneously with the intervention group patients). In the final stage, the analgesic consumption of the intervention and control groups will be evaluated on the 2nd and 3rd days of the postoperative period using the "Analgesic Consumption Tracking Form" to assess the administration status of the analgesic drugs included in the treatment protocol, and the application phase of the study will be completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Anxiety Scale
The scale was developed in Turkish by Karanci and Dirik (2003) and is a 5-point Likert-type scale (1: Strongly disagree, 5: Strongly agree). The scale consists of 10 statements covering fears that patients may experience regarding surgery. The maximum score that can be obtained from the scale is 50. High scores on the scale reflect anxiety about experiencing pain, dying during surgery, and complications and restrictions that may arise after surgery. The Cronbach's Alpha coefficient for the scale was found to be 0.79.
Measured: September 2025-June 2026 (9 months)
Secondary outcomes (2)
Numerical Rating Scale
The NRS is a single-dimensional scale that uses 11 numbers (ranging from 0 to 10) to measure pain intensity. The patient is asked to select the number that best reflects their pain intensity, where 0 = no pain and 10 = the worst (unbearable) pain. The NRS has been shown to be a valid and reliable measurement tool for assessing postoperative acute pain intensity in adults and the elderly, as well as in elderly patients with mild to moderate cognitive impairment, and is widely used in clinical and research settings.
Measured: September 2025-June 2026 (9 months)
Analgesic Consumption Tracking Form
This form is used to evaluate analgesic consumption on the 2nd and 3rd days after surgery for patients in the intervention and control groups to examine the effect of guided imagery on analgesic consumption in the postoperative period. This form, created by the researcher, aims to inquire about and compare the analgesic agent used, the dose, the method and frequency of administration, and the analgesic agent used in case of need in the intervention and control groups.
Measured: September 2025-June 2026 (9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start22 Sep 2025 (estimated)
- Primary completion22 May 2026 (estimated)
- Study completion22 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Joint ArthroplastyStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BTuran, Zonguldak Bulent Ecevit University
- Investigators
- Gülay YAZICI, Assoc. Prof., Study director, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194252
- Sponsor's protocol ID
- YBU-HEM-RK-01
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Guided Imagery Applied Before and After Surgery on Surgical Anxiety, Pain, and Analgesic Consumption in Patients Undergoing Total Joint Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07194252
- Acronym / sponsor ID
- YBU-HEM-RK-01
- Conditions
- Total Joint Arthroplasty
- Keywords
- pain, anxiety, analgesic, total joint arthroplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 22 Sep 2025 (estimated)
- Primary completion
- 22 May 2026 (estimated)
- Study completion
- 22 Jun 2026 (estimated)
- First posted
- 26 Sep 2025 (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 study will investigate the effects of guided imagery on preoperative anxiety and postoperative pain and analgesic consumption in patients undergoing total joint arthroplasty. Conducted between September 2025 and June 2026 at a public hospital in Zonguldak, Turkey, the study will include patients scheduled for total joint arthroplasty following ethics committee approval. The intervention group will receive guided imagery twice preoperatively and once daily at 48 and 72 hours postoperatively. Outcomes will be assessed using the Surgical Anxiety Scale, surgery-specific anxiety scale, Numerical Rating Scale (NRS), and analgesic consumption tracking.
Detailed description
This study aimed to investigate the effects of preoperative guided imagery on anxiety and postoperative guided imagery on pain intensity and analgesic consumption in patients undergoing total joint arthroplasty. This randomized controlled trial (RCT) study's population consisted of patients undergoing total joint arthroplasty at the Orthopedics and Traumatology Clinic of a public hospital in Zonguldak province between September 2025 and June 2026. The required sample size and power calculations for this study were performed using the G*Power program, with an effect size of 0.76 for the independent samples t-test. The minimum number of participants to provide 80% test power at a 95% confidence level was 58 for each surgical group, totaling 116 participants. The following data collection tools will be used: a "Descriptive Patient Information Form," a "Surgical Anxiety Scale," a "Surgery-Specific Anxiety Scale," a "Numerical Rating Scale (NRS)," and an "Analgesic Consumption Tracking Form." In the first stage, the "Descriptive Patient Information Form" will be administered to both the intervention and control groups. Then, surgical anxiety levels will be assessed using the "Surgical Anxiety Scale" and the "Surgery-Specific Anxiety Scale" in both the intervention and control groups. Guided imagery will then be administered to the intervention group twice preoperatively (in the afternoon and evening) one day before the scheduled surgery date and once at the 48th and 72nd hours postoperatively. At the end of the intervention, the "Surgical Anxiety Scale" and the "Surgery-Specific Anxiety Scale" will be administered again to the intervention group. In the postoperative period, the pain intensity of the intervention group will be measured with the "NRS" at the 48th and 72nd postoperative hours, before and immediately after the intervention. The surgical anxiety levels of the control group patients will be assessed simultaneously with the intervention group using the "Surgical Anxiety Scale" and "Surgery-Specific Anxiety Scale" without any intervention. In the postoperative period, the pain intensity of the control group will be measured with the "NRS" at the 48th and 72nd postoperative hours and will be measured again after these measurements simultaneously with the intervention group. Finally, the analgesic consumption of the intervention and control groups will be assessed on the 2nd and 3rd postoperative days using the "Analgesic Consumption Tracking Form," concluding the intervention phase. Microsoft-Excel 2019 and International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS) 22.0 will be used for data analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| intervention Grubs | Experimental | Other: Guided imagery technique applicationThe intervention group's surgical anxiety levels were assessed using the "Surgical Anxiety Scale" during the preoperative period. Subsequently, at the relevant clinic, the scale was administered twice on the day before the scheduled surgery date (at noon and in the evening) and once each at 48 and 72 hours post-surgery, for a total of four times. At the end of the application, the "Surgical Anxiety Scale" and the "Surgical-Specific Anxiety Scale" will be reapplied to the intervention group. In the postoperative period, participants' pain intensity will be measured using the "NRS" at 48 hours postoperatively before the intervention, immediately after the intervention, and at 72 hours before the intervention and immediately after the intervention. |
| Control Grubs | No intervention | –During the preoperative period, nursing care will be provided according to the routine care protocol of the clinic where the study is conducted. Subsequently, participants' levels of surgical anxiety will be assessed using the "Anxiety Scale Specific to Surgery" simultaneously with the intervention group patients. In the postoperative period, participants' pain intensity will be measured using the "NRS" at 48 and 72 hours postoperatively and will be measured again 60 minutes after the measurements (simultaneously with the intervention group patients). In the final stage, the analgesic consumption of the intervention and control groups will be evaluated on the 2nd and 3rd days of the postoperative period using the "Analgesic Consumption Tracking Form" to assess the administration status of the analgesic drugs included in the treatment protocol, and the application phase of the study will be completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who have undergone unilateral arthroplasty surgery,
- Without cognitive impairment,
- Who speak and write Turkish,
- Without hearing or vision problems,
- Without any other acute illness causing pain or anxiety,
Key exclusion criteria (4 listed)
- Having a diagnosis of chronic pain syndrome or neuropathic pain,
- Having a diagnosis of psychiatric illness/being under treatment
- Continuous use of analgesic/sedative medication that may affect the pain threshold,
- Hearing impairment or severe cognitive impairment that prevents participation in guided imagery applications.
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 |
|---|---|---|
| Guided imagery technique applicationIntervention is a guided imagery technique designed for patients undergoing total joint arthroplasty. It will be administered in a total of 4 sessions: once daily on the day before surgery, twice daily on the day of surgery, and once daily on the 2nd and 3rd days after surgery, accompanied by imagery scenarios developed in accordance with the Compact Disc (CD) and literature developed by the Turkish Psychological Association. The study aims to examine its effects on surgical anxiety levels, postoperative pain intensity, and analgesic consumption. This approach is structured as a non-pharmacological method specific to surgical nursing practice and differs from previous similar studies in that it is applied in both the preoperative and postoperative periods using the same sample in the literature. | Other | intervention Grubs |
Primary outcome
Surgical Anxiety Scale
Time frame: September 2025-June 2026 (9 months)
The scale was developed in Turkish by Karanci and Dirik (2003) and is a 5-point Likert-type scale (1: Strongly disagree, 5: Strongly agree). The scale consists of 10 statements covering fears that patients may experience regarding surgery. The maximum score that can be obtained from the scale is 50. High scores on the scale reflect anxiety about experiencing pain, dying during surgery, and complications and restrictions that may arise after surgery. The Cronbach's Alpha coefficient for the scale was found to be 0.79.
2 secondary outcomes
Numerical Rating Scale
Time frame: September 2025-June 2026 (9 months)
Analgesic Consumption Tracking Form
Time frame: September 2025-June 2026 (9 months)
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 26 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Gülay YAZICI, Assoc. Prof. study director
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided imagery technique application in people with Total Joint Arthroplasty, run by Ankara Yildirim Beyazıt 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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 26 Sep 2025. 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?
Contact Büşra ERGEN TURAN, Lecturer (+90543810595, brergen62@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Anxiety Scale (time frame: September 2025-June 2026 (9 months)). 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 26 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.